[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"overweight--obesity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:overweight--obesity":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,43,62,105,137,166,200,224,246,276,307,332,354,380,405,437,463,483,513,549,575,608,639,670,707],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100652872","phase-1-phase-1-clinical-study-of-mwn110-injection-in-healthy-participants-and-overweight-or-obese-participants-100652872",false,"NCT07779980","Phase 1 Clinical Study of MWN110 Injection in Healthy Participants and Overweight or Obese Participants","A Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Subcutaneous Administrations of MWN110 Injection in Healthy Participants and Overweight or Obese Participants","Inclusion Criteria:\n\n1. Male or female participants aged 18 to 65 years (inclusive) at the time of signing the informed consent form (ICF); the proportion of either gender shall not be less than 1\u002F3.\n2. Male participants with body weight not less than 50 kg, female participants with body weight not less than 45 kg; body mass index (BMI) within 20.0 to 40.0 kg\u002Fm\\^2 (inclusive).\n3. Female participants must have no plans for pregnancy or egg donation from 14 days before the first dose to 6 months after the last dose and must agree to use effective contraceptive measures to avoid pregnancy; male participants must have no plans for fathering a child or sperm donation from the first dose to 6 months after the last dose and must agree to use effective contraceptive measures to avoid causing partner pregnancy.\n\nExclusion Criteria:\n\n1. Known or suspected allergy to the investigational product or its excipients, or history of severe allergy (including any food or drug allergy).\n2. Body weight change \\>5% within 3 months prior to screening (weight change % = \\[maximum weight in 3 months - minimum weight in 3 months\\] \u002F maximum weight in 3 months x 100%).\n3. Diagnosed with secondary overweight or obesity.\n4. History of pancreatitis (chronic pancreatitis or idiopathic acute pancreatitis); serum amylase or lipase above the upper limit of normal.\n5. Known history of disease or comorbidity affecting skeletal muscle protein.\n6. At screening, the presence of active acne, pyogenic dermatosis, allergic dermatosis, inflammatory dermatosis, infectious dermatosis, unhealed skin wounds, extensive skin lesions, or skin abnormalities such as vegetations or masses, judged by the investigator as unsuitable for participation.\n7. History of infectious disease within 4 weeks prior to screening (judged by the investigator as potentially significantly affecting safety evaluation), history of severe trauma, or history of major surgery within 3 months, or planned surgery during the study period.\n8. At screening, any laboratory test meeting any of the following criteria: a) fasting blood glucose \\>6.1 mmol\u002FL or \\\u003C3.9 mmol\u002FL; b) alanine aminotransferase, aspartate aminotransferase, or total bilirubin \\>1.5 × upper limit of normal (ULN); c) estimated glomerular filtration rate \\\u003C70 mL\u002Fmin\u002F1.73 m² (CKD-EPI equation) or urinary protein positive (1+ or above); d) fasting triglycerides ≥3.42 mmol\u002FL (Part 1) or \\>5.64 mmol\u002FL (Part 2); e) hemoglobin \\\u003C100 g\u002FL (females) or \\\u003C110 g\u002FL (males); f) blood uric acid (UA) \\>540 μmol\u002FL.\n9. At screening, 12-lead electrocardiogram showing heart rate \\\u003C50 bpm or \\>100 bpm, second-degree or third-degree atrioventricular block, long QT syndrome, or QTcF \\>460 ms (female) or \\>450 ms (male), or other electrocardiogram abnormalities judged by the investigator as requiring pharmacological intervention.\n10. Participants who have undergone dieting or weight-loss treatment within 30 days prior to the first dose, or who have experienced major changes in lifestyle habits.\n11. Use of GLP-1 receptor agonists, weight-loss drugs, systemic corticosteroids (oral or intravenous for more than 7 days), or psychiatric medications within 3 months before the first dose.\n12. Engaged in strenuous muscle exercise, high-intensity resistance training, or regular muscle-strengthening activities within 30 days before the first dose.",true,"ALL","18 Years","65 Years",{"count":22,"type":23},103,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","This study is a multicenter, randomized, double-blind, placebo-controlled, single and multiple ascending-dose phase 1 clinical trial aimed at evaluating the safety, tolerability, PK, PD, and immunogenicity of MWN110 Injection in healthy participants and overweight or obese participants.\n\nThe study consists of two parts: Part 1, a single ascending dose (SAD) study in healthy participants with 8 dose cohorts; and Part 2, a multiple ascending dose (MAD) study in overweight or obese participants with 3 dose cohorts, with a dosing frequency of once weekly or once every 4 weeks.\n\nApproximately 103 participants will be enrolled. The primary endpoint is safety and tolerability, assessed by adverse events, vital signs, physical examination, laboratory tests, 12-lead electrocardiogram, and ophthalmic examination. Secondary endpoints include single-dose and multiple-dose PK parameters, PD parameters (body weight, BMI, waist circumference, muscle mass, body fat percentage, visceral fat, subcutaneous fat, bone mineral density), and immunogenicity (anti-drug antibodies).",[29],"Overweight , Obesity","NOT_YET_RECRUITING","2026-08-18",{"date":33,"type":34},"2026-08-21","ACTUAL",{"date":36,"type":23},"2026-08-26",{"date":38,"type":23},"2027-08",{"name":40,"class":41},"Shanghai Minwei Biotechnology Co., Ltd","INDUSTRY",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":50,"targetDuration":4,"studyType":24,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":42},"100652800","phase-3-phase-3-study-of-mwn109-injection-in-participants-with-overweight-or-obesity-100652800","NCT07778693","Phase 3 Study of MWN109 Injection in Participants With Overweight or Obesity","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of MWN109 Injection in Non-Diabetic Participants With Overweight or Obesity","Inclusion Criteria:\n\n1. Male or female aged 18 to 65 years (inclusive) at the time of signing the informed consent form;\n2. Body weight ≥ 70 kg (males) or ≥ 60 kg (females), with BMI ≥ 28 kg\u002Fm² (obesity), or 24 kg\u002Fm² ≤ BMI \\\u003C 28 kg\u002Fm² (overweight) with at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, pre-diabetes, obstructive sleep apnea syndrome, metabolic dysfunction-associated steatotic liver disease, weight-bearing joint pain, cardiovascular disease, polycystic ovary syndrome);\n3. Resting heart rate ≥ 55 bpm and ≤ 100 bpm (during screening and prior to randomization per 12-lead ECG);\n4. Self-reported or documented history of dietary and exercise-based weight management for at least 12 weeks prior to screening, with \\\u003C 5.0% weight change during the 12 weeks prior to screening, and ability to maintain the required diet and exercise behavior during the study;\n5. Participants of childbearing potential must agree to use highly effective contraception from 14 days before signing the ICF until 4 months after the last dose, with no plans for pregnancy or oocyte donation; male participants must agree to use highly effective contraception from signing the ICF until 4 months after the last dose, with no plans for fathering children or sperm donation.\n\nExclusion Criteria:\n\n1. Known allergic constitution (allergy to 3 or more foods or drugs), or allergy to GLP-1 receptor agonists or any component of the investigational product, or severe allergic diseases at screening, or history of severe drug allergy.\n2. Use of any anti-hyperglycemic agents, weight-affecting medications, or prescription weight-loss medications for weight control within 12 weeks prior to screening; over-the-counter weight-loss medications or appetite suppressants within 4 weeks.\n3. Laboratory abnormalities: ALT or AST ≥ 3×ULN; total bilirubin ≥ 1.5×ULN; eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m²; hemoglobin \\\u003C 110 g\u002FL (males) or \\\u003C 100 g\u002FL (females); serum calcitonin ≥ 35 ng\u002FL; TSH \\> 6.0 or \\\u003C 0.4 mIU\u002FL; fasting triglycerides ≥ 5.64 mmol\u002FL; serum amylase or lipase \\> 2.0×ULN.\n4. Known or screening-detected ECG abnormalities with significant safety risk, including: uncontrolled arrhythmias, second-degree or third-degree AV block, ST-T changes suggesting myocardial ischemia, QTcF \\> 450 ms, family history of long QT or Brugada syndrome.\n5. Has a medical history or evidence of any of the following conditions: secondary or drug-induced overweight or obesity; diagnosis of type 1 or type 2 diabetes mellitus in the past or at screening, or at least one laboratory finding suggestive of diabetes identified at screening: HbA1c ≥ 6.5%, fasting plasma glucose ≥ 7.0 mmol\u002FL, random plasma glucose ≥ 11.1 mmol\u002FL, or 2-hour plasma glucose during the oral glucose tolerance test (OGTT) ≥ 11.1 mmol\u002FL; acute or chronic pancreatitis; gallstones\u002Fcholecystitis (with exceptions); thyroid C-cell carcinoma or MEN 2A\u002F2B; prior bariatric surgery (with exceptions); moderate or severe depression (PHQ-9 ≥ 15), other severe psychiatric disorders, or suicidal risk; malignancy within 5 years (with exceptions); cardiac disease within 6 months; premature beats or tachycardia; cerebrovascular event within 6 months; uncontrolled hypertension; thyroid dysfunction; gastric emptying abnormalities; organ transplant history; autoimmune disease; previous or planned weight-loss treatment.\n6. Pregnant or breastfeeding women.\n7. Previous treatment with MWN109 injection.",{"count":51,"type":23},760,[53],"PHASE3","This is a phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of MWN109 injection in non-diabetic participants with overweight or obesity.\n\nApproximately 760 participants will be enrolled. All participants will be stratified by gender (male or female) and baseline BMI level, and then randomized 1:1:1:1 to 4 treatment groups, with 190 participants per group. All treatment groups will implement dose titration to achieve the target dose.\n\nThe study comprises a screening period of up to 2 weeks, a 52-week treatment period, and a 4-week follow-up period, for a total study duration of 58 weeks. The primary endpoints are the percentage change in body weight from baseline and the proportion of participants achieving ≥5% weight reduction from baseline at Week 52. The secondary endpoints include the proportions of participants achieving ≥10% and ≥15% weight reduction from baseline, as well as the change from baseline in waist circumference at Week 52.",[29],{"date":33,"type":34},{"date":58,"type":23},"2026-09-01",{"date":60,"type":23},"2027-11",{"name":40,"class":41},{"id":63,"slug":64,"hasResults":12,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":17,"sex":18,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":24,"phases":74,"briefSummary":76,"conditions":77,"keywords":85,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":42},"100648044","effect-of-probiotics-on-appetite-regulation-in-adults-with-overweightobesity-100648044","NCT07715955","Effect of Probiotics on Appetite Regulation in Adults With Overweight\u002FObesity","Probiotic Regulation of Food Intake Through Satiety Stimulation and Gut Microbiota Modulation","ProBiSat","Inclusion Criteria:\n\n* Men and women, aged between 20-70 years\n* BMI ³ 25 kg\u002Fm2\n* Stable body weight (weight gain or loss \\\u003C 3 kg in the past three months)\n* Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study\n* No difficult venipuncture as evidenced during the screening visit\n\nExclusion Criteria:\n\n* Diabetic patients (type 1 and type 2)\n* Abuse of drugs\n* More than 2 units alcoholic consumptions per day for women and 3 for men\n* Use of products or dietary supplements known to interfere with the main outcomes 3 months prior to the start of the study as judged by the principal investigators\n* Gastrointestinal disease (including IBD and IBS)\n* Use of an investigational product within another biomedical intervention trial within the previous 1-month\n* Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, autoimmune disease and rheumatoid arthritis\n* Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident\n* use of lipid- and glucose lowering medication, corticosteroid use\n* Psychiatric diagnoses including clinical depression\n* Intolerances or dietary habits that might interfere with the study (i.e. lactose intolerance or veganism)\n* pregnancy\n* smoking, vaping\n* use of antibiotics up to 3 months prior to the study","20 Years","70 Years",{"count":73,"type":23},98,[75],"NA","The goal of this 16-week randomised, placebo-controlled parallel study is to investigate the effect of a newly formed probiotic supplement on satiety and gut microbiota composition in healthy men and women with overweight or obesity form 20-70 years old. The main question it aims to answer is:\n\nDoes the probiotic supplement increase feelings of satiety and alter gut microbiota composition?\n\nParticipants will:\n\n* Receive a daily dose of 6 g probiotic supplement (packed in sachets of 3 g) or placebo for 16 weeks.\n* Visit the research unit 3 times at baseline, week 8 and week 16 of the intervention for blood draws and delivering fecal samples.\n* Keep a study diary to report deviations from their daily habits and fill in food questionnaires.",[78,79,29,80,81,82,83,84],"Healthy","Overweight (BMI > 25)","Male","Female","Adults","Satiety and Food Intake","Gut Microbiota Modulation",[86,87,88,82,78,89,90,91,92,93],"Probiotics","Overweight","Obesity","Satiety","Food intake","Gut microbiota","Gut microbiota composition","Gut microbiota modulation","RECRUITING","2026-08-10",{"date":97,"type":34},"2026-08-12",{"date":99,"type":34},"2026-03-18",{"date":101,"type":23},"2029-08-18",{"name":103,"class":104},"Maastricht University Medical Center","OTHER",{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":4},"100651355","i-opera-a-european-study-testing-a-new-way-to-do-health-research-100651355","NCT07759544","I-OPERA: A European Study Testing a New Way to Do Health Research.","The I-OPERA Study: IQVIA Obesity Pilot in Europe to Test a New Patient-centric Research Approach","I-OPERA","Inclusion Criteria:\n\n* Age ≥18 years\n* Resident in England, France, or Germany\n* Self-reported height and weight corresponding to a calculated BMI ≥27 kg\u002Fm²\n\nExclusion Criteria:\n\n* Unable to provide electronic informed consent form (ICF)\n* Unable to name at least one HCP involved in their care and the affiliated institution, where applicable\n* Unwilling to authorise medical records access via DSAR (where applicable) or direct upload\n* Unable to complete online surveys (approximately 30 minutes) on own device (computer, smartphone, or tablet)\n* Participants whose HCPs are exclusively located outside the participant's country of residence, where applicable",{"count":114,"type":23},105,"OBSERVATIONAL","The goal of this observational pilot study is to evaluate whether a participant-mediated, direct-to-participant research approach is a feasible and effective way to collect health data from adults living with obesity in England, France, and Germany. This approach allows participants to take part remotely and to help researchers access their medical records using their data access rights, while also providing information directly through an online questionnaire.\n\nThe main questions it aims to answer are:\n\n1. Can medical records be successfully obtained through participant-authorized data subject access requests (DSARs), and how long does the process take? (In France, DSAR Authorization Form is not applicable and participants are asked to directly share their medical records of interest.)\n2. How well do healthcare providers comply with requests for medical records? (In France, DSAR Authorization Form is not applicable and participants are asked to directly share their medical records of interest. Therefore, their healthcare providers are not contacted.)\n3. Is the information collected through this approach complete and of sufficient quality for research purposes?\n4. How closely does information reported by participants match the information contained in their medical records?\n5. Are there differences in outcomes between countries and regions? Researchers will also explore the demographic, clinical and socio-economic characteristics of participants, assess health-related quality of life, evaluate experiences related to \"food noise\", and compare quality-of-life results across countries.\n\nThere is no comparison group or study treatment, as this is an observational study.\n\nParticipants will:\n\n* Provide electronic informed consent to participate in the study.\n* Authorize requests for their medical records using their legal right to access personal health information (DSAR). (In France, DSAR Authorization Form is not applicable and participants are asked to directly share their medical records of interest.)\n* Complete an online questionnaire about their health, quality of life, and experiences related to obesity.\n* Allow researchers to combine information from questionnaire with data obtained from their medical records.\n* Participate entirely remotely through the IQVIA Health Research Space (HRS) platform, with no study site visits required.\n\nParticipation lasts for up to 90 days and includes completion of questionnaire and the medical record retrieval process. The study plans to enroll approximately 105 participants, with around 35 participants in each participating country.",[118,29],"Obesity (Disorder)",[120,121,122,123,124,88,125,126,127,128],"General Data Protection Regulation (GDPR)","Data Subject Access Request (DSAR) Authorization Form","patients-mediated Electronic Medical Records (EMRs)","Decentralized study","Direct to Participant (DtP)","Observational study","Non-interventional study","Real-world study","Pilot study","2026-08-07",{"date":97,"type":34},{"date":132,"type":23},"2026-11",{"date":134,"type":23},"2027-03",{"name":136,"class":41},"IQVIA RDS Spain, SL",{"id":138,"slug":139,"hasResults":12,"nctId":140,"briefTitle":141,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":17,"sex":18,"minAge":143,"maxAge":71,"enrollmentInfo":144,"targetDuration":4,"studyType":24,"phases":146,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":42},"100650378","impact-of-antioxidant-rich-supplementation-on-skin-carotenoids-status-antioxidant-status-and-cardiometabolic-health-in-overweight-and-obese-individuals-100650378","NCT07748468","Impact of Antioxidant-rich Supplementation on Skin Carotenoids Status, Antioxidant Status and Cardiometabolic Health in Overweight and Obese Individuals","Inclusion Criteria:\n\n* Able to give informed consent (AMT score ≥ 8 for older adults \\[65-70 years old\\])\n* Adults 21-70 years old\n* English-literate\n* Have venous access sufficient to allow for blood sampling as per the protocol\n* No drastic change of diet for the past 1 year\n* If taking medication, has been consistently taking antihypertensive\u002Fcholesterol-lowering\u002Ftype-2 diabetic medication for more than 3 years prior to starting the study\n\nExclusion Criteria:\n\n* Weight change \\> 3kg in the past 3 months\n* Exercising vigorously over the past 3 months\n* Taking medications or dietary supplements which may impact eye\u002Fskin health\n* Taking lipid-lowering and blood pressure controlling medications less than 3 years\n* Smoking\n* Drinking more than 2 alcoholic drinks per day\n* Pregnant, lactating, or planning pregnancy in the next 6 months","21 Years",{"count":145,"type":23},83,[75],"This study aims to evaluate the effects of antioxidant-rich supplementation on skin carotenoid status, antioxidant status, and cardiometabolic health in overweight and obese individuals. The study may provide additional scientific evidence to support the further refinement of current dietary and nutritional recommendations.",[29,149],"Antioxidant Status",[87,151,152,153,154,155,156],"Obese","Antioxidants","Long-term","Body composition","Cardiometabolic health","Skin carotenoid","2026-08-02",{"date":159,"type":34},"2026-08-05",{"date":161,"type":23},"2026-08-15",{"date":163,"type":23},"2027-12-31",{"name":165,"class":104},"National University of Singapore",{"id":167,"slug":168,"hasResults":12,"nctId":169,"briefTitle":170,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":173,"targetDuration":4,"studyType":24,"phases":175,"briefSummary":176,"conditions":177,"keywords":182,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":197,"leadSponsor":198,"locationsCount":42},"100646313","combining-fasting-and-fibre-interventions-to-optimise-their-gut-microbiome-mediated-health-benefits-100646313","NCT07691736","Combining Fasting and Fibre Interventions to Optimise Their Gut Microbiome-mediated Health Benefits","CoFFIe","Inclusion Criteria:\n\n* Men and women\n* Age: 18-65 years old\n* Fasting for 10±4 days at the Buchinger Wilhelmi clinic in Überlingen\n* BMI ≥ 25 kg\u002Fm²\n* Signed informed consent\n\nExclusion Criteria:\n\n* intake of antibiotics up to 2 months prior the study\n* regular intake of pre-, post- and probiotics up to 2 months prior the study\n* diagnosed Crohn's disease, Ulcerative colitis, IBD, coeliac disease\n* medicated high blood pressure\n* diagnosed diabetes mellitus type I\n* medicated diabetes mellitus type II\n* diagnosed kidney stone\n* active malignant disease\n* known substance addiction\n* pregnancy or breastfeeding\n* diagnosed with cachexia, anorexia nervosa, advanced kidney, liver or cerebrovascular insufficiency\n* inability to sign the informed consent\n* participation in another study",{"count":174,"type":23},75,[75],"This study builds on the knowledge that fasting provides metabolic health benefits and that prebiotic interventions can enhance the gut microbiome's metabolic output to likewise improve host health. Whether long-term fasting and dietary fibre interventions could be combined to achieve synergistic improvements in host metabolic health is however unknown. The goal is to provide a proof of concept in a human trial that supplementing 10±4 days fasting with dietary fibre synergistically improves metabolic outcomes via gut microbiome-mediated effects. To assess this, we aim to analyse gut microbiome changes, functional outputs, and key metabolic markers such as butyrate production, glycaemic control and ketosis.\n\nThe randomised controlled trial includes 75 participants and has two arms: one involving fasting with fibre supplementation (n = 50) and one involving fasting without fibre supplementation (n = 25). All participants will undergo a fasting period of 10±4 days according to the Buchinger Wilhelmi protocol, followed by a stepwise reintroduction of food of up to 4 days. As dietary fibre we will use maize-derived resistant starch type IV, selected based on its ability to stimulate beneficial gut microbes like Oscillibacter and corn starch as placebo. Two main visits will be conducted: before and at the end of the fasting period. During these visits, blood and stool samples will be collected, and questionnaires will be completed. Additionally, daily measurements of anthropometric parameters and well-being will be recorded. Stool samples will also be collected one month afterwards as a follow-up. Participants' metabolic health will be evaluated through various clinical parameters (e.g., body measurements, blood pressure, glycaemic control, ketones, well-being). Additionally, multi-omics data, including metagenomics and metabolomics, will provide insight into the composition of the microbiome, as well as its outputs and functions. Furthermore, the effects of fasting on extracellular vesicles in blood will be explored.",[178,179,180,181,29],"Fasting","Dietary Fibre","Gut Microbiome","Metabolism Changes",[183,184,185,186,187,188,189,190,191,192],"long-term fasting","fasting","continuous glucose monitoring","fibre supplementation","gut microbiome","metabolic health","resistant starch IV","metabolomics","ketosis","extracellular vesicles","2026-07-02",{"date":195,"type":34},"2026-07-09",{"date":58,"type":23},{"date":134,"type":23},{"name":199,"class":104},"Buchinger Wilhelmi Development & Holding GmbH",{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":207,"enrollmentInfo":208,"targetDuration":4,"studyType":24,"phases":210,"briefSummary":211,"conditions":212,"keywords":213,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":42},"100618465","efficacy-and-safety-of-akkermansia-muciniphila-akm-lab-01-for-overweight-and-obesity-100618465","NCT07331974","Efficacy and Safety of Akkermansia Muciniphila AKM Lab-01 for Overweight and Obesity","A Randomized, Double-blind, Placebo-controlled Trial to Access the Efficacy and Safety of Akkermansia Muciniphila AKM Lab-01 in Participents With Overweigh and Obesity","Inclusion Criteria:\n\n* 1\\) Age: 18-60 years old (inclusive); Gender: male or female.\n* 2\\) Body Mass Index (24.0≤BMI≤40.0 kg\u002Fm²).\n* 3\\) Has no taken any medications for metabolic control (e.g., for body weight, blood lipids, or blood glucose) within the past month.\n* 4\\) Has been attempting to manage weight primarily through lifestyle interventions (diet and exercise) for at least one month prior to screening.\n* 5\\) Processes adequate communication and cognitive abilities, is expected to be compliant with long-term medication, and has understood the nature, significance, potential benefits, inconveniences, and risks of the study prior to enrollment.\n* 6\\) For participants of childbearing potential (male or female): Must agree to use at least one medically approved form of contraception (e.g., intrauterine device \\[IUD\\], oral contraceptives, or condoms) throughout the trial. For female participants of childbearing potential: Must have a negative serum pregnancy test at screening and must be non-lactating.\n* 7\\) Voluntarily agrees to participate by signing the inform consent form and commits to follow the trial treatment plan and visit schedule.\n\nExclusion Criteria:\n\n* 1\\) A clear history of neurological or psychiatric disorders (including epilepsy and dementia).\n* 2\\) Hyperlipidemia due to secondary causes, such as nephrotic syndrome, hepatic diseases, hypothyroidism, or renal failure.\n* 3\\) Concurrent severe medical conditions deemed by the investigator to require immediate treatment, such as severe diabetes mellitus, hypertriglyceridemia, or cerebrovascular disease.\n* 4\\) Concurrent severe primary diseases of the liver, kidney, or hematopoietic system; or individuals with mental illness.\n* 5\\) Participants with a family history of genetically inherited metabolic disorders.\n* 6\\) Participants currently taking hepatotropic medications.\n* 7\\) Participants with a history of prior bariatric surgery.\n* 8\\) Presence of poorly controlled or unstable acute\u002Fchronic diseases, including but not limited to:\n\n  * Cardiovascular diseases: Unstable angina, myocardial infarction within the past 6 months, symptomatic congestive heart failure (NYHA Class Ⅱ or higher), severe arrhythmia, ect.\n  * Uncontrolled active infectious diseases, malignancies, ect.\n* 9\\) Participants with hepatic or renal insufficiency, defined as:\n\n  * Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \\> 2.5 × ULN (Upper Limit of Normal);\n  * Serum total bilirubin \\> 2.5 × ULN;\n  * Creatinine (Cr) \\> 1.5 × ULN.\n* 10\\) Urine amylase ≥ 1.5 × ULN, or any other laboratory abnormality deemed by the investigator to be clinically significant and incompatible with study participation.\n* 11\\) History of acute diabetic complications (e.g., diabetic ketoacidosis or hyperosmolar hyperglycemic state) within the past 3 months.\n* 12\\) History of gastrointestinal surgery within the past year, or the presence of severe, active gastrointestinal disease that is not stabilized and may affect drug absorption, distribution, metabolism, or excretion.\n* 13\\) Know hypersensitivity or allergy to any active ingredient or excipient of the investigational product.\n* 14\\) Use of antibiotic therapy or intake of probiotics\u002Fprebiotic supplements within 3 month prior to screening.\n* 15\\) Excessive alcohol consumption (defined as \\> 30 grams per day for men or \\> 20 gram, sraems) with the past 10 years.\n* 16\\) pregnant or lactating women.\n* 17\\) Any other medical condition that, in the judgement of the investigator, may put the participant at increased or be aggravated by participation in the study. The specific reason for exclusion based on this criterion must be documented.","60 Years",{"count":209,"type":23},200,[75],"This study is designed as a preliminary investigation to evaluate the weight-loss efficacy and safety of AKM Lab-01 in an overweight or obese population. It is an interventional, radomized, double-blind, placebo-controlled clinical trial. Participants who meet the eligibility criteria will be randomly assigned to receive AKM Lab-01 or a matching placebo. The intervention will be administered once daily for 3 months. Baseline metrics, along with blood, urine, and stool samples, will be collected from participants, before and after the AKM Lab-01 intervention. The analysis will focus on changes in body weight, blood lipids, blood glucose, and gut metagenomic profiles (from stool samples). Furthermore, metabolomic analysis of blood and stool samples will be conducted to explore the potential machanisms through which AMK Lab-01 influences body weight.",[29],[214,88,87,86],"Akkermansia Muciniphila","2026-06-25",{"date":217,"type":34},"2026-06-29",{"date":219,"type":23},"2026-07-01",{"date":221,"type":23},"2027-05-31",{"name":223,"class":41},"Moon (Guangzhou) Biotechnology Co., Ltd.",{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":42},"100644244","assessment-of-the-natural-history-and-prognostic-factors-of-therapeutic-response-in-sub-phenotypes-of-patients-with-obesity-the-bolobe-study-100644244","NCT07666425","ASSESSMENT OF THE NATURAL HISTORY AND PROGNOSTIC FACTORS OF THERAPEUTIC RESPONSE IN SUB-PHENOTYPES OF PATIENTS WITH OBESITY: THE BOLOBE STUDY","ASSESSMENT OF THE NATURAL HISTORY AND PROGNOSTIC FACTORS OF THERAPEUTIC RESPONSE IN SUB-PHENOTYPES OF PATIENTS WITH OBESITY: THE BOLOBE STUDY (BOLOgna for OBEsity Follow-up BOLOBE)","BOLOBE","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Body mass index (BMI) ≥ 30 kg\u002Fm², or BMI ≥ 25 kg\u002Fm² with at least one cardiometabolic comorbidity\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Obesity secondary to hypothalamic-pituitary disorders\n* Obesity secondary to adrenal disorders\n* Syndromic obesity",{"count":233,"type":23},10000,"The study is observational and single-center and involves (i) the establishment of a retrospective and prospective data collection, and (ii) the development of prognostic and predictive models of response to obesity therapies using statistical modeling and machine learning techniques, exclusively for research purposes.\n\nData collection will be carried out for each patient diagnosed with obesity or overweight whose first visit to the center occurred from January 1, 2000 up to the start of the study, as well as for patients accessing the center during the subsequent 5 years, including patients who died or were lost to follow-up.\n\nWith respect to the primary objective, an interim analysis is planned on the retrospective cohort only, once the collection of data already available at study start has been completed for patients with at least 5 years of follow-up.\n\nData related to instrumental and laboratory examinations and therapeutic interventions, including pharmacological treatments and group-based educational and behavioral therapies, conducted in accordance with routine clinical practice and the most recent relevant national and international guidelines, will be extracted from the electronic health records routinely used at the study center.",[236,29],"Obese Adults","2026-06-19",{"date":239,"type":34},"2026-06-24",{"date":241,"type":34},"2026-05-30",{"date":243,"type":23},"2038-03",{"name":245,"class":104},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":247,"slug":248,"hasResults":12,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":254,"minAge":19,"maxAge":255,"enrollmentInfo":256,"targetDuration":4,"studyType":24,"phases":258,"briefSummary":259,"conditions":260,"keywords":262,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":42},"100641400","physical-activity-and-cardiometabolic-health-in-women-with-or-without-polycystic-ovary-syndrome-scopap-100641400","NCT07659392","Physical Activity and Cardiometabolic Health in Women With or Without Polycystic Ovary Syndrome (SCOPAP)","Cardiometabolic Health in Women With Overweight or Obesity, With or Without Polycystic Ovary Syndrome: Effects of a Targeted Adapted Physical Activity Program","SCOPAP","Inclusion Criteria:\n\n* Women aged 18 to 40 years (inclusive boundaries)\n* Women with a body mass index (BMI) between 25 and 40 kg\u002Fm²\n* Women performing no more than 150 minutes of moderate-to-vigorous physical activity per week\n* Women able to provide informed consent to participate\n* Women affiliated with a social security system\n* One group will consist of women with polycystic ovary syndrome, and another group will consist of women without polycystic ovary syndrome\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding, as declared by the participant\n* Postmenopausal women\n* Women currently receiving pharmacological treatment for obesity or who have received such treatment within the past two years\n* Women under legal protection measures (guardianship, curatorship, or judicial protection)\n* Refusal to sign the informed consent form","FEMALE","40 Years",{"count":257,"type":23},40,[75],"The primary objective of this study is to investigate the effects of a multidisciplinary intervention, including a targeted adapted physical activity program, on lipid oxidation during a walking exercise in women with overweight or obesity, with or without polycystic ovary syndrome. Specifically, the study aims to compare changes in lipid oxidation before and after the intervention between women with polycystic ovary syndrome and those without polycystic ovary syndrome.\n\nThe secondary objectives are to assess the impact of polycystic ovary syndrome on several physiological and metabolic parameters in women with overweight or obesity. These include: (i) resting energy metabolism; (ii) resting blood pressure and heart rate; (iii) energy expenditure, energy cost, and heart rate during a walking exercise; (iv) body composition, glycemic and lipid profiles, and circulating levels of sex hormones and adipokines; (v) movement behaviors; and (vi) physical fitness.\n\nIn addition, the effect of the multidisciplinary intervention, including the adapted physical activity program, will be evaluated on these same outcomes: (i) resting energy metabolism; (ii) resting blood pressure and heart rate; (iii) energy expenditure, energy cost, and heart rate during walking exercise; (iv) body composition, glycemic and lipid profiles, and concentrations of sex hormones and adipokines; (v) movement behaviors; and (vi) physical fitness, in women with overweight or obesity, with or without polycystic ovary syndrome.",[261,29],"Poly Cystic Ovary Syndrome",[263,264,265,266],"polycystic ovary syndrome","women","cardiometabolic","Physical activity","2026-06-16",{"date":269,"type":34},"2026-06-22",{"date":271,"type":23},"2026-07",{"date":273,"type":23},"2028-12",{"name":275,"class":104},"University Hospital, Clermont-Ferrand",{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":283,"targetDuration":4,"studyType":24,"phases":285,"briefSummary":286,"conditions":287,"keywords":289,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":303,"leadSponsor":305,"locationsCount":42},"100641110","sucromet-nutritional-intervention-trial-100641110","NCT07656298","SucroMet Nutritional Intervention Trial","SucroMet' Nutritional Intervention: Study of the Metabolic Impact of Sucrose (Natural Sugar) and Sucralose (Artificial Sweetener) Intake at Different Doses and Modes of Consumption in Adults With Normal Weight, Overweight, and Obesity","Inclusion Criteria:\n\n* Adults aged 18 to 65 years at the time of enrollment.\n* Body Mass Index (BMI) between 18.5 and 39.9 kg\u002Fm².\n* Men and women who report a preference for sweet taste and habitual consumption of sugar and\u002For sweeteners.\n* Individuals in good general health, as determined by:\n\n  1. Medical history and clinical evaluation;\n  2. Absence of uncontrolled chronic diseases, such as diabetes, metabolic syndrome, severe hypertension, or advanced liver or renal disease; and\n  3. Baseline biochemical parameters within normal reference ranges, including fasting plasma glucose \\\u003C100 mg\u002FdL, HbA1c \\\u003C5.7%, normal liver and renal function (ALT\u002FAST and creatinine within reference ranges), and blood pressure \\\u003C140\u002F90 mmHg without pharmacological treatment.\n* Less than 4 hours per week of moderate-to-vigorous physical activity.\n* Not following special or restrictive diets (e.g., ketogenic, strict vegetarian, or vegan diets).\n* Not taking medications known to affect metabolism, including, for example, antidiabetic drugs, systemic corticosteroids, weight-loss medications, or high-dose antioxidant supplements, except for stable use of hormonal contraceptives.\n* Willingness to maintain habitual diet and physical activity throughout the study, with the only modification being the assigned sweetener intervention.\n* Ability and willingness to comply with all study procedures and scheduled visits.\n* Provision of written informed consent before participation.\n\nExclusion Criteria:\n\n* Gastrointestinal disorders influencing digestion or nutrient absorption (e.g., inflammatory bowel disease, celiac disease, malabsorption syndromes).\n* History of cancer not in remission.\n* Uncontrolled thyroid disorders.\n* History of bariatric surgery or extreme weight loss within the past 12 months.\n* Pregnancy, breastfeeding, or planning pregnancy during the study period.\n* Acute illness, major infection, hospitalization, or major surgery within the previous 6 months.\n* Any condition that, in the investigators' judgment, could compromise participant safety, protocol adherence, or interpretation of the study results.",{"count":284,"type":23},120,[75],"SucroMet is designed to evaluate how adding two commonly used sweeteners-sucrose (table sugar) and sucralose (a low-calorie sweetener)-at low and high doses may influence glucose regulation, including insulin resistance and fasting plasma glucose, in adults aged 18 to 65 years with normal weight, overweight, or obesity.\n\nThe low-dose intervention consists of 5% of the Estimated Energy Requirement (EER) from sucrose or 5 sucralose tablets per day (approximately 33.35 mg\u002Fday of sucralose). The high-dose intervention consists of 10% of EER from sucrose or 10 sucralose tablets per day (approximately 66.7 mg\u002Fday of sucralose). These doses maintain the planned 1:2 exposure ratio between the low- and high-dose intervention groups.\n\nBefore the intervention begins, participants' habitual dietary intake is assessed and, when necessary, minor dietary adjustments are made to support a stable overall eating pattern while maintaining energy intake. Participants then complete a four-week run-in period during which these recommendations are followed, and dietary records are used to verify dietary stability before the intervention starts.\n\nParticipants will consume the assigned sweetener incorporated into foods or beverages that they already consume as part of their habitual diet, without substantial changes to their usual eating patterns. The intervention includes two consecutive 12-week phases, one involving solid food intake and the other involving liquid intake, separated by a two-week washout period. This design allows evaluation of the effects of sweetener type, dose, and mode of consumption.\n\nThe primary outcomes are changes in glucose regulation, including fasting plasma glucose and insulin resistance assessed by HOMA-IR. Secondary outcomes include changes in body composition, anthropometric measurements, blood pressure, routine biochemical parameters, gut microbiota composition, DNA methylation patterns in peripheral blood cells, and biomarkers related to inflammation, oxidative stress, and metabolomic profiles measured in blood and urine.\n\nParticipants will attend scheduled study visits for anthropometric assessments, dietary evaluations, and biological sample collection. Blood, urine, and stool samples will be obtained at baseline and after each intervention phase.\n\nThe study aims to address the following questions:\n\n1. Do metabolic responses to sucrose and sucralose, including changes in insulin resistance (HOMA-IR) and fasting plasma glucose, differ according to participants' body mass index (BMI)?\n2. Do low and high doses of sucrose and sucralose differentially affect glucose regulation, body composition, and metabolic health?\n3. Does the mode of intake (solid versus liquid) influence changes in gut microbiota composition?\n4. Are changes in DNA methylation patterns in peripheral blood cells associated with the consumption of sucrose and sucralose at different doses and in different forms?\n5. Do different doses of sucrose and sucralose influence biomarkers related to inflammation, oxidative stress, and metabolomic profiles?",[29,288],"Glucose Metabolism",[290,291,292,293,288,294,295,296,297,298],"Sucrose","Sucralose","Sweeteners","Body Composition","Gut Microbiota","DNA Methylation","Inflammation","Oxidative Stress Biomarkers","Nutritional Intervention","2026-06-15",{"date":301,"type":34},"2026-06-18",{"date":271,"type":23},{"date":304,"type":23},"2027-09",{"name":306,"class":104},"Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud",{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":314,"enrollmentInfo":315,"targetDuration":4,"studyType":24,"phases":317,"briefSummary":318,"conditions":319,"keywords":320,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":328,"leadSponsor":330,"locationsCount":42},"100641904","effect-of-a-theory-based-multicomponent-ehealth-intervention-program-100641904","NCT07644143","Effect of A Theory-based Multicomponent eHealth Intervention Program","Effect Of A Theory-Based Multicomponent Ehealth Intervention On Weight Self - Stigma, Bodyweight And Quality Of Life Among Overweight And Obese Adults: A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged 18 to 55 years\n* Body mass index (BMI) ≥23 kg\u002Fm²\n* Weight self-stigma, defined as a Weight Self-Stigma Questionnaire (WSSQ) score \\>36\n* Owns or has regular access to a smartphone\n* Resides in Phan Dinh Phung municipality, Thai Nguyen Province, Vietnam\n* Able to read and write in Vietnamese\n\nExclusion Criteria:\n\n* Type 1 or type 2 diabetes\n* Uncontrolled hypertension, defined as blood pressure ≥160\u002F100 mmHg\n* Cardiovascular event, such as stroke or myocardial infarction, within the past year\n* Weight loss of ≥5% of initial body weight in the past 3 months or ≥10% in the past 2 years\n* Participation in a weight-loss program within the past 3 months\n* Cognitive impairment, including a diagnosis of dementia\n* Psychiatric condition, including major depression or generalized anxiety disorder\n* Current use of weight-loss medication\n* History of bariatric surgery\n* Unable to perform physical activity\n* Engages in ≥150 minutes of structured physical activity per week or \\>75 minutes of high-intensity exercise per week\n* Pregnant or planning pregnancy within the next 6 months","55 Years",{"count":316,"type":23},60,[75],"This study is a two-arm pilot randomized controlled trial designed to evaluate the feasibility and preliminary effects of an Acceptance and Commitment Therapy (ACT) theory-based mobile application integrated with a smartphone pedometer plus health education on weight self-stigma and lifestyle behaviors among overweight or obese adults.\n\nA total of 60 participants will be recruited and randomized 1:1 to the intervention (ACT-based app + pedometer + health education) or control condition. Outcomes will be assessed at baseline (T0), immediately after intervention (T1), and at 1 month after intervention (T2) and 3 months after intervention (T3) following intervention initiation. The primary outcomes are body weight (weight loss) and weight self-stigma measured; secondary outcomes include eating behavior, physical activity level, and quality of life.\n\nAnalyses will include per-protocol evaluation using linear mixed-effects models to test group, time, and group-by-time effects on primary and secondary outcomes, with intention-to-treat analyses conducted as sensitivity analyses using multiple imputation for missing weight and weight self-stigma data.\n\nFindings will inform the design of a future definitive trial and contribute evidence on eHealth approaches to reducing weight-related stigma and supporting healthier lifestyles.",[29],[321,322,88,87,323],"eHealth","Weight Self-Stigma","Quality of Life","2026-06-11",{"date":326,"type":34},"2026-06-12",{"date":219,"type":23},{"date":329,"type":23},"2026-12-15",{"name":331,"class":104},"Taipei Medical University",{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":71,"enrollmentInfo":339,"targetDuration":4,"studyType":24,"phases":341,"briefSummary":343,"conditions":344,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":42},"100635797","phase-1-a-study-of-srsd384-in-overweight-or-obese-participants-100635797","NCT07557355","A Study of SRSD384 in Overweight or Obese Participants","A Phase 1\u002F2a, Randomized, Double Blind, Placebo Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered SRSD384 in Overweight or Obese Participants","Inclusion Criteria:\n\n* Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions;\n* Males or females;\n* Body mass index (BMI) between 27.0 and 40.0 kg\u002Fm2, inclusive;\n* Male subjects are not allowed to donate sperm, and female subjects are not allowed to donate eggs from the time the ICF is signed until at least 3 months after the last follow-up.\n\nExclusion Criteria:\n\n* Obesity attributable, in the investigator's opinion, to medication use, endocrinologic or monogenic disorders;\n* Having a significant medical history or clinical manifestations related to any allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine (other than overweight or obesity), or psychiatric conditions that are severe or unstable (determined by the investigator or medically qualified designee);\n* Evidence of active cancer within 2 years prior to screening (non-melanoma skin cancer, localized prostate cancer treated with curative intent, or other in situ carcinoma that does not require systemic therapy and is considered cured for at least 1 year is allowed);\n* Acute febrile illness within 7 days prior to randomization or evidence of active infection\n* Any major surgery within 3 months prior to screening or plan to have any major surgery during the study;\n* History of clinically significant hypersensitivity, intolerance, or allergy to any oligonucleotide or GalNAc as determined by the investigator;\n* Receipt of an investigational drug within 30 days or 5 half-lives of that drug, whichever is longer, prior to dose administration in this study;\n* Have previously completed or withdrawn from this study or any other study investigating SRSD384 and have previously received SRSD384.",{"count":340,"type":23},78,[26,342],"PHASE2","This is a two-part study, intended to investigate the safety, tolerability, characteristics of PK and PD of single SC dose of SRSD384 alone in overweight or obese participants (Part A) and in combination with tirzepatide in overweight or obese participants with T2DM (Part B).",[29],"2026-06-03",{"date":347,"type":34},"2026-06-05",{"date":349,"type":23},"2026-06",{"date":351,"type":23},"2027-10",{"name":353,"class":41},"Sirius Therapeutics Co., Ltd.",{"id":355,"slug":356,"hasResults":12,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":361,"targetDuration":4,"studyType":24,"phases":363,"briefSummary":364,"conditions":365,"keywords":366,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":42},"100630415","phase-1-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-a-single-dose-of-ibio-600-in-overweight-or-obese-adults-100630415","NCT07487376","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of IBIO-600 in Overweight or Obese Adults","A Phase I, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBIO-600 in Overweight or Obese Adult Participants (IBIO-600-CT001).","Inclusion Criteria:\n\n* Aged 18 to 65 years of age\n* In good general health, with no significant medical history\n* BMI between ≥ 27.0 and ≤ 34.90 kg\u002Fm2\n* History of self-reported stable body weight (defined as change of no more or less than ± 5%) within 90 days of Screening.\n* Willingness to refrain from any reconstructive and\u002For cosmetic surgery and\u002For non-invasive cosmetic procedure that may affect body weight during the study\n* Must be fully ambulatory without any chronic orthopedic diseases or reliance on crutches, walkers, or a wheelchair that may preclude normal activity.\n* Be a nonsmoker\u002Fnonvaper and must not have used any nicotine or synthetic type products within 1 month prior to randomization.\n* Must not be pregnant or breastfeeding\n* Woman of childbearing potential (WOCBP) or fertile man agrees to use an acceptable method of contraception from the start of Screening until study completion, or for a minimum of 9 months following the last dose of IP, whichever period is longer.\n\nExclusion Criteria:\n\n* An underlying physical or psychological medical conditions that, in the opinion of the PI or medical designee, would make the participant unlikely to comply with the protocol or complete the study per protocol.\n* History or active diagnosis of diabetes (Type 1 or 2).\n* History of insulinoma or recurrent hypoglycemia (≥ 3 episodes in past 3 months).\n* History or presence of clinically significant muscle disease\n* History of or active cardiovascular disease including clinically significant arrhythmias, Class I-IV heart failure, coronary artery disease, thromboembolic event, or pulmonary hypertension.\n* Clinically significant laboratory abnormalities that would preclude participation in the study.\n* History of malignancy, except for non-melanoma skin cancer excised \\> 2 years ago or cervical intraepithelial neoplasia successfully treated \\> 5 years prior to randomization.\n* History or presence of any condition associated with significant immunosuppression.\n* History of substance abuse or dependency, or recreational IV drug use within the past 5 years (self-reported).",{"count":362,"type":23},32,[26],"The goal of this clinical trial is to learn which dose of study drug IBIO-600 has the right balance of safety, tolerability and impact on body composition in overweight and obese adult participants.",[29],[367,87,88,368,369,370],"iBio","Phase I","IBIO-600","Myostatin","2026-05-27",{"date":373,"type":34},"2026-05-29",{"date":375,"type":34},"2026-05-24",{"date":377,"type":23},"2027-05",{"name":379,"class":41},"iBio, Inc.",{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":24,"phases":389,"briefSummary":390,"conditions":391,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":404},"100621600","smartwatch-based-intervention-for-cardiovascular-health-switch-100621600","NCT07372729","Smartwatch-based Intervention for Cardiovascular Health (SWITCH)","A Smart Wearable Devices-based Comprehensive Intervention Through a Cluster Randomized Controlled Trial to Improve Cardiovascular Health in Overweight\u002FObese Individuals With Cardiometabolic Preconditions","Inclusion Criteria:\n\n1. Age \\>= 18 years, no gender restriction;\n2. Overweight and obesity: Body Mass Index (BMI) 24.0-32.4 kg\u002Fm\\^2, or waist circumference \\>= 90 cm for males and \\>= 85 cm for females;\n3. Presence of at least one metabolic high-risk state among prehypertension, prediabetes, or borderline elevated blood lipids, and without a diagnosis of hypertension, diabetes mellitus, or dyslipidemia:\n\n(1) Prehypertension: Systolic blood pressure (SBP) 130-139 mmHg and\u002For diastolic blood pressure (DBP) 80-89 mmHg, without regular use of antihypertensive medication in the past month; (2) Prediabetes: Fasting blood glucose (FBG) 6.1-6.9 mmol\u002FL, or glycated hemoglobin (HbA1c) 5.7%-6.4%, without regular use of hypoglycemic medication in the past month; (3) Borderline elevated blood lipids: Total cholesterol (TC) 5.2-6.1 mmol\u002FL, or low-density lipoprotein cholesterol (LDL-C) 3.4-4.0 mmol\u002FL, or triglycerides (TG) 1.7-2.2 mmol\u002FL, or non-high-density lipoprotein cholesterol (non-HDL-C) 4.1-4.8 mmol\u002FL, without regular use of lipid-lowering medication in the past month; 4. Local permanent residents who will reside in the area for at least 12 month after enrollment; 5. Have basic reading, writing, and comprehension abilities; proficient in using internet-connected smartphones; able to independently complete basic operations of the application; 6. Written informed consent provided.\n\nExclusion Criteria:\n\n1. Secondary obesity diagnosed by doctors in secondary or higher-level medical institutions;\n2. Cardiovascular and cerebrovascular diseases, including myocardial infarction, stroke, heart failure, arrhythmia; or having received coronary intervention therapy, cardiac surgery, etc.; or with a 10-year high risk of cardiovascular disease;\n3. Diseases seriously affecting survival, such as malignant tumors, AIDS, hepatic and renal failure;\n4. Pregnancy, lactation period, or women who may become pregnant within one year;\n5. History of severe neuropsychiatric diseases with potential cognitive or communication impairments, such as dementia, Alzheimer's disease, Parkinson's syndrome;\n6. Individuals with limited daily mobility;\n7. Individuals undergoing or planning to receive weight loss through surgery, medication, or other methods;\n8. Currently participating in other lifestyle intervention-related trials.",{"count":388,"type":23},1400,[75],"This study aims to employ a cluster randomized controlled trial to evaluate the effectiveness of an mHealth-Based Multi-faceted Cardiovascular Health Intervention Model among Overweight\u002FObese Individuals with Cardiometabolic Preconditions, thereby providing theoretical foundations and practical guidance for the prevention and management of this population.",[392,393,29,394],"Prehypertension","Borderline Dyslipidemia","Prediabetes","2026-05-12",{"date":397,"type":34},"2026-05-14",{"date":399,"type":34},"2026-03-24",{"date":401,"type":23},"2027-03-15",{"name":403,"class":104},"Beijing Anzhen Hospital",3,{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":12,"sex":254,"minAge":19,"maxAge":413,"enrollmentInfo":414,"targetDuration":4,"studyType":24,"phases":415,"briefSummary":416,"conditions":417,"keywords":420,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":42},"100636149","effects-of-high-frequency-left-dorsolateral-prefrontal-rtms-on-heart-brain-coupling-in-women-with-recurrent-pregnancy-loss-and-elevated-bmi-100636149","NCT07561931","Effects of High-frequency Left Dorsolateral Prefrontal rTMS on Heart-brain Coupling in Women With Recurrent Pregnancy Loss and Elevated BMI","Effects of High-frequency Left Dorsolateral Prefrontal rTMS on Heart-brain Coupling in Women With Recurrent Pregnancy Loss and Elevated BMI: a Randomized, Sham-controlled Mechanistic Trial (NEURO-CARD-BMI)","NEURO-CARD-BMI","Inclusion Criteria:\n\n* 1.Female participants aged 18-45 years and right-handed.\n* 2.Fulfillment of the prespecified definition of recurrent pregnancy loss in this study, defined as at least two consecutive spontaneous miscarriages occurring before 28 weeks of gestation.\n* 3.BMI ≥24 kg\u002Fm², classified as overweight or obesity according to the Chinese adult criteria for overweight and obesity.\n* 4.Currently not pregnant and in a clinically stable condition. If there is a recent history of missed abortion, appropriate management must have been completed and obstetric assessment must confirm the absence of acute vaginal bleeding, infection, marked abdominal pain, or hemodynamic instability.\n* 5.Ability to understand the study procedures, provide written informed consent, and cooperate with scale assessment, transcranial magnetic stimulation safety screening, and the single-session rTMS-ECG protocol.\n\nExclusion Criteria:\n\n* 1.Presence of contraindications to transcranial magnetic stimulation or elevated seizure risk, including but not limited to epilepsy or a history of unexplained seizures, intracranial ferromagnetic metal implantation, or the presence of electronic or metallic implanted devices within 30 cm of the coil that are judged unsuitable for transcranial magnetic stimulation.\n* 2.Current pregnancy.\n* 3.Hemodynamic instability or cardiovascular abnormalities that may substantially affect interpretation of the primary endpoint, including systolic blood pressure \\>180 mmHg or \\\u003C90 mmHg, atrial fibrillation or other clinically significant arrhythmias, valvular heart disease, marked sinus bradycardia, symptomatic coronary artery disease, or other cardiovascular conditions judged by the research team to make participation unsuitable.\n* 4.Uncontrolled major medical or neurologic disorders, particularly those that may substantially affect autonomic state, ECG recording, or interpretation of the primary endpoint, including uncontrolled thyroid dysfunction, uncontrolled diabetes mellitus, significant cerebrovascular disease, neurologic disorders, or active pulmonary disease.\n* 5.Presence of significant suicide risk.\n* 6.Severe psychiatric disorders that may affect study safety or adherence, including schizophrenia spectrum disorders, bipolar disorder during a manic or hypomanic episode, delirium, and active substance use disorder.\n* 7.Severe anxiety or severe depression, defined as a Hamilton Anxiety Rating Scale total score of ≥25 or a 17-item Hamilton Depression Rating Scale total score of ≥24.\n* 8.Recent medication-related confounding risk, including current withdrawal from alcohol, sedative-hypnotics, or other relevant substances, or initiation, discontinuation, or dose adjustment within the preceding 2 weeks of medications that may substantially affect seizure threshold, autonomic function, ECG-related indices, or interpretation of the primary endpoint.\n* 9.Any other condition judged by the research team to make participation inappropriate.","45 Years",{"count":316,"type":23},[75],"This randomized, sham-controlled mechanistic trial will examine whether a single session of high-frequency repetitive transcranial magnetic stimulation, rTMS, applied to the left dorsolateral prefrontal cortex can modify heart-brain coupling in women with recurrent pregnancy loss and elevated body mass index, BMI. Women with recurrent pregnancy loss often experience reproductive, metabolic, and emotional stress at the same time, and this combined vulnerability may be associated with altered autonomic regulation and exaggerated cardiac responses to stress. The left dorsolateral prefrontal cortex is a key brain region involved in cognitive control, emotion regulation, and top-down modulation of autonomic function.\n\nEligible participants will be randomly assigned in a 1:1 ratio to receive either real or sham rTMS at the same left dorsolateral prefrontal target. The stimulation protocol will use 10 Hz rTMS at 100% motor threshold, delivered in 30 cycles of 5 s stimulation followed by 11 s inter-train interval, with simultaneous 3-lead electrocardiography recording. The primary endpoint will be the between-group difference in mean heart-brain coupling across 30 stimulation cycles. Safety and tolerability will also be monitored. This study is intended to provide mechanistic evidence and methodological support for future multi-session randomized trials in this population.",[418,29,419],"Recurrent Pregnancy Loss","Heart-Brain Coupling",[421,422,423,424,425,426,427],"recurrent pregnancy loss","elevated BMI","overweight","heart-brain coupling","repetitive transcranial magnetic stimulation","left dorsolateral prefrontal cortex","autonomic regulation","2026-04-24",{"date":430,"type":34},"2026-05-01",{"date":432,"type":23},"2026-04-28",{"date":434,"type":23},"2026-09-30",{"name":436,"class":104},"Shenyang Medical College",{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":444,"enrollmentInfo":445,"targetDuration":4,"studyType":24,"phases":446,"briefSummary":447,"conditions":448,"keywords":450,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":459,"completionDateStruct":460,"leadSponsor":461,"locationsCount":42},"100627281","bfedbwell-inspire-pilot-100627281","NCT07446595","BfedBwell INSPIRE Pilot","BfedBwell INSPIRE: Impact of an Integrated Nutrition and Exercise Program for Post-treatment Survivors on Sleep Quality, Perceived Stress, and Biomarkers of Immune Dysregulation","Inclusion Criteria:\n\n* Age 18-75 years\n* BMI 25-45 kg\u002Fm2\n* History of cancer within the past 10 years with a diagnosis of an adulthood cancer of any type\n* In maintenance or surveillance status, defined as completion of active cancer therapy (e.g., surgery, radiation, chemotherapy, immunotherapy) with curative intent at least 3 months and no more than 10 years prior to enrollment or active surveillance with no treatment; ongoing targeted or hormone therapies ≥3 months prior to intervention start date and\u002For ongoing maintenance therapy ≥1 year is permitted (exceptions to this timeframe for completion of other therapies can be made on a case-by-case basis by the PI if patients are tolerating therapy without adverse effects and will have completed active treatment or been in stable maintenance treatment prior to the intervention start date)\n* Have a primary care provider (or are willing to establish care with a primary care provider prior to study enrollment) to address medical issues which may arise during screening or study procedures\u002Finterventions and who will provide clearance to participate in a nutrition and exercise program\n* Ability and willingness to participate in a supervised exercise program; with ability assessed by the Physical Activity Readiness Questionnaire (PAR-Q+) and questions based upon National Comprehensive Cancer Network (NCCN) guidelines (note: any positive responses will trigger a required physician clearance form)\n* Speak English\n* Have access to a computer or smart phone and Internet to join Zoom meetings, complete questionnaires, and access\u002Fdownload the True Coach virtual exercise coaching sessions\n* Live or work within 30 miles of the AHWC (exceptions may be made at the discretion of the study PI on a case-by-case basis for highly motivated subjects)\n* Not be planning for major elective surgery, to travel for \\>2 consecutive weeks, or relocate\u002Fmove during the intervention (\\~6 months)\n* No nicotine or tobacco use within previous 6 months\n* Agree to refrain from use of all nutritional supplements aside from those prescribed by a physician for the duration of the study\n* Capable and willing to give informed consent and understand exclusion criteria\n* Willing to attend weekly small group education sessions, monthly behavioral skills development sessions, weekly group support sessions, and monthly 1:1 counseling sessions with a registered dietitian (RD)\n* Willing to attend up to two BfitBwell exercise sessions (one in person supervised, one virtual unsupervised) per week for first 12 weeks then once monthly supervised and once weekly unsupervised virtual sessions for second 12 weeks\n* Not meeting dietary guidelines \\[i.e., Healthy Eating Index (HEI) score \\\u003C80 as assessed via NCI DHQ III food frequency questionnaire\\] or physical activity guidelines \\[i.e., \\\u003C150 minutes moderate\u002Fvigorous activity per week via self-report on Godin-Shephard Leisure-Time Physical Activity Questionnaire\\] (exceptions may be made at the discretion of the study PI on a case-by-case basis for highly motivated subjects)\n\nExclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 2 or higher\n* Actively undergoing chemotherapy, radiation, immunotherapy with curative intent or within 3 months of completion of surgery, chemotherapy, or radiation treatment or recent initiation of targeted\u002Fhormonal therapy (\\\u003C3 months) or maintenance therapy (\\\u003C1 year) unless well-tolerated and deemed acceptable by PI on a case-by-case basis\n* Greater than 10 years post-active or maintenance therapy\n* Plans to relocate within the next 6 months\n* Plans for extended travel (\\>2 weeks) within the next 6 months\n* For females: (1) Currently pregnant or lactating, (2) Pregnant within the past 6 months, (3) Planning to become pregnant in the next 18 months; sexually active women of childbearing potential may be enrolled if they have had a tubal ligation or use a reliable means of contraception\n* Any major surgery within the past 3 months or planned elective surgery during the intervention period, including mastectomy\n* Have completed treatment that significantly impacts digestion, metabolism, and\u002For food intake (e.g., surgical loss of esophagus, stomach, colon)\n* Recent (past 6 months) acute coronary event, unstable angina, coronary revascularization, stroke, or pulmonary embolism\n* Symptoms suggestive of cardiovascular disease (e.g., chest pain, shortness of breath at rest or with mild exertion, lightheadedness, syncope)\n* Uncontrolled hypertension, defined as diastolic blood pressure \\>100 mmHg, systolic blood pressure \\>160 mmHg, or resting heart rate \\>100 bpm as measured in duplicate on the screening visit after 5 minutes of rest in a seated position (if screening is needed due to lack of updated medical record within previous 12 months)\n* Diabetes (history of type 1 or type 2 diabetes, hemoglobin A1c ≥6.5%, or fasting glucose ≥126 mg\u002FdL as measured during the screening visit if screening is needed due to lack of updated medical record within previous 12 months) unless well controlled on metformin or DPP-V inhibitor monotherapy with hemoglobin A1c \\\u003C8%\n* History of uncontrolled thyroid disorder. History of thyroid disease or current thyroid disease treated with a stable medication regimen is acceptable\n* Triglycerides \\>500 mg\u002FdL as measured on the screening visit (if screening is needed due to lack of updated medical record within previous 12 months)\n* LDL cholesterol \\>200 mg\u002FdL as measured on the screening visit (if screening is needed due to lack of updated medical record within previous 12 months)\n* Presence or history of other metabolic or chronic health problems which would impact ability to safely participate in a weight loss intervention involving diet and exercise: significant cardiac arrhythmias or cardiac valvular disease, significant gastrointestinal, pulmonary, renal, musculoskeletal, neurologic, hematologic, or psychiatric disease\n* Have started lipid-lowering, hypertension, or oral hypoglycemic medication in previous 3 months\n* Sustained use of prescription or over-the-counter medications known to significantly impact appetite, weight, or energy metabolism (e.g., obesity pharmacotherapeutics agents, appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants) with the exception of anti-endocrine or Her2 directed treatment for breast cancer and standard of care anti-emetic or anti-diarrheal agents.\n* Sustained use of systemic glucocorticoids (current or in the past 6 months) unless physiologic replacement therapy for adrenal insufficiency\n* Previous obesity treatment with surgery or weight loss device, except: (1) liposuction and\u002For abdominoplasty if performed \\>1 year before screening, (2) lap banding if the band has been removed \\>1 year before screening, (3) intragastric balloon if the balloon has been removed \\>1 year before screening, (4) duodenal-jejunal bypass sleeve if the sleeve has been removed \\>1 year before screening, or (5) AspireAssist or other endoscopically placed weight loss device if the device has been removed \\>1 year before screening\n* Participation within previous 6 months, current participation in, or planning to participate in any formal nutrition, weight loss, or physical activity programs or clinical trials over the next 6 months\n* Previous participation the BfitBwell exercise oncology program within the previous 3 years (exceptions may be made at the discretion of the study PI)\n* Nicotine or tobacco use (current or past 6 months)\n* Current alcohol or substance abuse as assessed by the Cut down, Annoyed, Guilty, and Eye-Opener (CAGE) questionnaire (note: study PI will follow up if screener raises any concerns of substance abuse to determine final eligibility)\n* History of clinically diagnosed eating disorders including anorexia nervosa, bulimia, binge eating disorder. Score \\>20 on the Eating Attitudes Test (EATS-26) or pattern of response on the Questionnaire of Eating and Weight Patterns (QEWP-5) suggestive of possible binge eating disorder or bulimia will require further assessment by the study MD to determine if it is appropriate for the subject to participate in the study\n* Current severe depression or history of severe depression within the previous year, based on Center for Epidemiologic Studies Depression Scale (CES-D) which in the opinion of the study MD would interfere with ability to adhere to the diet and exercise interventions and provide feedback on the interventions via questionnaires and focus groups\n* History of other significant psychiatric illness (e.g., psychosis, schizophrenia, mania, bipolar disorder) which in the opinion of the study MD would interfere with ability to adhere to the diet and exercise interventions and provide feedback on the interventions via questionnaires and focus groups\n* Have medical or physical limitations or contraindications to engaging in physical activity (e.g., severe orthopedic conditions, paralysis) or are considered high-risk based on ACSM guidelines\n* Are cognitively unable to consent","75 Years",{"count":7,"type":23},[75],"This single-arm pilot study will evaluate the feasibility and acceptability of a comprehensive survivorship lifestyle intervention addressing nutrition, exercise, sleep health, and stress management. The intervention integrates the BfedBwell survivorship nutrition program with the BfitBwell clinical exercise oncology program. The augmented BfedBwell program includes: (1) a core education curriculum, (2) 1:1 counseling with a registered dietitian, (3) behavioral skills development, (4) group support, and (5) commercially available wearable technology and smart scales for self-monitoring of physical activity, sleep, and body weight.",[449,29],"Cancer Survivorship",[451,452,453,454,455,456],"Adult Cancer Survivor","Lifestyle Behavior","Diet, food, and nutrition","Exercise","Sleep","Stress","2026-04-22",{"date":432,"type":34},{"date":349,"type":23},{"date":134,"type":23},{"name":462,"class":104},"University of Colorado, Denver",{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":444,"enrollmentInfo":470,"targetDuration":4,"studyType":24,"phases":471,"briefSummary":472,"conditions":473,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":404},"100627009","phase-1-a-study-of-zovaglutide-zt002-injection-in-participants-with-impaired-kidney-function-and-healthy-participants-100627009","NCT07443059","A Study of Zovaglutide (ZT002 Injection) in Participants With Impaired Kidney Function and Healthy Participants","A Phase I Clinical Study to Evaluate the Pharmacokinetic Characteristics and Safety of Single-dose of Zovaglutide (ZT002 Injection) in Participants With Different Degrees of Renal Insufficiency and Matched Participants With Normal Renal Function","Inclusion Criteria:\n\n1. Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;\n2. Male or female, age between 18 - 75 years (both inclusive) at the time of signing of the informed consent.\n3. Body mass index (BMI) 19.0 - 32.0 kg\u002Fm²(both inclusive). Body weight ≥50 kg for male participants and ≥45 kg for female participants.\n4. Diagnosed as stable, chronic renal disease for at least 3 months.\n5. Renal function, assessed by estimated glomerular filtration rate at screening (eGFR):\n\n   Normal renal function: 90-129 mL\u002Fmin (inclusive); Mild impairment: 60-89 mL\u002Fmin (inclusive); Moderate impairment: 30-59 mL\u002Fmin (inclusive); Severe impairment: 15-29 mL\u002Fmin (inclusive);\n6. Stable renal function, assessed by two eGFR during screening.\n\nExclusion Criteria:\n\n* All participants will not be included in this study if they meet any of the following criteria:\n\n  1. History of acute or chronic pancreatitis, or pancreatic injury.\n  2. History of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia (MEN2) in personal or family history.\n  3. History of depression\u002Fanxiety disorder, or prior diagnosis of moderate-to-severe anxiety\u002Fdepressive state, or history of severe psychiatric disorders;\n  4. Those with any type of treated or untreated malignancy (whether cured or not) within 5 years before screening or during the baseline period (except basal cell carcinoma of the skin)\n  5. Those with any type of malignant tumors within 5 years prior to screening (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).\n\n     Participants in the renal insufficiency group will not be included in this study if they meet any of the following criteria:\n  6. Those with obstructive uropathy (e.g., urinary tract obstruction due to calculi or space-occupying lesions) or renal impairment caused by other etiologies unrelated to intrinsic renal dysfunction (e.g., renal tumors) and\u002For renal diseases (e.g., renal artery stenosis, nephrotoxic drugs, severe infections, hypovolemia, heart failure, etc.), and deemed by the investigator as unsuitable for participation in this clinical trial.\n  7. Those with systolic blood pressure exceeding 160 mmHg or diastolic blood pressure exceeding 100 mmHg in the screening period;\n  8. Those who have received any medications known to alter renal tubular creatinine secretion (e.g., cimetidine, trimethoprim, or cibenzoline, or salicylates excluding topical formulations), competitive inhibitors of renal tubular secretion (e.g., probenecid), or nephrotoxic drugs (e.g., non-steroidal anti-inflammatory drugs, polymyxins, vancomycin) within 14 days prior to screening or 5 half-lives (whichever is longer).\n\n     Participants in the normal renal function group will not be included in this study if they meet any of the following criteria:\n  9. Those who have suffered from diseases of other systems, such as the cardiovascular, respiratory, digestive, endocrine, hematologic, or neuropsychiatric systems, within 1 year prior to screening, and are considered by the investigator to be unsuitable for participation in this study.\n  10. Those with systolic blood pressure exceeding 90-140 mmHg (including both end values) or diastolic blood pressure exceeding 50-90 mmHg (including both end values)\n  11. Use of any medication, including prescription drugs, over-the-counter medication, Chinese herbal medicines, and dietary supplements (e.g., vitamins and minerals that may affect study outcomes) within 14 days or 5 half-lives (whichever is longer) prior to screening;",{"count":257,"type":23},[26],"This study is a single-dose, open-label, parallel design phase I clinical study to evaluate the PK characteristics and safety of single subcutaneous injection of ZT002 Injection in participants with different degrees of renal insufficiency and matched participants with normal renal function.",[29],"2026-04-15",{"date":476,"type":34},"2026-04-20",{"date":478,"type":34},"2026-04-13",{"date":480,"type":23},"2027-03-19",{"name":482,"class":41},"Beijing QL Biopharmaceutical Co.,Ltd",{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":18,"minAge":70,"maxAge":207,"enrollmentInfo":490,"targetDuration":4,"studyType":24,"phases":492,"briefSummary":493,"conditions":494,"keywords":499,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":4},"100634103","exercise-targeted-smart-lifestyle-management-100634103","NCT07535333","Exercise-Targeted Smart Lifestyle Management","Study on the Improvement Effects of Intelligent Lifestyle Management, Targeting Exercise Capacity Enhancement, on Overweight\u002FObesity With Metabolic Syndrome","Inclusion Criteria:\n\n* Aged between 20 and 60 years.\n* Overweight or obese, with a Body Mass Index (BMI) ≥ 24 kg\u002Fm² and \\\u003C 40 kg\u002Fm².\n* Patients with impaired metabolic parameters regarding glucose, lipids, and blood pressure，meet at least two of the following criteria:\n\n  * Central obesity: Waist circumference ≥ 90 cm for males or ≥ 85 cm for females.\n  * Hyperglycemia: Fasting plasma glucose (FPG) ≥ 6.1 mmol\u002FL, or 2-hour plasma glucose ≥ 7.8 mmol\u002FL during an oral glucose tolerance test (OGTT), and\u002For currently receiving treatment for previously diagnosed diabetes.\n  * Hypertension: Blood pressure ≥ 130\u002F85 mmHg, and\u002For currently receiving treatment for previously diagnosed hypertension.\n  * Elevated fasting triglycerides (TG): ≥ 1.7 mmol\u002FL.\n  * Reduced fasting high-density lipoprotein cholesterol (HDL-C): \\\u003C 1.04 mmol\u002FL.\n\nExclusion Criteria:\n\n* History of cardiovascular or cerebrovascular disease, or in the acute phase, including: angina pectoris, myocardial infarction, coronary revascularization surgery, stroke (ischemic or hemorrhagic, including transient ischemic attack), symptomatic peripheral artery disease requiring surgery or diagnosed via angiographic techniques, ventricular arrhythmias, uncontrolled atrial fibrillation, congestive heart failure (New York Heart Association class III or IV), hypertrophic cardiomyopathy, history of aneurysm with diameter ≥ 5.5 cm, or history of aneurysm surgery.\n* Malignancy or history of malignancy within the past five years.\n* Religious restrictions or dysphagia preventing adherence to the recommended diet.\n* Contraindications to exercise, such as orthopedic disorders.\n* Participation in other weight-loss programs (\\> 5 kg weight loss) within the six months prior to the screening visit.\n* History of bariatric surgery or intention to undergo bariatric surgery within the next 12 months.\n* History of small or large bowel resection or inflammatory bowel disease.\n* Obesity due to endocrine disorders of unknown cause (excluding treated hypothyroidism).\n* Allergy to any food components of the Mediterranean diet.\n* Immunodeficiency or HIV positive status.\n* Cirrhosis or liver failure.\n* Severe psychiatric disorders, including schizophrenia, bipolar disorder, eating disorders, or depression requiring hospitalization in the past 6 months.\n\nSevere comorbidities with a life expectancy of less than 24 months.\n\n* Alcoholism, addiction, or drug abuse in the past six months (or daily alcohol consumption \\> 50 g).\n* History of major organ transplantation.\n* Concomitant use of immunosuppressive or cytotoxic medications.\n* Current use of systemic corticosteroids.\n* Current use of weight-loss medications.\n* Currently participating in another randomized clinical trial.\n* Patients with acute infection or inflammation (e.g., pneumonia) may -participate 3 months after resolution of the condition.\n* Pregnant or planning to become pregnant during the study period.\n* Any other condition that may interfere with protocol compliance.\n* Refusal to sign the informed consent document.",{"count":491,"type":23},435,[75],"To investigate the effects of simple dietary management and diet combined with exercise capacity-targeted intelligent lifestyle management on improving metabolic indicators in patients with overweight\u002Fobesity and metabolic syndrome.",[495,496,497,498,29],"M-health","Metabolic Syndrome","Lifestyle Alteration","Lifestyle (Sedentary Behavior and Physical Activity)",[500,496,501,502,29],"mhealth","Lifestyle (sedentary behavior and physical activity)","Mediterranean Diet","2026-04-09",{"date":505,"type":34},"2026-04-17",{"date":507,"type":23},"2026-05",{"date":509,"type":23},"2027-06",{"name":511,"class":512},"China National Center for Cardiovascular Diseases","OTHER_GOV",{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":519,"eligibilityCriteria":520,"healthyVolunteers":17,"sex":18,"minAge":521,"maxAge":522,"enrollmentInfo":523,"targetDuration":4,"studyType":24,"phases":524,"briefSummary":525,"conditions":526,"keywords":534,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":548},"100616125","effectiveness-of-a-10-week-multicomponent-intervention-combined-with-parent-education-on-binge-eating-behavior-in-children-and-adolescents-100616125","NCT07301541","Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents","Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents: a Randomized Controlled Trial With Long-term Follow-up","STOB","Inclusion Criteria:\n\n* Attending the camp in Hobro or Fjordmark from January 2027 to December 2027\n* 7-14 years of age at recruitment\n* Participants must have written informed consent from parent\u002Fguardian before camp to participate\n* At least one parent\u002Fguardian submit written informed consent to participate in the study with their child\n\nExclusion Criteria:\n\n* A medical condition affecting dietary intake and\u002For eating behavior\n* Taking weight loss medication\n* The parent\u002Fguardian don't understand the written informed consent\n* Participant or parent\u002Fguardian are unwilling to or unable to comply with the study protocol and instructions given by the study staff.","7 Years","14 Years",{"count":209,"type":23},[75],"The main purpose is to investigate the effectiveness of a 10-week multicomponent camp intervention to reduce BE behavior in children and adolescents and explore in a randomized controlled setting if a parent-based BED-intervention has any add-on effect, attenuating the development of BE behavior in this sample. The study will include an initial follow-up assessment scheduled 10-12 weeks after camp completion and plans for long-term follow-up assessments one, three and five years after inclusion.\n\nOverall, we hypothesize that the multicomponent camp intervention will effectively reduce BE behavior in children and adolescents. Furthermore, we hypothesize that participants whose parents are randomized to receive the parental BED intervention will show a lower prevalence of BE behavior one year after the camp intervention compared with children whose parents receive standard care.",[527,528,529,29,530,531,532,533],"Binge Eating Disorder","Binge Eating","Loss of Control Eating","Children","Childhood Obesity","Screening","BED",[535,536,537,530,538,539,533,532],"Binge eating","Binge eating disorder","Lifestyle intervention","Loss of control eating","Adolescents","2026-04-07",{"date":478,"type":34},{"date":543,"type":23},"2027-01",{"date":545,"type":23},"2036-01",{"name":547,"class":104},"University of Aarhus",2,{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":555,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":557,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":559,"conditions":560,"keywords":561,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":574},"100631706","real-world-effectiveness-and-dosing-patterns-of-tirzepatide-in-people-with-obesity-100631706","NCT07504172","Real-world Effectiveness and Dosing Patterns of Tirzepatide in People With Obesity","Real-world Effectiveness and Dosing Patterns of Tirzepatide: A Multicentre Retrospective Observational Study in the Netherlands","TIRZ-DOSE-NL","Inclusion Criteria:\n\n* Adults (age ≥18 years old)\n* A BMI of ≥ 30 kg\u002Fm2 or a BMI ≥ 27 kg\u002Fm2 with at least one obesity complication (e.g., hypertension, dyslipidaemia)\n\nExclusion Criteria:\n\n* Pregnant women or pregnancy during treatment\n* Previously treated for obesity (with pharmacotherapy, endoscopic treatment or metabolic-bariatric surgery)\n* Patients with diabetes",{"count":558,"type":23},1700,"Tirzepatide is one of the new medications for the treatment of obesity. In clinical research people treated with Tirzepatide have weight loss up to 21%. But there is only a little bit of research showing the effect of Tirzepatide in clinical practice.\n\nIn this retrospective observational study the investigators will evaluate the effectiveness of tirzepatide in routine clinical practice among adults with obesity in the Netherlands.The main questions it aims to answer are:\n\n* How much weight do patients lose after six months of treatment with tirzepatide combined with lifestyle coaching?\n* How is the medication dosed in daily practice? Researchers will use data from electronic health records of patients in multiple outpatient locations of the Dutch Obesity Clinic (NOK, Nederlandse Obesitas Kliniek).",[29,118],[88,562,563,82,154,564],"Weightloss","Tirzepatide","Dose escalation","2026-03-25",{"date":567,"type":34},"2026-03-31",{"date":569,"type":23},"2026-04-01",{"date":571,"type":23},"2026-08-01",{"name":573,"class":104},"Radboud University Medical Center",10,{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":581,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":18,"minAge":583,"maxAge":522,"enrollmentInfo":584,"targetDuration":4,"studyType":24,"phases":586,"briefSummary":587,"conditions":588,"keywords":591,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":600,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":42},"100619302","comparing-outcomes-among-children-with-obesity-in-a-community-healthy-lifestyle-program-100619302","NCT07342855","Comparing Outcomes Among Children With Obesity in a Community Healthy Lifestyle Program","Comparison Study to Evaluate the Outcomes Among Children Participating in a Community Healthy Lifestyle Program","73357","Inclusion Criteria:\n\n* BMI by report of ≥ 85th percentile\n* The child must be able to participate in physical activity comparable to an elementary school PE class and must be able to function cognitively at or above the level of a 6 year old\n\nExclusion Criteria:\n\n* BMI by report of below the 85th percentile\n* Inability to participate in physical activity comparable to an elementary school PE class and must be able to function cognitively at or above the level of a 6 year old\n\nParent will be invited but not required to be weighed and measured.","6 Years",{"count":585,"type":23},160,[75],"This study aims to evaluate the outcomes of an existing clinical program that teaches families of children with overweight and obesity healthy lifestyle. The design will be unblinded, randomized, waitlist control.",[589,590,29],"Pediatric Obesity","Pediatric Overweight",[88,592,593,594,595,596,597,598,599],"FNPA","BAQ","Endurance","%BMIp95","Family Healthy Weight Program","Community Healthy Lifestyle Program","intensive health behavior and lifestyle treatment","PACER",{"date":601,"type":34},"2026-03-30",{"date":603,"type":34},"2026-01-15",{"date":605,"type":23},"2027-06-30",{"name":607,"class":104},"University of Texas Southwestern Medical Center",{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":613,"acronym":4,"eligibilityCriteria":614,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":444,"enrollmentInfo":615,"targetDuration":4,"studyType":24,"phases":617,"briefSummary":619,"conditions":620,"keywords":624,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":634,"completionDateStruct":635,"leadSponsor":637,"locationsCount":42},"100630291","phase-4-metformin-combined-with-secukinumab-for-moderate-to-severe-plaque-psoriasis-in-overweight-or-obese-chinese-patients-100630291","NCT07485764","Metformin Combined With Secukinumab for Moderate-to-Severe Plaque Psoriasis in Overweight or Obese Chinese Patients","A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Metformin in Combination With Secukinumab for the Treatment of Moderate-to-Severe Plaque Psoriasis in Overweight or Obese Chinese Patients","Inclusion Criteria:\n\n1. Subjects voluntarily participate in the study and sign the informed consent form.\n2. Aged 18-75 years (inclusive) at the time of signing informed consent, male or female.\n3. Diagnosed with chronic plaque psoriasis for \\>=6 months prior to the first study drug administration.\n4. Overweight\u002Fobesity: Body mass index (BMI) \\>=25 kg\u002Fm².\n5. Moderate-to-severe plaque psoriasis (defined as):\n\n   Psoriasis Area and Severity Index (PASI) score \\>=12 at screening and prior to first dose.\n\n   Investigator's Global Assessment (IGA) score \\>=3 at screening and prior to first dose.\n\n   Stable disease within 2 months prior to randomization.\n6. Deemed candidates for phototherapy or systemic therapy by the investigator, defined as subjects with moderate-to-severe chronic plaque psoriasis uncontrolled by:\n\n   Topical therapy and\u002For phototherapy and\u002For prior systemic therapy.\n7. Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study medication (Day 0). Both women of childbearing potential and male patients with reproductive capacity must agree to use highly effective contraceptive methods during the study and for 15 weeks following the last dose.\n8. Lactating women agree to discontinue breastfeeding during the study and for 15 weeks following the last dose of study medication.\n9. Subjects must be capable of effective communication with investigators and adhere to the clinical trial protocol to complete all study requirements. -\n\nExclusion Criteria:\n\n* 1: BMI \\\u003C25 kg\u002Fm². 2: Presence of guttate, pustular, or erythrodermic psoriasis, or other diseases that may confound treatment outcomes (e.g., cutaneous lesions, systemic autoimmune diseases).\n\n  3: Drug-induced psoriasis (e.g., new-onset or exacerbated psoriasis caused by beta-blockers, calcium channel blockers, or lithium).\n\n  4: Use of prohibited medications: Systemic non-biologic agents (e.g., glucocorticoids, leflunomide, methotrexate, cyclosporine, retinoids, azathioprine, mycophenolate mofetil, traditional Chinese medicines for psoriasis) within 4 weeks prior to screening.\n\nEtanercept or its biosimilars within 4 weeks prior to screening; TNF-α inhibitors or their biosimilars within 12 weeks prior to screening.\n\nOther biologic agents for psoriasis (e.g., IL-12\u002F23 or IL-23 inhibitors) within 5 half-lives of the drug prior to screening.\n\n5: Prior use of secukinumab or other IL-17A\u002FIL-17R-targeted biologic agents within 12 weeks prior to screening.\n\n6: History of malignancy within the past 5 years (e.g., cutaneous squamous cell carcinoma, basal cell carcinoma, cervical carcinoma in situ).\n\n7: Active inflammatory diseases other than psoriasis that may confound the evaluation of secukinumab efficacy.\n\n8: Metabolic or inflammatory diseases (e.g., type 2 diabetes) that may confound the evaluation of metformin efficacy.\n\n9: History of lymphoproliferative disorders (e.g., lymphoma, lymphadenopathy) or splenomegaly.\n\n10: Opportunistic infections within 6 months prior to screening (e.g., herpes zoster, CMV, Mycoplasma, Pneumocystis jirovecii, histoplasmosis, candidiasis, aspergillosis, NTM).\n\n11: Chronic or recurrent infectious diseases (e.g., chronic hepatitis, pyelonephritis) or severe\u002Flife-threatening infections within 6 months prior to screening; current signs\u002Fsymptoms suggestive of infection (e.g., fever, cough, dysuria, abdominal pain, diarrhea, infected skin wounds).\n\n12: High risk of infection (e.g., leg ulcers, indwelling urinary catheters, recurrent chest infections, bedridden\u002Fwheelchair-bound status).\n\n13: Major surgery within 8 weeks prior to screening or planned during the study, deemed to pose unacceptable risk by the investigator.\n\n14: Live virus\u002Fbacterial vaccines (e.g., BCG) within 6 weeks prior to screening or planned during the study\u002Fwithin 15 weeks after last dose.\n\n15: Participation in another clinical trial within 4 weeks prior to screening or within 5 half-lives of the investigational product (whichever is longer).\n\n16: Laboratory abnormalities: Hemoglobin \\\u003C8.5 g\u002FdL WBC \\\u003C2,500\u002FμL ANC \\\u003C1,500\u002FμL Platelets \\\u003C100,000\u002FμL ALT\u002FAST \\>2×ULN Creatinine \\>176.8 μmol\u002FL (2.0 mg\u002FdL) 17: Active hepatitis B (positive HBsAg). 18: Positive HCV antibody. 19: HIV infection or positive HIV antibody. 20: Syphilis infection. 21: Active or latent tuberculosis at screening. 22: Hypersensitivity to trial drug excipients, murine\u002Fhuman proteins, or immunoglobulin products.\n\n23: Inability to communicate\u002Fcomply (e.g., psychiatric disorders, frequent travel, lack of motivation).\n\n24: Other conditions deemed by the investigator to compromise study participation.",{"count":616,"type":23},186,[618],"PHASE4","This is a randomized, double-blind, placebo-controlled, multicenter clinical trial conducted in China. The study aims to evaluate the efficacy and safety of metformin combined with secukinumab in the treatment of moderate-to-severe plaque psoriasis in overweight or obese Chinese patients.\n\nA total of approximately 186 participants will be enrolled and randomly assigned in a 1:1 ratio to receive either secukinumab plus metformin or secukinumab plus placebo. The study consists of a screening period, an induction period, a maintenance period, and a follow-up period, with a total duration of 60 weeks.\n\nThe primary endpoints are the proportions of participants achieving PASI75 (≥75% improvement in Psoriasis Area and Severity Index) and an IGA score of 0 or 1 (clear or almost clear) at Week 24. Secondary endpoints include PASI90, quality of life (DLQI), pruritus NRS score, metabolic parameters, and safety assessments.\n\nThis study aims to provide a more effective combination therapy for psoriasis patients with overweight or obesity.",[621,622,623,29],"Psoriasis","Plaque Psoriasis","Moderate-to-severe Plaque Psoriasis",[625,626,627,628,629,630,631],"Metformin","Secukinumab","IL-17 Inhibitor","Randomized Controlled Trial","Double-Blind","Placebo-Controlled","Chinese Patients","2026-03-22",{"date":565,"type":34},{"date":349,"type":23},{"date":636,"type":23},"2029-06",{"name":638,"class":104},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":640,"slug":641,"hasResults":12,"nctId":642,"briefTitle":643,"officialTitle":644,"acronym":645,"eligibilityCriteria":646,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":647,"enrollmentInfo":648,"targetDuration":4,"studyType":24,"phases":650,"briefSummary":651,"conditions":652,"keywords":655,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":662,"lastUpdatePostDateStruct":663,"startDateStruct":665,"completionDateStruct":667,"leadSponsor":668,"locationsCount":42},"100627197","high-phenolic-olive-oil-for-enhancing-metabolic-health-a-randomized-controlled-trial-in-patients-with-central-obesity-hope-100627197","NCT07445503","High Phenolic Olive Oil for Enhancing Metabolic Health: a Randomized-controlled Trial in Patients With cEntral Obesity (HOPE)","High Phenolic Olive Oil for Enhancing Metabolic Health: a Randomized-controlled Trial in Patients With Central Obesity","HOPE","Inclusion Criteria:\n\n* Adult men and women 18-80 years of age,\n* Overweight\u002Fobesity (body mass index \\> 25 or waist circumference \\>94 cm for males and \\>80 cm for females), and\n* The presence of at least one of the following metabolic abnormality: (1) triglyceride level ≥150 mg\u002FdL or HDL cholesterol ≤40 mg\u002FdL in men and ≤50 mg\u002FdL in women; (2) increased blood pressure ≥ 130\u002F85 mm Hg; (3) elevated fasting blood sugar ≥100 mg\u002FdL; (4) standardized drug treatment regimen, and\n* Provided signed informed consent for participation.\n\nExclusion Criteria:\n\n* Concomitant acute or chronic disease (e.g., infection, cancer, chronic heart failure, kidney disease, autoimmune diseases like rheumatoid arthritis, inflammatory bowel diseases, Hashimoto),\n* Untreated diabetes,\n* Women at pregnancy or lactation,\n* Individuals with psychiatric or mental disorder,\n* Any use of antioxidant-phytochemical rich supplement, anti-, pre- or probiotics pre-intervention,\n* Drug and\u002For alcohol abuse,\n* Those who did not consent or were unable to provide consent.","80 Years",{"count":649,"type":23},80,[75],"Olive oil is a fundamental component of the Mediterranean diet and a major source of monounsaturated fatty acids with well-established cardioprotective properties. When rich in phenolic compounds-such as hydroxytyrosol, tyrosol, oleuropein, oleocanthal, oleacein, and ligstroside aglycone-it is considered a functional food with antioxidant, anti-inflammatory, cardioprotective, chemoprotective, and neuroprotective effects. According to EU Regulation 432\u002F2012, daily consumption of 20 g of extra virgin olive oil containing at least 5 mg of hydroxytyrosol and tyrosol derivatives (250 mg\u002Fkg) contributes to the protection of blood lipids from oxidative stress and qualifies for a health claim.\n\nOverweight\u002Fobesity, characterized by excessive fat accumulation, is strongly associated with non-communicable diseases, including cardiovascular disease, type 2 diabetes, hypertension, certain cancers, and neurodegenerative disorders. Chronic low-grade inflammation and oxidative stress are key mechanisms underlying obesity-related metabolic disorders. Although dietary energy restriction remains the primary approach for weight management, growing research interest focuses on natural products rich in phenolic compounds as potential modulators of molecular pathways involved in central obesity.\n\nHowever, robust clinical evidence in humans with central obesity and metabolic abnormalities remains limited. Therefore, this double-blind, randomized, controlled trial aims to investigate the effects of extra virgin, high-phenolic olive oil (HPOO) compared with low-phenolic olive oil (LPOO) in adults with overweight\u002Fobesity with metabolic abnormalities. Participants will consume the assigned olive oil type (HPOO or LPOO) for eight weeks.\n\nAt baseline and trial endpoint (8 weeks), data collection will include anthropometric measurements, dietary intake, biochemical indices, inflammatory and oxidative stress markers in blood samples, hormones, bioavailability of phenolic compounds, as well as lifestyle parameters i.e., health-related quality of life, physical activity levels, sleep quality. Ethical approval, informed consent, and data protection procedures will be strictly followed. Statistical analyses will be conducted using SPSS software (SPSS Inc, ΙΒΜ, Chicago, IL, USA).\n\nThe study is anticipated to explore whether consumption of high-phenolic olive oil favorably modulates markers related to obesity and metabolic abnormalities, while also improving nutritional status and quality-of-life parameters.",[82,29,653,654],"Metabolic Abnormalities","Consented to Participate in the Trial and Signed an ICF",[656,423,657,658,659,660,661],"extra virgin, high-phenolic olive oil","obesity","metabolic disorders","metabolism","oxidative stress","inflammation","2026-02-26",{"date":664,"type":34},"2026-03-03",{"date":666,"type":34},"2025-03-03",{"date":377,"type":23},{"name":669,"class":104},"University of Peloponnese",{"id":671,"slug":672,"hasResults":12,"nctId":673,"briefTitle":674,"officialTitle":675,"acronym":676,"eligibilityCriteria":677,"healthyVolunteers":12,"sex":18,"minAge":678,"maxAge":4,"enrollmentInfo":679,"targetDuration":4,"studyType":24,"phases":681,"briefSummary":682,"conditions":683,"keywords":690,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":698,"lastUpdatePostDateStruct":699,"startDateStruct":701,"completionDateStruct":702,"leadSponsor":704,"locationsCount":42},"100575341","community-physical-exercise-program-in-chronic-disease-100575341","NCT06771024","Community Physical Exercise Program in Chronic Disease","Effectiveness of Community Physical Exercise Program in Chronic Disease (CPEP - Chronic Disease), a Clinical Randomized Controlled Trial","CPEPCD","Inclusion Criteria:\n\n* Adults aged ≥50 years;\n* At least 2 of the following: Prior cardiovascular disease (\\>12 months); High cardiovascular risk (SCORE2 or SCORE2 O.P.); Post-stroke (ischemic or hemorrhagic) with treated etiology; Type 2 Diabetes (\\> 6 months, ADA); Osteoarthristis (clinical signs\u002Fsymptoms, NICE); Overweight\u002FObesity (BMI ≥ 27 kg\u002Fm2).\n* Autonomous walking.\n* Able to provide informed consent.\n* Stable medications for ≥ 3 months (related to diagnoses of interest).\n* Physical activity below WHO recommendations.\n* No contraindications to exercise (cardiovascular, cerebrovascular, respiratory, musculoskeletal) according to ACSS.\n\nExclusion Criteria:\n\n* Moderate to severe cognitive impairment - Montreal Cognitive Assessment (MoCA).\n* Type 2 Myocardial Infarction.\n* Class III or IV angina (Canadian Cardiovascular Society).\n* Class III or IV angina (New York Heart Association).\n* Uncontrolled CVD: symptomatic arrhythmias with hemodynamic compromise; severe symptomatic aortic valve stenosis; uncontrolled symptomatic heart failure; endocarditis, pericarditis, or active myocarditis; acute aortic syndrome; suspected or known dissecting aneurysm; acute systemic infections.\n* Pacemaker user.\n* Neurological disorders affecting gait.\n* Severe diabetes-related complications contraindicating exercise (poor metabolic control, diabetic foot, diabetic retinopathy, diabetic nephropathy, and diabetic autonomic neuropathy).\n* Recent use of insulin or sulphonylureas (\\\u003C 3 months).\n* Untreated stroke etiology: indication for revascularization; non-anticoagulated atrial fibrillation; intracranial atherosclerotic occlusive disease.\n* Musculoskeletal or ocular conditions preventing strength training (acute herniated disc, fractures, recent spinal surgery, glaucoma with elevated intraocular pressure).\n* Terminal illness.\n* Inability to understand basic oral or written Portuguese.\n* Participation in supervised dietary intervention.","50 Years",{"count":680,"type":23},150,[75],"This study focuses on promoting physical activity (PA) through the implementation of a Community Physical Exercise Program for Chronic Diseases (CPEP-CD), targeting individuals aged 50 years and older with at least two of the following conditions: cardiovascular and\u002For cerebrovascular disease or risk (CVD), overweight, diabetes mellitus (DM), and musculoskeletal diseases. The primary objective is to improve muscle and cardiorespiratory health and well-being, while also contributing to a more objective and evidence-based exercise prescription for these pathological conditions.\n\nPopulation ageing is a global challenge associated with an increased prevalence of chronic diseases that compromise quality of life (QoL). A sedentary lifestyle is linked to declines in muscle function and cardiorespiratory fitness and is considered a major risk factor for morbidity and mortality. Consequently, physical exercise is widely recommended as a key non-pharmacological intervention across multiple chronic diseases.\n\nAccording to World Health Organization (WHO) guidelines, regular PA is a protective factor in the prevention and management of non-communicable diseases, including cardiovascular and cerebrovascular diseases and DM. In addition, PA provides mental health benefits, supports healthy weight maintenance, and enhances overall well-being. In adults, regular PA is associated with reductions in all-cause mortality, cardiovascular mortality, and the incidence of hypertension.\n\nWithin this context, the aim of this project is to implement a community-based physical exercise program for individuals with chronic disease and multimorbidity, focusing on CVD and cerebrovascular disease or risk, DM, and OA. The program integrates existing exercise prescription guidelines while personalizing exercise progression according to both disease-specific and multimorbidity profiles. The primary outcomes include improvements in cardiorespiratory fitness, muscular strength, bone health, functional capacity, and QoL. Additionally, through individualized training monitoring, this study seeks to establish an exercise prescription tailored to the most prevalent combinations of chronic diseases, thereby providing more objective and practical guidance for family physicians, exercise professionals, and rehabilitation specialists, and supporting more personalized and targeted exercise-based strategies for chronic disease prevention and management.",[684,685,686,687,688,29,689],"Osteoarthritis Pain","Myocardial Infarction (MI)","Hypertension","Dyslipidemia","Diabetes Mellitus","Stroke",[691,692,693,694,695,696,688,697],"Physical Exercise Program","Healthy Ageing","Cardiovascular Risk","Osteoarthritis","Multimorbility","Chronic Diseases","Cerebrovascular risk","2026-02-04",{"date":700,"type":34},"2026-02-06",{"date":507,"type":23},{"date":703,"type":23},"2026-12",{"name":705,"class":706},"Associação para o Desenvolvimento do Centro Académico de Investigação e Formação Biomédica do Algarv","NETWORK",{"id":708,"slug":709,"hasResults":12,"nctId":710,"briefTitle":711,"officialTitle":712,"acronym":4,"eligibilityCriteria":713,"healthyVolunteers":12,"sex":18,"minAge":714,"maxAge":444,"enrollmentInfo":715,"targetDuration":4,"studyType":24,"phases":717,"briefSummary":718,"conditions":719,"keywords":720,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":722,"lastUpdatePostDateStruct":723,"startDateStruct":725,"completionDateStruct":727,"leadSponsor":729,"locationsCount":42},"100622852","exercise-chronotype-and-prediabetes-100622852","NCT07389005","Exercise, Chronotype, and Prediabetes","Timed Exercise in Prediabetes With Extreme Chronotype","Inclusion Criteria:\n\n1. Able to provide signed and dated written informed consent prior to any study specific procedures\n2. Adult men and women aged between more than 18 and ≤ 75 years\n3. Body mass index (BMI) of 25 - 35 kg\u002Fm2\n4. Stable weight (no weight loss or gain \\> 3 kg in the past 3 months)\n5. Pre-diabetes defined as an isolated impaired glucose tolerance or a combination of impaired glucose tolerance and impaired fasting glucose (values are based on the American Diabetes Association (ADA):\n\n   1. impaired glucose tolerance (plasma glucose 140 mg\u002FdL to 199 mg\u002FdL, 120 minutes after consumption of 75g of glucose)\n   2. impaired fasting glucose (fasting plasma glucose 100 mg\u002FdL to 125 mg\u002FdL)\n6. Morning (Morningness-Eveningness Questionnaire \\[MEQ\\] score ≥ 59) or evening (MEQ score ≤ 41) chronotype\n\nExclusion Criteria:\n\n1. Previously diagnosed with type 2 diabetes\n2. Moderate to severe anemia (hemoglobin \\\u003C 10 g\u002FL)\n3. Uncontrolled hypertension\n4. Abnormal electrocardiogram (ECG) at rest judged by the study physician\n5. Pregnancy or breastfeeding\n6. HIV, hepatitis B, or C infection\n7. Disorders of blood clotting or wound healing\n8. Positive history of venous thrombosis (contraindication for clamp)\n9. Hypersensitivity to local anesthetics (contraindication for fat\u002Fmuscle biopsies)\n10. Night shift work in the last 3 months\n11. Travel across \\> 1 time zone in the last 3 months\n12. Participation in another clinical trials that may possibly hamper the study results\n13. Engagement in structured exercise activities \\> 2 hours a week\n14. Any acute condition, exacerbation of chronic condition, or medical history that in the investigator's opinion would interfere with the study\n15. Any contraindication for MRI scanning\n16. Medication use known to hamper safety during the study procedures\n17. Non-German speaking","19 Years",{"count":716,"type":23},28,[75],"The goal of this clinical trial is to find out whether exercising at the right time of day, based on a person's natural body clock, leads to greater health benefits in people living with prediabetes. The main question it aims to answer is whether doing a single session of exercise in the morning or in the evening affects how the body handles sugar differently in adults with prediabetes who have an extreme natural body clock. This will be done by comparing three conditions (no-exercise, morning exercise, and evening exercise) within the same participant. Each condition will be tested on a different day, with at least 14 days between the test days. During the no-exercise test days, participants will come to the study centre and will only be allowed to do sedentary activities (e.g. office work, reading, or screen time). During the morning exercise test days, participants will perform an exercise session at 9:00 am that involves short periods of very hard effort followed by short rest periods. Whereas for the evening exercise test days, the same type of exercise will be performed at 5:00 pm.",[394,29],[394,87,88,454,721],"Chronotype","2026-01-28",{"date":724,"type":34},"2026-02-05",{"date":726,"type":23},"2026-02",{"date":728,"type":23},"2028-08",{"name":730,"class":104},"German Diabetes Center"]