[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"obesity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:obesity":25},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,797,0,25,[9,44,73,97,117,139,164,188,210,231,253,282,303,328,358,382,400,420,441,461,491,519,544,566,583],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100626618","a-natural-history-of-genetic-and-environmental-predictors-of-pubertal-timing-among-youth-with-obesity-100626618",false,"NCT07437976","A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study, including sharing medical records\n2. Male or female, aged 5 to 7 years at the screening visit\n3. Normal weight (defined as BMI \\> 5th percentile and \\\u003C85th percentile for age and sex) or Obese weight (defined as BMI \\> 95th percentile for age and sex)\n4. Ability of parent or guardian to understand and willingness to sign a written informed consent document. And ability of the participant (child) to provide verbal assent and\u002For to sign a written assent document.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Known diagnosis of syndromic\u002Fgenetic form of obesity\n2. Current use of medications or supplements that affect reproductive hormones (e.g., estrogen, progesterone, testosterone, puberty blockers, regular use of lavender oil or tea tree oil)\n3. Chronic medical conditions (e.g., type 1 or type 2 diabetes, cancer, renal failure, lupus, etc.), at the discretion of the Principal Investigator\n4. Clinically significant abnormal laboratory values, at the discretion of the Principal Investigator\n5. International adoptee (associated with earlier puberty)\n\nIndividuals who do not meet the criteria for participation in this study (screen failure) because of an acute, reversible or transient medical reason may be rescreened upon reversal, improvement or stabilization of their clinical status. Participants who develop an acute, reversible or transient medical condition during the study may return upon reversal, improvement or stabilization of their clinical status.","ALL","5 Years","12 Years",{"count":20,"type":21},400,"ESTIMATED","OBSERVATIONAL","Background:\n\nObesity affects 1 in 5 children in the United States. Childhood obesity often persists into adolescence and adulthood. It can also raise the risk of sleep apnea, fatty liver disease, and fluid buildup in the brain and lead to early-onset puberty. This natural history study will explore how factors such as genes, hormones, diet, and chemical exposures affect puberty in children with obesity.\n\nObjective:\n\nTo learn which factors predict the early start of puberty in children with obesity vs those of normal weight.\n\nEligibility:\n\nChildren aged 5 to 7 years with obesity or of normal weight.\n\nDesign:\n\nParticipants will have clinic visits every 6 months until they reach age 12.\n\nEach clinic visit will include these tests and procedures:\n\nA physical exam.\n\nCollection of blood, urine, and saliva samples. Some samples will be used for genetic tests.\n\nQuestions about medical history and medications and supplements.\n\nA questionnaire about their physical activity over the previous week.\n\nA silicone wrist band. Participants will wear a soft wristband for a week prior to each visit. It will tell researchers what chemicals the children were exposed to during that time.\n\nBreast ultrasound, for girls. A gel will be applied, and a wand will be pressed against the skin. The wand uses sound waves to see the tissue inside the breast.\n\nDXA whole body scan. Once a year, participants will have a DXA (dual energy X-ray absorptiometry) scan. This scan measures the amount of bone, muscle, and fat in the body.\n\nOptional food diary. Parents may record everything the participant eats for two 24-hour periods\n\n...",[25],"Obesity",[27,25,28,29,30],"ADRENARCHE","Reproductive Hormones","Puberty","Environmental predictors","NOT_YET_RECRUITING","2026-08-20",{"date":34,"type":35},"2026-08-21","ACTUAL",{"date":37,"type":21},"2026-08-26",{"date":39,"type":21},"2036-12-23",{"name":41,"class":42},"National Institute of Environmental Health Sciences (NIEHS)","NIH",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100623096","phase-3-a-study-of-eloralintide-ly3841136-in-participants-with-persistent-obesity-who-are-treated-with-a-weekly-incretin-100623096","NCT07392190","A Study of Eloralintide (LY3841136) in Participants With Persistent Obesity Who Are Treated With a Weekly Incretin","A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Persistent Obesity or Overweight Treated With a Weekly Incretin, With and Without Type 2 Diabetes","ENLIGHTEN-6","Inclusion Criteria:\n\n* Are on stable incretin therapy at screening\n* With persistent obesity or overweight defined as:\n\n  * ≥30 kg\u002Fm2 OR\n  * ≥27 kg\u002Fm2 with at least one existing obesity related complication at screening:\n\n    * hypertension\n    * dyslipidemia\n    * obstructive sleep apnea\n    * cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure), or\n    * type 2 diabetes\n* Have a stable body weight (\\\u003C5% body weight change) at screening\n\nExclusion Criteria:\n\n* Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed \\>1 year before screening)\n* Have a prior or planned endoscopic procedure and\u002For device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)\n* Have type 1 diabetes\n* Have taken any of the following antihyperglycemic medications within 90 days before screening:\n\n  * dipeptidyl peptidase-4 (DPP-4) inhibitors\n  * amylin analogs\n  * insulin\n* Have had within 90 days prior to screening:\n\n  * heart attack\n  * stroke\n  * coronary artery revascularization\n  * unstable angina, or\n  * hospitalization due to congestive heart failure\n* Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure","18 Years",{"count":54,"type":21},900,"INTERVENTIONAL",[57],"PHASE3","The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo in participants with persistent obesity or overweight, with or without type 2 diabetes, and on stable incretin background therapy.\n\nParticipation in the study will last about 80 weeks.",[60,25],"Overweight",[62],"Amylin receptor agonist","RECRUITING",{"date":34,"type":35},{"date":66,"type":35},"2026-02-10",{"date":68,"type":21},"2028-07",{"name":70,"class":71},"Eli Lilly and Company","INDUSTRY",187,{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":16,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":93,"leadSponsor":95,"locationsCount":43},"100622816","evaluation-of-the-clinical-spectrum-of-diabetes-and-obesity-in-youth-and-adults-100622816","NCT07388537","Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Age 8 years to 65 years\n2. Meet at least one of the following:\n\n   a. Overweight\u002FObesity:\n\n   i. For participants under 18 years of age: BMI \\>= 85th percentile for age and sex\n\nii. For participants \\>= 18 years of age: BMI \\>= 25 kg\u002Fm\\^2 (\\>=23 kg\u002Fm\\^2 for self-reported Asian race\u002Fethnicity)\n\nb. Suspected or evidence of hyperglycemia:\n\ni. Diagnosis of prediabetes or diabetes in medical history or by participant\u002Fguardian\u002FLegally Authorized Representative (LAR) report, OR\n\nii. Fasting blood glucose \\>= 100 mg\u002FdL in medical record, OR\n\niii. Postprandial blood sugar \\>= 140 mg\u002FdL in medical record, OR\n\niv. Hemoglobin A1c \\>= 5.7% in medical record\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. History of significant medical illnesses that the investigators feel may interfere with potential evaluations, i.e. individuals who are critically ill, unstable, or with severe organ failure that may affect\u002Flimit the endocrine evaluation and place unsustainable demands on Clinical Center or NIDDK resources.\n2. History of any medical, psychiatric, or social conditions which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the participant.\n3. Inability or unwillingness of participant, parent\u002Fguardian, or LAR to provide informed consent.","8 Years","65 Years",{"count":82,"type":21},1000,"Background:\n\nDiabetes and obesity are chronic diseases. They can affect blood flow and how the body processes nutrients, and complications over time can lead to early death. Diabetes can affect children as well as adults, but the disease seems to be more severe and to progress faster when it appears in younger people. Researchers want to understand more about how diabetes and obesity develop and change over time.\n\nObjective:\n\nTo collect data and samples regularly from people with obesity and diabetes.\n\nEligibility:\n\nPeople aged 8 to 65 years. They must be overweight or obese; or have high blood sugar; or have problems with how their body uses food for energy.\n\nDesign:\n\nParticipants will have additional procedures during routine care visits at the NIH clinic.\n\nData collected for the study will include the following:\n\nInformation from the participant s medical chart will be kept for research.\n\nQuestionnaires will ask about participant s eating habits, feelings, sleep, and substance use. They will take 30 to 60 minutes. Care providers will address any issues revealed in these surveys.\n\nBlood, saliva, urine, and stool samples will be collected. Samples may be used for genetic tests.\n\nData and samples will be kept for future research.\n\nParticipants may remain in the study up to 30 years.",[25,85,86],"Diabetes","Metabolic Disorders",[88,25,89,90],"Clinical Spectrum of Diabetes","Hyperglycemia","Metabolic Disease",{"date":34,"type":35},{"date":37,"type":21},{"date":94,"type":21},"2055-04-30",{"name":96,"class":42},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)",{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":55,"phases":107,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":110,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},"100617689","phase-3-a-study-of-eloralintide-ly3841136-in-participants-with-obesity-or-overweight-without-type-2-diabetes-100617689","NCT07321886","A Study of Eloralintide (LY3841136) in Participants With Obesity, or Overweight Without Type 2 Diabetes","A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Obesity or Overweight, Without Type 2 Diabetes","ENLIGHTEN-1","Inclusion Criteria:\n\n* Have Body Mass Index (BMI) at screening of the following:\n\n  * 30 kilogram per square meter (kg\u002Fm2) OR\n  * 27 kg\u002Fm2 with at least one of the following weight-related health conditions at screening:\n\n    * high blood pressure\n    * dyslipidemia\n    * obstructive sleep apnea, or\n    * heart disease\n* Have a stable body weight (\\\u003C5% body weight change) for 90 days prior to screening.\n* Have a history of at least one self-reported unsuccessful dietary effort to reduce body weight\n\nExclusion Criteria:\n\n* Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed \\>1 year before screening)\n* Have a prior or planned endoscopic procedure and\u002For device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)\n* Have type 1 diabetes or type 2 diabetes\n* Have had within 90 days prior to screening:\n\n  * heart attack\n  * stroke\n  * coronary artery revascularization\n  * unstable angina, or\n  * hospitalization due to congestive heart failure\n* Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure\n* Have taken medications or alternative remedies intended for weight loss within 90 days of screening",{"count":106,"type":21},1980,[57],"The purpose of this study is to evaluate the efficacy and safety of eloralintide in adults with obesity or overweight who do not have type 2 diabetes. The study has two phases: a main phase and an extension phase.\n\nParticipation in the main phase of the study will last about 75 weeks. Participants with prediabetes will continue in the extension phase for another 2 years.",[25,60],{"date":34,"type":35},{"date":112,"type":35},"2026-02-06",{"date":114,"type":21},"2030-07",{"name":70,"class":71},162,{"id":118,"slug":119,"hasResults":12,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":55,"phases":127,"briefSummary":128,"conditions":129,"keywords":130,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},"100614669","phase-3-a-study-of-eloralintide-ly3841136-in-participants-with-obesity-or-overweight-and-type-2-diabetes-100614669","NCT07282600","A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, and Type 2 Diabetes","A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Obesity or Overweight, and Type 2 Diabetes","ENLIGHTEN-2","Inclusion Criteria:\n\n* Have type 2 diabetes\n* Are on stable treatment for type 2 diabetes for at least 90 days prior to screening\n* Have a BMI ≥ 27 kg\u002Fm2\n* Have a stable body weight (\\\u003C5% body weight change) for 90 days prior to screening\n\nExclusion Criteria:\n\n* Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed \\>1 year before screening)\n* Have a prior or planned endoscopic procedure and\u002For device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)\n* Have type 1 diabetes\n* Have taken any of the following antihyperglycemic medications within 90 days before screening:\n\n  * amylin analogs\n  * glucagon-like peptide-1 (GLP-1) receptor agonists\n  * glucose-dependent insulinotropic polypeptide\u002Fglucagon-like peptide-1 (GIP\u002FGLP) receptor agonists, or\n  * insulin\n* Have had within 90 days prior to screening:\n\n  * heart attack\n  * stroke\n  * coronary artery revascularization\n  * unstable angina, or\n  * hospitalization due to congestive heart failure\n* Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure\n* Have taken medications or alternative remedies intended for weight loss within 90 days of screening",{"count":126,"type":21},1035,[57],"The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo for body weight reduction in participants with overweight or obesity and type 2 diabetes. Participation in the study will last about 75 weeks.",[60,25],[131],"Type 2 Diabetes",{"date":34,"type":35},{"date":134,"type":35},"2025-12-15",{"date":136,"type":21},"2028-02",{"name":70,"class":71},159,{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":55,"phases":149,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":157,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},"100609513","phase-2-a-study-of-macupatide-ly3532226-and-eloralintide-ly3841136-alone-or-in-combination-in-adults-with-obesity-or-overweight-and-with-type-2-diabetes-100609513","NCT07215559","A Study of Macupatide (LY3532226) and Eloralintide (LY3841136), Alone or in Combination, in Adults With Obesity or Overweight and With Type 2 Diabetes","A Phase 2, Parallel-Group, Double-Blind, Placebo-Controlled Study to Investigate Weight Reduction With Macupatide and Eloralintide, Alone or in Combination, in Adult Participants With Obesity or Overweight and With Type 2 Diabetes","Inclusion Criteria:\n\n* Have type 2 diabetes\n* Have an HbA1c ≥7.5% to ≤10.5% at screening\n* Have been treated with any of the following, alone or in combination, for at least 3 months prior to screening\n\n  * Diet and exercise\n  * Stable dose of metformin\n  * Sodium-glucose cotransporter-2 (SGLT2) inhibitor\n* Have had a stable body weight (\\\u003C5% body weight gain and\u002For loss) for the 3 months prior to screening\n* Have a BMI of 27 or greater at screening\n\nExclusion Criteria:\n\n* Have any form of diabetes other than type 2 diabetes\n* Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \\>1 year prior to screening\n* Have any of the following cardiovascular conditions within 3 months prior to screening:\n\n  * acute myocardial infarction\n  * cerebrovascular accident (stroke)\n  * unstable angina, or\n  * hospitalization due to congestive heart failure\n* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years, exceptions include\n\n  * basal or squamous cell skin cancer\n  * in situ carcinomas of the cervix, or\n  * in situ prostate cancer\n* Have been prescribed any of the following receptor agonists (RA) or their combination for any indication within the last 6 months:\n\n  * amylin RA\n  * dual amylin and calcitonin RA\n  * glucagon-like peptide-1 receptor (GLP-1) RA\n  * glucose-dependent insulinotropic peptide (GIP)\u002FGLP-1 RA\n  * GLP-1\u002Fglucagon (GCG) RAs, or\n  * GIP\u002FGLP-1\u002FGCG RAs\n* Have used excluded antihyperglycemic medications within 3 months prior to screening (including, but not limited to, sulfonylureas, dipeptidyl peptidase-4 inhibitors, alpha-glucosidase inhibitors, thiazolidinediones, and meglitinides\n* Have used insulin for diabetic control within the prior year (short term use in certain situations allowed","75 Years",{"count":148,"type":21},200,[150],"PHASE2","The purpose of this study is to investigate weight reduction with macupatide and eloralintide, alone or in combination, in adult participants with obesity or overweight and with type 2 diabetes. Participation in the study will last about 48 weeks.",[25,60,153],"Diabetes Mellitus, Type 2",[155,156],"GIP","Amylin",{"date":34,"type":35},{"date":159,"type":35},"2025-10-16",{"date":161,"type":21},"2027-05",{"name":70,"class":71},42,{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":172,"enrollmentInfo":173,"targetDuration":4,"studyType":55,"phases":175,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":187},"100539853","intensive-weight-loss-intervention-versus-bariatric-surgery-for-adults-with-severe-and-complex-obesity-the-lightbar-randomised-trial-100539853","NCT06309238","Intensive Weight Loss Intervention Versus Bariatric Surgery for Adults With Severe and Complex Obesity: the LightBAR Randomised Trial","Intensive Weight Loss Intervention Versus Bariatric Surgery for Adults With Severe and Complex Obesity: the LightBAR Randomised Trial. Lighthouse Consortium on Obesity Management (LightCOM) Trial no 4","LightBAR","Please note that participants need to be invited in order to take part in the trial.\n\nInclusion Criteria:\n\n* Aged 18 to 60 years (inclusive) at time of screening.\n* Eligible for and willing to undergo bariatric surgery, i.e., fulfilment of criteria for bariatric surgery from the respective national health authorities:\n\n  * DK: BMI ≥ 35 kg\u002Fm2 with one or more of the following: T2D, severe hypertension, sleep apnoea requiring treatment, symptomatic arthrosis in lower extremities, female infertility related to overweight, or BMI\\>40 kg\u002Fm2 with other strong medical reasons for weight loss (28). Prior to surgery, an 8% weight loss is required as well as smoking cessation.\n  * UK: BMI of 35 kg\u002Fm2 to 40 kg\u002Fm2 and other significant disease (e.g., type 2 diabetes or high blood pressure), or BMI ≥40 kg\u002Fm2. Has been or is willing to receive intensive management in a specialist tier 3 obesity service (29).\n* Fit for anaesthesia and surgery.\n* Informed consent.\n\nExclusion Criteria:\n\n* Prior bariatric or hiatal surgery, not including intragastric balloons or duodenal-jejunal bypass sleeve (Endobarrier™ or similar) if the device has been removed \\>1 year before screening.\n* Use of any WLM (including liraglutide and semaglutide for diabetes) within last 3 months.\n* Conditions that contraindicate or complicate total diet replacement (including type 1 diabetes or other diabetes requiring basal bolus insulin therapy or insulin pump therapy (for Denmark) and any diabetes requiring insulin therapy (for UK), phenylketonuria, or other conditions requiring strict adherence to special diets).\n* Conditions that contraindicate or complicate treatment with GLP-1 receptor analogues (including history of pancreatitis or known allergies).\n* Conditions that contraindicate or complicate bariatric surgery (GI motility disorders, large abdominal wall hernia, large hiatus hernia (\\>5cm), Crohn's disease, liver cirrhosis, or other conditions preventing laparoscopic bariatric surgery e.g. multiple previous abdominal surgery).\n* Conditions that contraindicate or complicate study adherence and bariatric surgery (mental disorder, unstable psychiatric disease, recent history of alcohol\u002Fmedication abuse, cancer treatment within 5 years).\n* Pregnant or planning pregnancy in the next two years or currently breast feeding.\n* Not achieving a 5% weight loss within 12 weeks prior to randomisation.\n* People taking part in other research involving multidisciplinary obesity treatment that would compromise their participation in this trial.\n* Another member of the household enrolled in the trial.\n* Diagnosis of or treatment for severe eating disorder within the last 6 months.","60 Years",{"count":174,"type":21},500,[176],"NA","With this trial, the aim is to assess the benefits and harms of a non-surgical intensive weight loss intervention that includes total dietary replacements, behavioural support and weight-loss medication compared with bariatric surgery for people with severe and complex obesity. The interpretation of the results will help inform future care pathways for people with obesity in whom bariatric surgery is currently the only available effective treatment option.",[25],{"date":34,"type":35},{"date":181,"type":35},"2024-05-08",{"date":183,"type":21},"2048-12",{"name":185,"class":186},"Carsten Dirksen","OTHER",14,{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":195,"sex":16,"minAge":52,"maxAge":80,"enrollmentInfo":196,"targetDuration":4,"studyType":55,"phases":198,"briefSummary":199,"conditions":200,"keywords":202,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":205,"startDateStruct":206,"completionDateStruct":207,"leadSponsor":209,"locationsCount":43},"100494101","trial-of-the-combination-of-alpha-lipoic-acid-and-mirabegron-in-women-and-in-men-with-obesity-100494101","NCT05713799","Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity","Phase II Trial of the Combination of Alpha-lipoic Acid and Mirabegron in Women and in Men With Obesity","* INCLUSION CRITERIA\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Adults 18 to 65 years of age\n2. BMI greater than or equal to 30 kg\u002Fm\\^2 and less than or equal to 45 kg\u002Fm\\^2\n\nEXCLUSION CRITERIA\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Hypersensitivity and associated allergic reactions to mirabegron or alpha-lipoic acid (or similar drug substances or components).\n2. Abnormal bladder function, diagnosis of bladder outlet obstruction, urgency, and urinary frequency or use of antimuscarinic medication to treat overactive bladder (OAB).\n3. Type 1 diabetes mellitus; type 2 diabetes mellitus; or any person taking exogenous insulin therapy or any medication that is a hypoglycemic agent. (type 1 or Type 2 Diabetes mellitus, fasting serum glucose \\>125 mg\u002FdL, and\u002For an HbA1c test \\>6.5%).\n4. Elevated resting blood pressure \\>140\u002F90 mmHg.\n5. Individuals with eGFR \\\u003C60 ml\u002Fmin\u002F1.72 m\\^2 and a urinary albumin\u002Fcreatinine ratio UACR\\>300 mg\u002Fg.\n6. Hypo- or hyper-thyroid disease (TSH \\>5.0, or \\\u003C0.4 MIU\u002FL) that is controlled for less than one year or someone currently taking thyroid hormone replacement.\n7. Anemia, defined by hemoglobin \\\u003C11.5 g\u002FdL (females) or \\\u003C13.5 g\u002FdL (males); sickle cell anemia or other blood disorders; and\u002For wound healing problems.\n8. Cardiovascular disease, cardiac arrhythmias, orthostasis, unstable vasomotor system, or renal impairment.\n9. A clinically significant abnormal ECG and\u002For QTc interval above normal\n10. Moderate hepatic impairment (Child-Pugh Class B) or above\n11. Elevated liver enzymes \\>75 U\u002FL (ALT or AST)\n12. Recent history in last 4 weeks of any local or systemic infectious disease with fever or requiring antibiotics\n13. Pregnancy, childbirth within the last year, or breastfeeding in the past 12 months.\n14. Individuals that have been on a very low-calorie diet (\\\u003C800 kcal\u002Fd), self-reported weight loss \\>5% in the preceding six months, or those taking weight loss medications.\n15. History of seizure disorder.\n16. Addiction to alcohol or substances of abuse within the last 5 years.\n17. Self-reported current alcohol consumption of more than 2 servings of alcohol per day.\n18. Self-reported current use of nicotine and\u002For tobacco products.\n19. Current use of any drugs known to:\n\n    1. Have major drug-drug interactions with mirabegron or alpha-lipoic acid\n    2. Be CYP2D6 substrates\n    3. Prolong QT interval\n    4. Alter glucose metabolism or cause insulin resistance (in last six months)\n    5. Treat diabetes mellitus\n    6. Treat hypertension\n    7. Be drugs of abuse\n20. Inability to provide informed consent.\n21. Unwilling or unable to eat metabolic meals, as determined by dietitian consult.\n22. Individuals with significant medical comorbidities or other factors that would render the individual s participation unsafe or affect the outcome of the study as assessed by the investigator.",true,{"count":197,"type":21},60,[150],"Background:\n\nObesity and related illnesses cause at least 2.8 million deaths each year worldwide. Few treatments exist for obesity that are safe and widely available. A study drug (mirabegron \\[MG\\]) combined with a supplement (alpha-lipoic acid \\[ALA\\]) may help.\n\nObjective:\n\nTo learn how MG and ALA can help the body process food.\n\nEligibility:\n\nPeople aged 18 to 65 years with a body mass index between 30 and 45 kg\u002Fm2.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam. They will have blood and urine tests and a test of their heart function. They will speak with a dietician.\n\nThe study has two phases. Each phase begins with a 2-day stay in the clinic; then the participant will take the study drugs at home for about 4 weeks, followed by another 2-day stay in the clinic. They will also have outpatient visits about 2 weeks after each clinic stay.\n\nDuring the clinic stays, participants will undergo many tests:\n\nThey will have a plastic tube (catheter) inserted into a vein in each arm. These will be used to draw blood and to infuse glucose (sugar) and insulin.\n\nThey will have imaging scans.\n\nThey will have a clear hard plastic shield placed over their head to measure oxygen and carbon dioxide as they breathe.\n\nParticipants will take the study drugs at home. Both MG and ALA are taken by mouth with water. During one phase, participants will take MG plus a placebo. A placebo looks like the study drug but doesn t contain medicine....",[201,25],"Insulin Resistance",[25,203,201,204],"Insulin Sensitivity","Placebo",{"date":34,"type":35},{"date":37,"type":21},{"date":208,"type":21},"2030-03-01",{"name":96,"class":42},{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":12,"sex":16,"minAge":217,"maxAge":52,"enrollmentInfo":218,"targetDuration":4,"studyType":55,"phases":220,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":224,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":43},"100471095","phase-2-the-gut-microbiome-in-type-1-diabetes-and-mechanism-of-metformin-action-100471095","NCT05414409","The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action","The Gut Microbiome in Lean and Overweight Youth With Type 1 Diabetes and Novel Mechanism of Action of Metformin","Inclusion Criteria:\n\n1. Overweight\u002Fobese youth 11-18 years of age with T1D at time of enrollment.\n2. Lean youth 11-18 years of age with T1D at time of enrollment.\n\nExclusion Criteria:\n\n1. Known monogenic forms of diabetes or Type 2 diabetes (confirmed clinically and by genetic\u002Fantibody testing).\n2. History of ongoing infection or antibiotic treatment within the past month;\n3. History of immune-compromise, recurrent infections, steroid intake (inhaled or oral forms) or other immunosuppressant use in the past 6 months.\n4. History of chronic gastrointestinal disease and active within the past 6 months, possible or confirmed celiac disease.\n5. Participation in any research intervention trials within the past 3 months.\n6. History of treatment or use of metformin, a type 2 diabetes medication.","11 Years",{"count":219,"type":21},114,[150],"Ovwerweight and obesity prevalence in persons with T1D has increased, which further complicates management and risk for complications. The proposed study is relevant to public health because it helps us understand the role of the gut microbiome in disease pathophysiology in T1D youth with overweight and obesity as well as potential mechanisms to modify disease.",[223,25],"Type 1 Diabetes",{"date":34,"type":35},{"date":226,"type":35},"2022-09-30",{"date":228,"type":21},"2027-03-01",{"name":230,"class":186},"Heba M. Ismail",{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":238,"enrollmentInfo":239,"targetDuration":4,"studyType":55,"phases":241,"briefSummary":242,"conditions":243,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":252},"100644100","phase-2-a-study-to-test-whether-bi-3034701-helps-people-to-lose-weight-who-live-with-obesity-or-overweight-100644100","NCT07662122","A Study to Test Whether BI 3034701 Helps People to Lose Weight Who Live With Obesity or Overweight","A Phase II, Randomised, Double-blind, Parallel-group, 42-week Dose-finding Trial for BI 3034701 Administered Subcutaneously Compared to Placebo in Participants With Obesity or Overweight","Inclusion criteria:\n\n1. Male or female, age ≥18 to \\\u003C75 years at the time of signing informed consent, and at least the legal age of consent in countries where it is \\>18 years\n2. Body mass index (BMI) ≥30 kg\u002Fm² at screening, OR BMI ≥27 kg\u002Fm² at screening with the presence of at least 1 weight-related complication.\n3. History of at least one self-reported unsuccessful dietary effort to lose body weight\n4. Signed and dated written informed consent in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. Persons must be capable of giving informed consent independently\n5. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use will be provided in the participant information sheet and in protocol.\n6. In the investigator's opinion, participants are well-motivated, capable, and willing to: Sign the informed consent form (ICF); Learn how to self-inject the investigational medicinal product (IMP)(s) in the abdomen as required for this protocol (persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the IMP(s)) OR Inject the IMP or accept injection from a designated person; Follow study procedures for the duration of the study, including, but not limited to: follow lifestyle advice (for example, dietary restrictions and physical activity plan), maintain diaries, complete required questionnaires, and handle the IMP(s) as described in the instructions for use (IFU)\n\nExclusion criteria:\n\n1. Body weight increase or decrease (self-reported) of greater than 5% in the 3 months prior to screening\n2. Treatment with anti-obesity medication and\u002For body weight change-inducing medication within 3 months before screening\n3. Prior surgery of the gastrointestinal (GI) tract that could interfere with body weight including minimally invasive\u002Fendoscopic bariatric devices and any bariatric or metabolic surgery involving resection, sleeve gastrectomy, or bypass procedures (e.g. Roux-en-Y, one-anastomosis gastric bypass, duodenal-jejunal bypass sleeve), regardless of whether the device or bypass was removed. The following are allowed: (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\n4. Have obesity induced by other endocrinologic disorders (for example, Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, melanocortin 4 receptor deficiency, leptin deficiency, or Prader Willi Syndrome)\n5. A Haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol\u002Fmol) as measured by the central laboratory at screening\n6. History of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) or treatment with glucose-lowering agent starting within 3 months before screening\n7. Use of glucagon-like-peptide-1 receptor (GLP-1R), glucose-dependent insulinotropic polypeptide receptor (GIPR), glucagon receptor (GCGR) or neuropeptide Y receptor 2 (NPY2R) agonists (or the combinations thereof) within 3 months before screening\n8. Answered \"yes\" to any of the suicide-related behaviours (actual attempt, interrupted attempt, aborted attempt, preparatory act or behaviour) or to the non-suicidal self-injurious behaviour question on the \"Suicidal Behaviour\" section of the Columbia-Suicide Severity Rating Scale (C-SSRS) related to the past 2 years before screening visit up to and including the randomisation visit Further exclusion criteria apply.","74 Years",{"count":240,"type":21},300,[150],"This study is open to adults between 18 and 74 years of age and who have a body mass index (BMI) of 30 kg\u002Fm2 or more, or a BMI of 27 kg\u002Fm2 or more and at least 1 health problem related to their weight. People who have previously not managed to lose weight by changing their diet can participate. People with type 2 diabetes cannot take part in this study.\n\nThe purpose of this study is to find out whether a medicine called BI 3034701 helps people living with obesity or overweight to lose weight. This study has 7 groups of participants. Groups 1 to 6 get different doses of BI 3034701; Group 7 gets placebo. Placebo looks like BI 3034701 but does not contain any medicine. Every participant has more than an 80% chance of getting BI 3034701. Participants receive 2 injections of BI 3034701 or placebo under their skin for 42 weeks. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly.\n\nParticipants are in the study for about 10 months. During this time, they visit the study site 15 times. The study doctors regularly measure the participants' body weight and take necessary laboratory tests. Participants also answer questions about their well-being and note their food intake and physical activity in diaries. The results will be compared between groups of participants to see whether the treatment works. The study doctors also regularly check participants' health and take note of any unwanted effects.",[25,60],"2026-08-19",{"date":32,"type":35},{"date":247,"type":35},"2026-06-30",{"date":249,"type":21},"2027-08-18",{"name":251,"class":71},"Boehringer Ingelheim",55,{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":261,"enrollmentInfo":262,"targetDuration":264,"studyType":22,"phases":4,"briefSummary":265,"conditions":266,"keywords":267,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":281},"100652768","longitudinal-study-of-the-psychological-impact-of-bariatric-surgery-100652768","NCT07780058","Longitudinal Study of the Psychological Impact of Bariatric Surgery","Psychological Impact of Bariatric Surgery in Patients With Morbid Obesity: a Longitudinal Study Protocol","BARI-SCL","Inclusion Criteria:\n\n* Men and women aged 18 to 70 years who are candidates for gastric bypass, sleeve gastrectomy, or single-anastomosis duodeno-ileal bypass (SADI-S), with a body mass index of at least 40 kg\u002Fm² or at least 35 kg\u002Fm² with comorbidities, and who are able to provide informed consent.\n\nExclusion Criteria:\n\n* Patients with previous bariatric surgery and pregnant women during follow-up will be excluded.","70 Years",{"count":263,"type":21},70,"3 Years","This prospective observational study evaluates the effect of bariatric surgery on mental health and hair cortisol in patients with morbid obesity over a 3-year follow-up. Assessments will be performed before surgery and at 1 month, 1 year, 2 years, and 3 years to analyze psychological changes, weight changes, and the need for psychological support.",[25],[268,269,270,271,272],"psychological well-being","bariatric surgery","hair cortisol","morbid obesity","follow-up","2026-08-18",{"date":34,"type":35},{"date":276,"type":35},"2025-09-02",{"date":278,"type":21},"2028-10-28",{"name":280,"class":186},"University of Alicante",2,{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":195,"sex":16,"minAge":52,"maxAge":80,"enrollmentInfo":289,"targetDuration":4,"studyType":55,"phases":291,"briefSummary":293,"conditions":294,"keywords":295,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":297,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":281},"100649815","phase-1-a-study-of-eloralintide-ly3841136-in-participants-with-obesity-or-overweight-100649815","NCT07738614","A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight","A Phase 1, Investigator- and Participant-Blinded, Placebo-Controlled, Randomized, Multiple-Dose Study to Evaluate the Gastric Emptying Delay, Pharmacokinetics, Safety, and Tolerability of Eloralintide in Participants With Obesity or Overweight","Inclusion Criteria:\n\n* Have overweight or obesity, but are otherwise overtly healthy.\n* Have a body mass index (BMI) within the range of 27.0 to 45.0 kilograms (kg)\u002Fsquare meter (m²), inclusive.\n* Have had a stable body weight, with less than 5 percent (%) change during the 3-month period prior to screening.\n\nExclusion Criteria:\n\n* Have been diagnosed with Type 1 or Type 2 diabetes mellitus, or have either of the following at screening\n\n  * A fasting plasma glucose concentration greater than or equal to 126 milligrams (mg)\u002Fdeciliter (dL) or 7.0 millimoles (mmol)\u002Fliter (L), or\n  * Hemoglobin A1C (HbA1c) greater than or equal to 6.5% or 48 mmol\u002Fmole (mol).\n* Have a history or presence of psychiatric disorders, including a history of major depressive disorder or severe psychiatric disorders such as schizophrenia, and bipolar disorder, within the last 2 years.\n* Have received a glucagon-like peptide-1 (GLP-1) receptor agonist, glucose-dependent insulinotropic polypeptide (GIP)\u002FGLP-1 receptor agonist, or GIP\u002FGLP-1\u002Fglucagon receptor agonist within 60 days or 5 half-lives, whichever is longer, prior to screening.\n* Are in the judgment of the investigator, actively suicidal or deemed to be at significant risk for suicide.",{"count":290,"type":21},56,[292],"PHASE1","The main purpose of this study is to find out how significantly Eloralintide slows stomach emptying in participants who are overweight or obese. For each participant, the study will last approximately 21 weeks and will include 2 overnight stays in the clinical research unit (CRU) lasting between 4 and 8 days. There will be 13 other visits.",[25,60],[296],"Healthy",{"date":32,"type":35},{"date":299,"type":35},"2026-07-31",{"date":301,"type":21},"2026-12",{"name":70,"class":71},{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":195,"sex":310,"minAge":311,"maxAge":146,"enrollmentInfo":312,"targetDuration":4,"studyType":55,"phases":314,"briefSummary":315,"conditions":316,"keywords":317,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":321,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":43},"100307894","tailoring-mobile-health-technology-to-reduce-obesity-and-improve-cardiovascular-health-in-resource-limited-neighborhood-environments-100307894","NCT03288207","Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments","Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments: A Multi-Level, Community-Based Physical Activity Intervention","* INCLUSION CRITERIA:\n\nIndividuals eligible for this protocol are overweight or obese (BMI \\>= 25 kg\u002Fm\\^2) African American women aged 21-75 years who live in Washington, DC Wards 5,7, or 8 and neighboring areas of Prince George s County, MD. Eligible participants should also have access to a smartphone compatible with the mobile app for the protocol that they can use for the study. Eligible participants must be able to provide informed consent independently and also speak and read English at the 8th grade level.\n\nEXCLUSION CRITERIA:\n\n* Medical condition, including heart failure, recent unintentional weight loss or physical limitation, that might prohibit safe participation in physical activity for any reason\n* Heart disease as indicated by history of myocardial infarction in past 1 year, documented obstructive coronary artery disease on coronary angiography, coronary artery stent placement, within the last year significant structural heart disease (e.g. hypertrophic or dilated cardiomyopathy with EF \\\u003C35%, severe valvular heart disease) with evidence of decompensation.\n* Pregnant women due to large hormonal changes during pregnancy that affect study variables and potential pregnancy-related restrictions on exercise. All participants of childbearing potential will need to self-report a negative pregnancy at the screening visit, baseline visit, and at the three-month and six-month visits, unless the participant self-reports being postmenopausal, having had a tubal ligation, or having undergone a complete hysterectomy.\n\nPilot Study INCLUSION CRITERIA:\n\n* Must be an African-American female\n* Must be within the age of 21-75 years old\n* Must be overweight or obese (Body Mass Index (BMI) \\>= 25 kg\u002Fm\\^2)\n* Must live in Washington DC Wards (5, 7, or 8) or live in Prince George s County, Maryland\n* Must have a smartphone that is compatible with the study software (mobile app)\n* Must be willing to use the software on personal smartphone for the study\n* Must be able to provide consent\n* Must be willing to wear the wrist-worn physical activity device for the study\n* Must not be pregnant\n\nOptional MRI Tests\n\nSubjects will be screened for implanted metal objects or devices that may be incompatible with MRI (i.e. cerebral aneurysm clip, cochlear implant, pacemaker, etc.) These subjects will be eligible to proceed with study enrollment, but will not undergo the optional MRI study.","FEMALE","21 Years",{"count":313,"type":21},325,[176],"Background:\n\nHeart disease is a leading cause of death. People can reduce their heart disease risk by exercising more. Mobile health technology may make people more successful at increasing their exercise. This includes things like physical activity monitors and smartphone apps.\n\nObjective:\n\nTo find out if mobile health technology can increase physical activity.\n\nEligibility:\n\nAfrican American women ages 21-75 who:\n\n* Are overweight or obese\n* Live in certain areas near Washington, DC\n* Have a smartphone that can use the study app\n\nDesign:\n\nAt visit 1, participants will\n\n* Answer survey questions. These may be about medical history, physical activity, and weight. They may also cover body image, health perception, and spirituality.\n* Have body size measured and get blood tests\n* Get a device to wear on the wrist. It will record physical activity and hours of sleep.\n* Learn how to download and use the study mobile app\n\nFor 2 weeks, researchers will collect data about participants physical activity.\n\nThen participants will have a study visit with additional blood tests.\n\nAll participants will get messages from the app that encourage exercise.\n\nSome participants will get data from the app about exercise near their home or work.\n\nSome participants may get face-to-face coaching.\n\nParticipants may get wireless devices. These measure body weight, blood pressure, and blood glucose. Participants can measure these at home and upload the data to the app for the study.\n\nParticipants will have visits after 3 and 6 months. They will repeat the visit 1 tests.\n\n...",[25],[318,25,319,320],"Community-Based Participatory Research","Cardiovascular Disease Risk","Social Determinants of Health",{"date":244,"type":35},{"date":323,"type":35},"2018-06-21",{"date":325,"type":21},"2027-08-04",{"name":327,"class":42},"National Heart, Lung, and Blood Institute (NHLBI)",{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":334,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":55,"phases":338,"briefSummary":339,"conditions":340,"keywords":341,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":357},"100652683","phase-3-a-study-to-investigate-the-efficacy-and-safety-of-elecoglipron-in-asian-participants-with-obesity-or-overweight-with-or-without-type-2-diabetes-mellitus-100652683","NCT07775404","A Study to Investigate the Efficacy and Safety of Elecoglipron in Asian Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus","A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Evaluate the Efficacy and Safety of Elecoglipron in Asian Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus (EMBOLD-Asia)","Elecoglipron","Inclusion Criteria:\n\n* Adult participant aged 18 years or older at the time of informed consent.\n* Body mass index (BMI) at screening of:\n* 28 kg\u002Fm\\^2 or higher, or\n* 24 kg\u002Fm\\^2 to less than 28 kg\u002Fm\\^2 with at least 1 weight-related comorbidity.\n* Stable body weight (self-reported or documented) for 90 days prior to the screening visit (± 5% body weight change)\n* History of at least 1 self-reported unsuccessful dietary effort to lose body weight.\n* Participants with type 2 diabetes mellitus, if enrolled, and have HbA1c from 6.5% to less than 10.0% at screening.\n\nExclusion Criteria:\n\n* Any of the following medical history, laboratory values, or complications related to diabetes:\n* T1DM\n* HbA1c ≥ 10% (86 mmol\u002Fmol) at the screening visit\n* Currently receiving, or anticipated to receive, therapeutic intervention for diabetic retinopathy and\u002For macular edema.\n* Have had more than one episode of severe hypoglycemia within 180 days prior to the screening visit, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.\n* History of acute (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy) or chronic pancreatitis.\n* History\u002Ffamily history (first degree biologic relatives) of medullary thyroid cancer or multiple endocrine neoplasia type 2.",{"count":337,"type":21},351,[57],"The purpose of this study is to evaluate the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adult participants living with obesity or overweight with or without T2DM.",[25,60],[342,343,344,345,346,347,348],"elecoglipron","AZD5004","ECC5004","GLP-1 receptor agonist","Weight loss","Weight management","Type 2 diabetes mellitus","2026-08-17",{"date":32,"type":35},{"date":352,"type":21},"2026-08-28",{"date":354,"type":21},"2028-04-20",{"name":356,"class":71},"AstraZeneca",49,{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":195,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":55,"phases":366,"briefSummary":367,"conditions":368,"keywords":372,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":4},"100652155","negative-pressure-wound-therapy-devices-in-total-knee-arthroplasty-100652155","NCT07770633","Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty","Randomized Controlled Clinical Trial for Closed Incision Negative Pressure Wound Therapy (NPWT) Devices in Total Knee Arthroplasty (TKA)","Inclusion Criteria:\n\n* Age 18 years or older\n* Undergoing primary total knee arthroplasty\n* Able to understand the study, provide informed consent, and participate in study procedures\n\nMeet at least one of the following co-morbidities:\n\n* BMI ≥35\n* Diabetes\n* Prior surgical incision(s) in the operative area\n* Chronic kidney disease\n\nExclusion Criteria:\n\n* Prisoners\n* Pregnant women\n* Patients who indicate they may not comply with post-operative instructions\n* Patients with active bleeding",{"count":240,"type":21},[176],"This study is a single-center, prospective, randomized, open-label clinical trial evaluating three commercially available closed-incision negative pressure wound therapy (ciNPWT) devices: NPseal, PICO, and Prevena, in adult patients undergoing primary total knee arthroplasty (TKA) who meet predefined high-risk criteria for wound complications.\n\nA total of approximately 300 participants will be enrolled and randomized in a 1:1:1 fashion to receive one of the three study dressings applied over the closed surgical incision at the end of the procedure. All participants will otherwise receive standard perioperative and postoperative care. The primary follow-up period will extend through 90 days after surgery.\n\nThe primary objective is to compare the incidence of 90-day surgical site complications, including superficial infection, wound dehiscence, seroma, and hematoma, across the three dressing groups. Secondary objectives include evaluation of device usability, patient experience, and device-related issues (such as loss of seal, alarms, tubing or pump problems, fluid saturation, and premature dressing changes), as well as assessment of the interaction between skin closure method and device performance.\n\nResearch-specific activities are limited to eligibility confirmation, informed consent, randomization, administration of a brief postoperative patient survey at approximately postoperative day 7 and\u002For dressing removal, provider assessment of the dressing at removal, and collection of clinical outcomes from the medical record. No additional blood draws, imaging, or invasive procedures are required for participation.\n\nThis study is designed to address a gap in the literature by providing head-to-head comparative data on commonly used ciNPWT systems in a high-risk primary TKA population, with the goal of informing postoperative wound management strategies in clinical practice.",[369,85,25,370,371],"Wound Surgical","Chronic Kidney Diseases","Smoking",[373,374],"Total Knee Arthroplasty","Total Knee Replacement",{"date":273,"type":35},{"date":377,"type":21},"2026-09-01",{"date":379,"type":21},"2030-12",{"name":381,"class":186},"The Cleveland Clinic",{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":195,"sex":16,"minAge":52,"maxAge":389,"enrollmentInfo":390,"targetDuration":4,"studyType":55,"phases":392,"briefSummary":393,"conditions":394,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":395,"startDateStruct":396,"completionDateStruct":397,"leadSponsor":399,"locationsCount":43},"100652003","phase-1-a-study-to-compare-how-2-different-formulations-of-survodutide-are-taken-up-in-the-body-when-given-by-injection-in-healthy-men-and-women-with-and-without-overweight-or-obesity-100652003","NCT07768813","A Study to Compare How 2 Different Formulations of Survodutide Are Taken up in the Body When Given by Injection in Healthy Men and Women With and Without Overweight or Obesity","Bioequivalence of Survodutide (BI 456906) When Administered Via Pre-filled Syringe (Formulation A) and Vial (Formulation B2) in Male and Female Trial Participants Who Are Healthy or Otherwise Healthy But Overweight\u002FObese (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Trial)","Inclusion criteria:\n\n1. Male or female trial participant who is healthy or otherwise healthy with overweight\u002Fobesity according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests\n2. Age of 18 to 55 years (inclusive)\n3. Body mass index (BMI) of 22.0 to 39.9 kg\u002Fm\\^2 (inclusive)\n4. Signed and dated written informed consent in accordance with international council for harmonisation - good clinical practice (ICH-GCP) and local legislation prior to admission to the trial\n5. Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator\n2. Repeated measurement of systolic BP outside the range of 90 to 140 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 45 to 90 bpm\n3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance\n4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator\n5. Further exclusion criteria apply.","55 Years",{"count":391,"type":21},44,[292],"The main objective of this trial is to establish the bioequivalence of survodutide in a pre-filled syringe (reference product \\[formulation A\\]) and in a vial (test product \\[formulation B2\\]) in male and female trial participants who are healthy or otherwise healthy with overweight\u002Fobesity, following subcutaneous administration.",[296,25],{"date":273,"type":35},{"date":377,"type":21},{"date":398,"type":21},"2026-12-22",{"name":251,"class":71},{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":195,"sex":16,"minAge":52,"maxAge":80,"enrollmentInfo":407,"targetDuration":4,"studyType":55,"phases":409,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":413,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":43},"100646253","phase-1-a-study-to-see-how-safe-a-new-medicine-nnc6022-0004-is-in-healthy-people-and-people-living-with-obesity-100646253","NCT07693868","A Study to See How Safe a New Medicine (NNC6022-0004) is in Healthy People and People Living With Obesity","An NNC6022-0004 Single and Multiple Ascending Dose Study Investigating Safety, Tolerability, Pharmacokinetics, Food Effect and Target Engagement in Healthy Adults Including a Single Cohort in Adults Living With Obesity","Inclusion Criteria:\n\n* Male, or female of non-childbearing potential.\n* For Parts A, B, C and D: Age 18-55 years (both inclusive) at the time of signing the informed consent.\n\nFor optional Part E only: Age 18-65 years (both inclusive) at the time of signing the informed consent.\n\n-For Parts A, B, C and D: Body mass index (BMI) between 18.5 to 29.9 kilogram per meter square (kg\u002Fm\\^2) (both inclusive) at screening.\n\nFor optional Part E only: BMI between greater than or equal to (≥) 30.0 to less than or equal to (≤) 45.0 kg\u002Fm\\^2 at screening, or if BMI is between 27.0 and \\\u003C30.0 kg\u002Fm\\^2, waist to height ratio should be greater than (\\>)0.5.\n\n* Body weight: ≥50.0 kilogram (kg) at screening.\n* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.\n* For optional Part E only: hsCRP ≥2.00 and ≤8.00 milligrams per liter (mg\u002FL) during screening period in 2 separate samples taken ≥4 days apart.\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to study intervention(s) or similar products.\n* Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.\n* Any of the below laboratory safety parameters at screening outside normal range, see designated reference range documents for specific values.\n* Alanine Aminotransferase (ALT) \\> Upper limit of normal (ULN).\n* Alkaline Phosphatase (ALP) \\> ULN.\n* Aspartate aminotransferase (AST) \\> ULN.\n* Total Bilirubin (TBL) \\> ULN.\n* Creatinine \\> ULN.\n* International normalized ratio (INR) \\> ULN.\n* Fibrinogen outside normal range of 1.6 - 4.2 grams per liter (g\u002FL).\n* hsCRP \\> 5.00 mg\u002FL (males) and \\> 8.00 mg\u002FL (females)\\*.\n\n  * applicable for Parts A, B, C and D and for optional Part E: hsCRP \\>8.00 mg\u002FL.\n* Use of prescription medicinal products or vaccines within 14 days before screening and\u002For non prescription medicinal products within 7 days before dosing. Exceptions are: Topical medications not reaching systemic circulation; less than once per week of over-the-counter paracetamol, ibuprofen and\u002For acetylsalicylic acid at their labelled doses for mild pain; vitamins at their labelled doses.",{"count":408,"type":21},128,[292],"This study is being done to look at the efficacy single and multiple ascending dose study investigating safety, tolerability, pharmacokinetics, food effect and target engagement in healthy adults including a single cohort in adults living with obesity. Participants will either get NNC6022-0004, (the treatment being tested) or Placebo (a treatment that has no active medicine in it) and which treatment participants get is decided by chance.",[25,412],"Elevated High-sensitivity C-reactive Protein (hsCRP)",{"date":244,"type":35},{"date":415,"type":35},"2026-07-06",{"date":417,"type":21},"2027-08-01",{"name":419,"class":71},"Novo Nordisk A\u002FS",{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":426,"eligibilityCriteria":427,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":428,"targetDuration":4,"studyType":55,"phases":430,"briefSummary":431,"conditions":432,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":434,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":440},"100636539","phase-3-a-research-study-to-look-at-how-well-nnc0487-0111-works-compared-to-placebo-in-people-with-heart-failure-and-obesity-100636539","NCT07567001","A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity","Efficacy and Safety of NNC0487-0111 Compared to Placebo on Morbidity and Mortality in People With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity","HF-POLARIS","Inclusion Criteria:\n\n* Body Mass Index (BMI) greater than or equal to (\\>=) 30 kilograms per square metre (kg\u002Fm\\^2) at screening.\n* Diagnosis of HF with New York Heart Association (NYHA) class II-IV and in stable condition at screening, at the discretion of the investigator.\n\nFor participants with Type 2 Diabetes (T2D) at screening:\n\n\\- Diagnosed with T2D \\>= 30 days before screening.\n\nExclusion Criteria:\n\n* MI, stroke, unstable angina pectoris or worsening HF leading to either hospitalization or intravenous loop diuretics within 30 days prior to the day of screening and until randomization.\n* HF due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, Chagas cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, or uncorrected primary valve disease of moderate or severe degree.\n* Severe pulmonary disease including primary pulmonary hypertension, chronic pulmonary embolism, or severe chronic obstructive pulmonary disease (COPD) defined as:\n* requiring home oxygen; or - ongoing oral corticosteroid therapy; or - hospital for COPD Exacerbation within 12 months prior to screening.\n* Any other condition judged by the investigator to be the cause of HF symptoms (e.g., anaemia, hypothyroidism).\n\nGlycaemia-related:\n\n* History of type 1 diabetes.\n* Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or who, at the time of screening, are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.\n* Glycated haemoglobin (HbA1c) greater than (\\>) 10 percent (%) (86 \\[millimoles per mole\\] mmol\u002Fmol) as measured by local or central laboratory at screening.",{"count":429,"type":21},5610,[57],"This study is being done to look at the safety and effect of NNC0487-0111 in people with Heart Failure with preserved Ejection Fraction (HFpEF) or Heart Failure with mildly reduced Ejection Fraction (HFmrEF) and excess body weight when compared to placebo. The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have HFpEF or HFmrEF and excess body weight. Participants will get NNC0487-0111 or placebo by injection once a week. Which treatment participants get is decided by chance. NNC0487-0111 is a new medicine that doctors cannot prescribe yet, but it has been tested in people before.",[25,433],"Heart Failure",{"date":273,"type":35},{"date":436,"type":35},"2026-05-11",{"date":438,"type":21},"2029-08-15",{"name":419,"class":71},838,{"id":442,"slug":443,"hasResults":12,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":4,"eligibilityCriteria":447,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":80,"enrollmentInfo":448,"targetDuration":4,"studyType":55,"phases":450,"briefSummary":451,"conditions":452,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":453,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":460},"100569922","phase-1-a-first-in-human-study-of-aro-inhbe-in-adults-with-obesity-with-and-without-type-2-diabetes-mellitus-100569922","NCT06700538","A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus","A Phase 1\u002F2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARO-INHBE in Adult Volunteers With Obesity With and Without Diabetes Mellitus","Inclusion Criteria:\n\n* Obesity, defined as Body Mass Index (BMI) between 30 to 50 kilograms (kg)\u002Fsquare meter (m\\^2) at Screening\n* At least one self-reported, unsuccessful attempt at weight loss with lifestyle modification\n* Type 2 diabetes mellitus for at least 6 months prior to Screening, with glycated hemoglobin (HgbA1c) between 6.0% (42 millimole \\[mmol\\]\u002Fmole \\[mol\\]) and 9.5% (80 mmol\u002Fmol) at Screening, on a stable diabetes medication regimen for at least 3 months (select Part 2 and Part 3 cohorts only)\n* Willing, able and motivated to comply with all study assessments and adhere to the protocol schedule, including adherence to a stable diet and exercise routine for the duration of the study\n* No abnormal finding of clinical relevance at Screening that, in the opinion of investigator, could adversely impact participant safety or adversely impact study results\n* Participants of childbearing potential must agree to use highly effective contraception during the study and for at least 90 days following the end of the study or last dose of study medication, whichever is later. Participants must not donate sperm or eggs during the study and for at least 90 days following the end of the study or last dose of study medication, whichever is later.\n\nExclusion Criteria:\n\n* Self-reported (or documented) weight gain or loss \\>5% within 3 months prior to Screening\n* Use of glucagon-like protein 1 receptor (GLP1R) agonists (liraglutide, semaglutide, etc.) for any indication within 6 months prior to Screening\n* Use of non-GLP1R medications for weight loss within 3 months prior to Screening, including but not limited to naltrexone\u002Fbupropion, orlistat, phentermine\u002Ftopiramate, and other prescription or over-the-counter medication or supplements taken for weight loss\n* Obesity attributable, in the investigator's opinion, to medication use, monogenic, or endocrinologic disorders (other than polycystic ovary syndrome)\n* History or prior surgical or device-based therapy for obesity\n* Use of medications strongly associated with weight gain within 3 months prior to Screening\n* Type 1 diabetes mellitus\n* History of hyperthyroidism or thyroid-stimulating hormone (TSH) levels \\\u003C0.4 or \\>6.0 milli-international units (mIU)\u002Fliter (L) at Screening\n* Evidence of clinically significant end-organ disease\n\nNote: Other Inclusion\u002FExclusion criteria may apply per protocol",{"count":449,"type":21},180,[292,150],"This is a Phase 1\u002F2a double-blind dose-escalating study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of ARO-INHBE in adult participants with obesity (in Part 1), the safety, tolerability, PK, and PD of multiple doses of ARO-INHBE either as monotherapy, or in combination with tirzepatide, in adult participants with obesity with and without type 2 diabetes mellitus (in Part 2 and Part 3).",[25],{"date":273,"type":35},{"date":455,"type":35},"2024-12-04",{"date":457,"type":21},"2028-01-17",{"name":459,"class":71},"Arrowhead Pharmaceuticals",7,{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":467,"eligibilityCriteria":468,"healthyVolunteers":12,"sex":16,"minAge":469,"maxAge":470,"enrollmentInfo":471,"targetDuration":4,"studyType":55,"phases":473,"briefSummary":474,"conditions":475,"keywords":477,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":483,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":490},"100445598","phase-2-caloric-restriction-and-activity-to-reduce-chemoresistance-in-b-all-100445598","NCT05082519","Caloric Restriction and Activity to Reduce Chemoresistance in B-ALL","A Phase 2 Randomized Trial of Caloric Restriction and Activity to Reduce Chemoresistance in B-cell Acute Lymphoblastic Leukemia","IDEAL2","Inclusion Criteria:\n\n* Patients must be ≥ 7.0 and \\\u003C26.0 years of age.\n* Patients must have a diagnosis of de novo B-ALL\n* Patients must have a M3 marrow (\\>25% blasts by morphology) or at least 1,000\u002FµL circulating leukemia cells in PB confirmed by Flow Cytometry (or other convincing evidence of a B-ALL diagnosis not meeting above criteria following central review by the Study Hematopathologist and Study Chair or Vice-Chair).\n* The treatment regimen must be the first treatment attempt for B-ALL-\n* Must be a multi-agent induction regimen inclusive of vincristine, glucocorticoid, pegaspargase\u002Fcalaspargase, and daunorubicin or doxorubicin and with a planned duration \\\u003C35 days.\n* Organ function must meet that required for initiation of chemotherapy\n* Patients at diagnosis must meet Karnofsky \\> 50% for patients \\> 16 years of age and Lansky \\> 50% for patients ≤ 16 years of age (or be expected to recover prior to Day 8) .\n* If the patient is a female of childbearing potential, a negative urine or serum pregnancy test is required within two weeks prior to enrollment.\n\nExclusion Criteria:\n\n* Patient will be excluded if they are underweight at time of enrollment (BMI% \\\u003C5th percentile for age for patients age 10-19 years, BMI \\\u003C18.5 in patients 20-29 years).\n* Patients with Down syndrome or a DNA fragility syndrome (such as Fanconi anemia, Bloom syndrome) will be excluded.\n* Patient receiving a SJCRH-style \"Total Therapy\" regimen will be excluded.\n* Patients receiving anti-CD20 monoclonal antibody therapy during induction therapy.\n* Patients will be excluded if they received treatment for a previous malignancy.\n* Patient will be excluded if they are pregnant.\n* Patient will be excluded if they have a pre-diagnosis requirement for enteral or parenteral supplementation .\n* Patient will be excluded due to inability to perform the intervention (e.g., specific nutritional needs, severe developmental delay, paraplegia)\n* Patients will be excluded if they have significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with the protocol treatment or procedures, interfere with consent, study participation, follow up, or interpretation of study results","7 Years","25 Years",{"count":472,"type":21},240,[150],"This study is for older children, adolescents, and young adults with B-cell Acute Lymphoblastic Leukemia (B-ALL). Higher amounts of body fat is associated with resistance to chemotherapy in patients with B-ALL. Chemotherapy during the first month causes large gains in body fat in most people, even those who start chemotherapy at a healthy weight.\n\nThis study is being done to find out if caloric restriction achieved by a personalized nutritional menu and exercise plan during routine chemotherapy can make the patient's ALL more sensitive to chemotherapy and also reduce the amount of body fat gained during treatment. The goals of this study are to help make chemotherapy more effective in treating the patient's leukemia as demonstrated by fewer patients with leukemia minimal residual disease (MRD) while also trying to reduce the amount of body fat that chemotherapy causes the patient to gain in the first month.",[476,25],"B-cell Acute Lymphoblastic Leukemia",[478,479,480,481,482],"obesity","leukemia","B-cell leukemia","Pediatric obesity","Pediatric ALL",{"date":244,"type":35},{"date":485,"type":35},"2022-03-12",{"date":487,"type":21},"2032-08-15",{"name":489,"class":186},"Etan Orgel",16,{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":4,"eligibilityCriteria":497,"healthyVolunteers":195,"sex":310,"minAge":498,"maxAge":172,"enrollmentInfo":499,"targetDuration":4,"studyType":55,"phases":501,"briefSummary":503,"conditions":504,"keywords":506,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":43},"100609735","phase-4-the-effect-of-tirzepatide-on-menopausal-vasomotor-symptoms-and-biological-aging-in-post-menopausal-women-with-obesity-100609735","NCT07218445","The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity","The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity: A Pilot Study","Inclusion Criteria\n\n1. Females\n2. Age 46-60 years old.\n3. BMI ≥30 kg\u002Fm2 or BMI ≥27 kg\u002Fm2 in the presence of adiposity-associated diseases (hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease).\n4. Presence of bothersome hot flashes (an average of ≥ 28 episodes during a consecutive 2-week period with symptom severity sufficient to have prompted the participant to seek therapeutic treatment).\n5. Hot flashes must be present for \\>30 days prior to study entry.\n6. Willingness to self-inject drug\n7. Provided informed consent to be part of the study.\n8. Willingness and capability to follow an individualized hypocaloric diet designed to achieve an approximate energy deficit of 500 kcal\u002Fday relative to estimated total daily energy requirements. Daily energy requirements will be calculated using Harris-Benedict equation to estimate resting energy expenditure and multiplied by a sedentary physical activity factor of 1.2. Prescribed daily caloric intake will not be less than 1,000 kcal\u002Fday. Participants must also be willing to engage in at least 150 minutes per week of moderate-intensity or greater physical activity.\n\nExclusion Criteria\n\n1. Current or recent use (past 4 weeks) treatment with menopausal hormone therapy.\n2. Any current, recent use (past 4 weeks), or planned use of:\n\n   1. Estrogen-containing contraceptive methods or menopausal hormone therapy (oral, transdermal, high dose vaginal ring, injection, pellets).\n   2. Vaginal estrogen.\n   3. Androgens.\n   4. Progestogens.\n3. Current or recent use (past 4 weeks) treatment for menopausal symptoms with cognitive behavioral therapy and\u002For hypnosis.\n4. Current or recent use (past 4 weeks) of fezolinetant or elinzanetant.\n5. Menopause as a result of cancer treatments.\n6. Impaired renal function (GFR ≤30 ml\u002Fmin\u002F1.73 m²).\n7. Thyroid-stimulating hormone ≥7 with low free T4.\n8. 10-year ASCVD risk \\> 7.5%.\n9. Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignancy, or uncontrolled psychiatric disease.\n10. \\>5% change in weight during the 3 months prior to screening and, or eight fluctuation of ≥20 pounds within the past 6 months (self-report).\n11. Other obesity medication was used within the past 3 months.\n12. History of bariatric surgery. Prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty performed \\> 1 year before screening).\n13. Past or intended endoscopic and\u002For device-based therapy or removal within last six months.\n14. Use of weight gain-promoting medications (including tricyclic antidepressants, atypical antipsychotics, and mood stabilizers), unless the participant has been receiving the medication at a stable dose for ≥3 months prior to enrollment and has maintained a stable body weight during that time\n15. Current or recent (within 3 months) use of chronic systemic glucocorticoid therapy for over 2 weeks within the past 3 months.\n16. Female who is pregnant, breastfeeding, or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.\n17. Contraindications to GLP-1 receptor agonist therapy as per Tirzepatide (Zepbound ®) label, including a personal or family history of medullary thyroid carcinoma; a history or diagnosis of multiple endocrine neoplasia syndrome type 2; known hypersensitivity to tirzepatide or any of its excipients.\n18. Currently enrolled in another clinical study involving an investigational product or participated in one and received treatment (active or placebo) in the last 30 days.\n19. Planned surgical procedures requiring general anesthesia or sedation during the study or within 2 weeks following the last dose of study drug.","46 Years",{"count":500,"type":21},40,[502],"PHASE4","The purpose of this study is to determine the effect of tirzepatide on vasomotor symptoms and on measures of biological aging.",[25,505],"Menopause Hot Flashes",[507,508,509,510],"Hot flashes","menopause","Tirzepatide","GLP","2026-08-16",{"date":273,"type":35},{"date":514,"type":35},"2026-04-08",{"date":516,"type":21},"2027-09-18",{"name":518,"class":186},"Mayo Clinic",{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":523,"acronym":4,"eligibilityCriteria":524,"healthyVolunteers":195,"sex":16,"minAge":52,"maxAge":525,"enrollmentInfo":526,"targetDuration":4,"studyType":55,"phases":528,"briefSummary":529,"conditions":530,"keywords":532,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":43},"100533264","variability-in-mixed-meal-tests-fixed-versus-adjusted-to-energy-needs-caloric-dose-100533264","NCT06223555","Variability In Mixed Meal Tests: Fixed Versus Adjusted to Energy Needs Caloric Dose","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Provision of signed and dated informed consent form.\n* Agreement to adhere to Lifestyle Considerations throughout study duration.\n* Males and females; Age \\>= 18years\n* Healthy, as determined by medical history, physical examination, and laboratory tests.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this\n\nstudy:\n\n* Current use of medications, dietary supplements, or alternative therapies known to alter energy metabolism.\n* Fasting plasma glucose \\>= 126 mg\u002FdL\n* Type I or Type II Diabetes Mellitus by self-report.\n* Hematologic disorders including significant anemia (male hemoglobin \\\u003C 13.0 g\u002FdL or female hemoglobin \\\u003C 11.0 g\u002FdL)\n* Current pregnancy, pregnancy within the past 6 months or currently lactating\n* History or self-report of gastrointestinal disease, including inflammatory bowel diseases (e.g. Chron s disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active) which may alter metabolism or absorption of study food by self-report\n* Evidence of alcohol abuse as defined by an 8-point score on the Alcohol consumption screening AUDIT questionnaire in adults.\n* Participants who report taking large doses of acetaminophen (\\> 3 grams daily) who cannot stop acetaminophen 24 hours prior to and following the meal tests will be excluded from the study.\n* Inability to consume provided food based on a food allergy or intolerance.\n* Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators.\n* Any disorder, unwillingness, or inability not covered by any other exclusion criteria which, in the investigator s and\u002For team s opinion, jeopardizes the safety of the participant or others or would interfere with adherence to the protocol (such as claustrophobia).\n\nConditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators.","99 Years",{"count":527,"type":21},79,[176],"Background:\n\nResearchers use mixed meal tolerance tests (MMTTs) to look at how people s bodies respond to eating a meal. However, researchers do not agree on how to decide the number of calories to give in each meal. Some use fixed meals, which are the same size for everyone, and some use adjusted meals, based on the size of the person s body. Researchers want to know which MMTT is best to use for future research.\n\nObjective:\n\nTo learn how fixed vs adjusted meals affect blood glucose levels in healthy people.\n\nEligibility:\n\nHealthy people aged 18 years or older.\n\nDesign:\n\nParticipants will have 3 or 4 clinic visits of up to 8 hours in 8 weeks.\n\nParticipants will have baseline tests:\n\nTheir height, weight, and waist size will be measured.\n\nThey will have an oral glucose tolerance test: A needle attached to a tube (IV) will be inserted into a vein in the arm. They will have a sugary drink. Blood samples will be taken from the tube at intervals up to 3 hours after the drink.\n\nThey will have a body scan.\n\nParticipants will have 2 MMTT visits. One will include a fixed meal and one will include an adjusted meal. They will have tests at both visits:\n\nResting metabolic rate: A clear hood will be placed over the participant s head while they rest for 20 minutes. This will measure the oxygen they breathe in and out.\n\nMMTT. Participants will have 5 minutes to drink a liquid meal. Blood samples will be taken at intervals for the next 4 hours....",[25,531],"Healthy Volunteer",[531,25,533,534,535,536],"Body Composition","Diet","Mixed Meal Test","Glucose","2026-08-15",{"date":273,"type":35},{"date":540,"type":35},"2024-08-23",{"date":542,"type":21},"2027-12-31",{"name":96,"class":42},{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":16,"minAge":18,"maxAge":52,"enrollmentInfo":552,"targetDuration":4,"studyType":55,"phases":553,"briefSummary":554,"conditions":555,"keywords":557,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":561,"completionDateStruct":562,"leadSponsor":564,"locationsCount":43},"100652277","phase-4-semaglutide-in-youth-with-autism-spectrum-disorder-100652277","NCT07770152","Semaglutide in Youth With Autism Spectrum Disorder","Semaglutide for Metabolic and Adiposity-Related Targets in Youth With Autism Spectrum Disorder (SMART-ASD)","GLP1","Inclusion Criteria (Semaglutide Group):\n\n* 12-18 years of age\n* Epic-confirmed diagnosis of ASD\n* Obesity defined as BMI ≥95th percentile for age and sex\n* Have Medicaid or other insurance that will cover semaglutide or the parent is willing to pay for semaglutide out of pocket\n* Have a parent who is willing to provide informed consent\n* Can attend in-person, e-visits, or telehealth visits for 12 months\n* English speaking\n\nExclusion Criteria (Semaglutide Group):\n\n* Healthworks patient who has lost \\>5% body weight over the past 3 months\n* Are on a weight loss-promoting medication such as Metformin or Topamax with a dose change in the past 3 months\n* Have Type 1 or Type 2 diabetes\n* Have a personal or first-degree family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia 2\n* Have been on GLP-1 RAs in the past 12 months\n* Have significant GI conditions (e.g., pancreatitis),\n* Are pregnant or breastfeeding\n* Have catatonia or a condition that may affect compliance and safety\n\nInclusion Criteria (Historical Control Group):\n\n* Healthworks patients treated between January 1, 2021-December 31, 2025\n* 12-18 years of age\n* Confirmed diagnosis of ASD\n* Have obesity defined as BMI ≥95th percentile for age and sex\n* Have BMI and SMM outcomes assessed at M0, M6, or M12\n* Age groups 12-14 years old and 15-18 years old and sex matched to youth in the semaglutide group",{"count":163,"type":21},[502],"This study is a 6-month, two-arm, RCT which will evaluate the effectiveness and safety of semaglutide in adolescents aged 12-18 years with autism spectrum disorder (ASD) and obesity. The primary outcome is change in body mass index (BMI, kg\u002Fm²) from baseline to Month 6. Secondary, descriptive outcomes are changes in metabolic parameters (e.g., lipid levels), side effects, and compliance with semaglutide.",[556,25],"Autism Spectrum Disorder",[556,25,558],"Semaglutide","2026-08-14",{"date":273,"type":35},{"date":377,"type":21},{"date":563,"type":21},"2029-09-01",{"name":565,"class":186},"Children's Hospital Medical Center, Cincinnati",{"id":567,"slug":568,"hasResults":12,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":4,"eligibilityCriteria":572,"healthyVolunteers":195,"sex":16,"minAge":52,"maxAge":80,"enrollmentInfo":573,"targetDuration":4,"studyType":55,"phases":574,"briefSummary":575,"conditions":576,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":577,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":43},"100647600","phase-1-a-research-study-on-how-ubt251-affects-levels-of-midazolam-caffeine-and-warfarin-in-the-blood-of-participants-with-excess-body-weight-100647600","NCT07710768","A Research Study on How UBT251 Affects Levels of Midazolam, Caffeine and Warfarin in the Blood of Participants With Excess Body Weight","An Open-label, Single-sequence, Crossover Study Investigating the Influence of UBT251 on Pharmacokinetics of Index Substrates for Cytochrome P450 Enzymes in Participants With Overweight or Obesity","Inclusion Criteria:\n\n* Male or female (sex assigned at birth, inclusive of all gender identities).\n* Age 18-65 years (both inclusive) at the time of signing the informed consent.\n* BMI between 27.0-39.9 kg\u002Fm\\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.\n* Body weight \\>=60.0 kg.\n* Considered to be generally healthy, except for overweight or obesity, based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to study intervention(s) or related products.\n* Treatment with any marketed product containing compounds with glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), or glucagon (GCG) receptor agonism within 90 days before screening.\n* Use of prescription medicinal products or non-prescription drugs, including any herbal medicine known to interfere with the metabolic CYP pathways, such as perikon (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days (or within 5 half-lives of the medicinal product, whichever is longest) of screening, with the exception of use of routine vitamins (vitamins used within a normal dose reference interval), occasional use of acetaminophen, ibuprofen, or topical medication not reaching systemic circulation.\n* Any contraindications for the use of caffeine, midazolam, and warfarin used in the study according to Vivarin®, Midazolam®, and warfarin sodium product information.\n* Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, or as judged by the investigator.\n* History of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant.",{"count":391,"type":21},[292],"The purpose of this clinical study is to find out if UBT251 is safe and effective to be taken together with medicines, like midazolam, caffeine and warfarin in participants living with overweight or obesity.",[25,60],{"date":273,"type":35},{"date":579,"type":35},"2026-07-15",{"date":581,"type":21},"2027-04-07",{"name":419,"class":71},{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":589,"eligibilityCriteria":590,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":591,"targetDuration":4,"studyType":55,"phases":593,"briefSummary":594,"conditions":595,"keywords":602,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":605,"startDateStruct":606,"completionDateStruct":607,"leadSponsor":609,"locationsCount":611},"100642828","phase-2-a-study-of-pf-08653945-and-pf-08653944-in-adults-with-overweight-or-obesity-solis-1-100642828","NCT07575932","A Study of PF-08653945 and PF-08653944 in Adults With Overweight or Obesity (SOLIS-1)","A PHASE 2B, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, DOSE RANGING, DOSE-FINDING, UMBRELLA STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08653945 AND PF-08653944, ALONE OR IN COMBINATION, IN ADULTS WITH OVERWEIGHT OR OBESITY (SOLIS-1)","SOLIS-1","Inclusion Criteria:\n\nEligible participants for this study include:\n\n* adults aged 18 years or older with\n* obesity (BMI of 30.0 kg\u002Fm2 to 50.0 kg\u002Fm2) or with\n* overweight (BMI of 27.0 kg\u002Fm2 to \\\u003C30.0 kg\u002Fm2) who also have at least 1 prespecified weight-related comorbidity (hypertension, dyslipidemia, cardiovascular disease, or obstructive sleep apnea), at the screening visit.\n\nExclusion Criteria:\n\nParticipants who are not eligible include those with diabetes mellitus, a body weight change of \\>5% or use of weight loss medications in the 12 weeks prior to screening, a history of or plan for surgical treatment for obesity, and those who are unable or unwilling to comply with contraceptive requirements or are pregnant or lactating.",{"count":592,"type":21},872,[150],"This study is being done to learn about the safety and effects of the study drugs, PF-08653945 and PF-08653944, when given alone or together for weight loss, compared to a placebo (a dummy drug that has no active ingredient in it).",[60,25,596,597,598,599,600,601],"Overweight and\u002For Obesity","Overweight or Obesity","Overnutrition","Nutrition Disorders","Nutritional and Metabolic Diseases","Body Weight",[598,599,600,601,25,60,603,156,604],"GLP-1RA","DACRA",{"date":349,"type":35},{"date":436,"type":35},{"date":608,"type":21},"2028-01-05",{"name":610,"class":71},"Pfizer",65]