[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657393":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":40,"studyPopulation":40,"armGroups":52,"interventions":69,"overallOfficials":40,"centralContacts":79,"locations":85,"responsibleParty":292,"collaborators":40,"id":294,"slug":295,"hasResults":296,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":300,"eligibilityCriteria":301,"healthyVolunteers":296,"sex":302,"minAge":303,"maxAge":304,"enrollmentInfo":305,"targetDuration":40,"studyType":308,"phases":309,"briefSummary":311,"conditions":312,"keywords":40,"overallStatus":88,"whyStopped":40,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":324},{"fullName":5,"class":6},"Alveus Therapeutics, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":40},[9],{"measure":10,"description":11,"timeFrame":12},"Dose response of ALV-100 as assessed by maintenance of weight loss","Percentage change from baseline to Week 24 in BW","24 weeks",[14,18,22,25,28,31,34,37],{"measure":15,"description":16,"timeFrame":17},"Assess the safety and tolerability of ALV-100","Incidence of treatment emergent adverse events (TEAE) from first dose administration until Week 36","36 weeks",{"measure":19,"description":20,"timeFrame":21},"Efficacy of ALV-100 compared to placebo as assessed by maintenance of weight loss","Percentage change from baseline to week 24 and to Week 36 in Body Weight. Change from baseline to Week 24 and to Week 36 in BW (kg). Participants with a percentage change in BW from baseline to week 24 and to Week 36 of ≤3 %","24-36 weeks",{"measure":23,"description":24,"timeFrame":21},"Change from baseline in glycemic control parameters","Change from baseline in fasting glucose and hemoglobin A1c (HbA1c). Fasting glucose will be measured in mg\u002FdL or mmol\u002FL and HbA1c will be measured as percentage (%) or mmol\u002Fmol.",{"measure":26,"description":27,"timeFrame":21},"Change from baseline in lipid parameters","Change from baseline in total cholesterol, LDL-cholesterol, HDL-cholesterol, non-HDL-cholesterol, VLDL-cholesterol, triglycerides, and free fatty acids (FFA), measured in mg\u002FdL or mmol\u002FL.",{"measure":29,"description":30,"timeFrame":21},"Change from baseline in vital signs","Change from baseline in systolic and diastolic blood pressure, measured in mmHg.",{"measure":32,"description":33,"timeFrame":17},"Immunogenicity of ALV-100","Incidence of anti-drug antibodies (ADA) from baseline (pre-dose) until Week 36",{"measure":35,"description":36,"timeFrame":21},"Efficacy of ALV-100 versus placebo on subjective control of eating, food cravings, and mood-related eating behaviors as assessed by the Control of Eating Questionnaire (CoEQ)","Change from baseline in total and subscale scores of the Control of Eating Questionnaire (CoEQ) which is a 19-item patient-reported outcome measure that assesses aspects of eating behavior, including hunger, satiety, food cravings, craving control, and mood. Items are rated on an 11-point numeric rating scale from 0 to 10. The CoEQ includes four subscales: Craving Control (5 items), Positive Mood (4 items), Craving for Sweet Foods (4 items), and Craving for Savoury Foods (4 items), as well as single-item assessments of hunger and satiety. Subscale scores are calculated as the mean of the applicable item scores and range from 0 to 10. Higher Craving Control scores indicate greater control over food cravings, while higher craving scores indicate greater food cravings.",{"measure":38,"description":39,"timeFrame":21},"Effect of ALV-100 vs. placebo on food noise as assessed by the Food Noise Questionnaire (FNQ)","Change from baseline in total scores of the FOOD Noise Questionnaire (FNQ). The Food Noise Questionnaire (FNQ) is a 5-item patient-reported outcome measure designed to assess persistent and intrusive thoughts about food that may interfere with daily life. Each item is rated on a 5-point Likert scale from 0 (strongly disagree) to 4 (strongly agree). The total score is calculated by summing the responses to the 5 items and ranges from 0 to 20. Higher scores indicate greater levels of food noise.",null,{"allocation":42,"interventionModel":43,"interventionModelDescription":40,"primaryPurpose":44,"observationalModel":40,"timePerspective":40,"maskingInfo":45},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":46,"maskingDescription":40,"whoMasked":47},"QUADRUPLE",[48,49,50,51],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[53,60,63,66],{"label":54,"type":55,"description":56,"interventionNames":57},"Dose A - Schedule 1","EXPERIMENTAL","Participants will receive ALV-100 or volume matched placebo during the treatment period",[58,59],"Drug: ALV-100","Drug: Placebo",{"label":61,"type":55,"description":56,"interventionNames":62},"Dose B - Schedule 1",[58,59],{"label":64,"type":55,"description":56,"interventionNames":65},"Dose C - Schedule 1",[58,59],{"label":67,"type":55,"description":56,"interventionNames":68},"Dose A - Schedule 2",[58,59],[70,75],{"type":71,"name":72,"description":73,"armGroupLabels":74,"otherNames":40},"DRUG","ALV-100","Experimental drug",[54,67,61,64],{"type":71,"name":76,"description":77,"armGroupLabels":78,"otherNames":40},"Placebo","Volume matched placebo",[54,67,61,64],[80],{"name":81,"role":82,"phone":83,"phoneExt":40,"email":84},"Study Director","CONTACT","+1 215-607-2243","clinicaltrials@alveustx.com",[86,108,125,142,159,176,194,210,225,242,260,276],{"facility":87,"status":88,"city":89,"state":90,"zip":91,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":100},"University of Alabama - Birmingham","RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":95,"coordinates":96},"Point",[97,98],-86.80249,33.52066,{"lat":98,"lon":97},[101,105],{"name":102,"role":82,"phone":103,"phoneExt":40,"email":104},"Shruti Sukhanandi","205-934-4980","sbsukhan@uab.edu",{"name":106,"role":107,"phone":40,"phoneExt":40,"email":40},"Garvey, MD","PRINCIPAL_INVESTIGATOR",{"facility":109,"status":88,"city":110,"state":111,"zip":112,"country":92,"countryCode":93,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"AMR Clinical","Tempe","Arizona","85281",{"type":95,"coordinates":114},[115,116],-111.90931,33.41477,{"lat":116,"lon":115},[119,123],{"name":120,"role":82,"phone":121,"phoneExt":40,"email":122},"Sandy Quintanilla","602-910-3343","sandy.quintanilla@amr-clinical.com",{"name":124,"role":107,"phone":40,"phoneExt":40,"email":40},"Reedy, MD",{"facility":126,"status":88,"city":127,"state":128,"zip":129,"country":92,"countryCode":93,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Profound Research","Oceanside","California","92058",{"type":95,"coordinates":131},[132,133],-117.37948,33.19587,{"lat":133,"lon":132},[136,140],{"name":137,"role":82,"phone":138,"phoneExt":40,"email":139},"Christina Spencer","760-826-2020","Christina.Spencer@profoundresearch.com",{"name":141,"role":107,"phone":40,"phoneExt":40,"email":40},"Lizotte, DO",{"facility":143,"status":88,"city":144,"state":145,"zip":146,"country":92,"countryCode":93,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Clinical Neuroscience Solutions","Orlando","Florida","32801",{"type":95,"coordinates":148},[149,150],-81.37924,28.53834,{"lat":150,"lon":149},[153,157],{"name":154,"role":82,"phone":155,"phoneExt":40,"email":156},"Marla Graddic","407-425-5100","marla.graddic@cnshealthcare.com",{"name":158,"role":107,"phone":40,"phoneExt":40,"email":40},"Miroshnikova, MD",{"facility":160,"status":88,"city":161,"state":162,"zip":163,"country":92,"countryCode":93,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Christie Clinic","Champaign","Illinois","61822",{"type":95,"coordinates":165},[166,167],-88.24338,40.11642,{"lat":167,"lon":166},[170,174],{"name":171,"role":82,"phone":172,"phoneExt":40,"email":173},"Sarah Berlatsky","217-366-4003","slberlatsky@christieclinic.com",{"name":175,"role":107,"phone":40,"phoneExt":40,"email":40},"McCormick, DO",{"facility":177,"status":88,"city":178,"state":179,"zip":180,"country":92,"countryCode":93,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"BRCR Global Louisiana","Gretna","Louisiana","70053",{"type":95,"coordinates":182},[183,184],-90.05396,29.91465,{"lat":184,"lon":183},[187,192],{"name":188,"role":82,"phone":189,"phoneExt":190,"email":191},"Fernando Del Angel","561-447-0614","300","fdelangel@brcrglobal.com",{"name":193,"role":107,"phone":40,"phoneExt":40,"email":40},"Nguyen, MD",{"facility":126,"status":88,"city":195,"state":196,"zip":197,"country":92,"countryCode":93,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"Farmington Hills","Michigan","48334",{"type":95,"coordinates":199},[200,201],-83.37716,42.48531,{"lat":201,"lon":200},[204,208],{"name":205,"role":82,"phone":206,"phoneExt":40,"email":207},"Recruitment Lead","248-282-3640","recruitmentleads@profoundresearch.com",{"name":209,"role":107,"phone":40,"phoneExt":40,"email":40},"Schmeltz, MD",{"facility":211,"status":88,"city":212,"state":212,"zip":213,"country":92,"countryCode":93,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"ALSA Research-Manhattan","New York","10016",{"type":95,"coordinates":215},[216,217],-74.00597,40.71427,{"lat":217,"lon":216},[220,223],{"name":211,"role":82,"phone":221,"phoneExt":40,"email":222},"646-395-8175","sstein@alsaresearch.com",{"name":224,"role":107,"phone":40,"phoneExt":40,"email":40},"Bhatt, MD",{"facility":226,"status":88,"city":227,"state":228,"zip":229,"country":92,"countryCode":93,"cosmosGeoPoint":230,"geoPoint":234,"contacts":235},"TMA Headlands","Wilmington","North Carolina","28403",{"type":95,"coordinates":231},[232,233],-77.94604,34.23556,{"lat":233,"lon":232},[236,240],{"name":237,"role":82,"phone":238,"phoneExt":40,"email":239},"Megan Crouch","910-406-2268","megan.crouch@headlandsresearch.com",{"name":241,"role":107,"phone":40,"phoneExt":40,"email":40},"Jones, MD",{"facility":243,"status":88,"city":244,"state":245,"zip":246,"country":92,"countryCode":93,"cosmosGeoPoint":247,"geoPoint":251,"contacts":252},"Lynn Health Science Institute","Oklahoma City","Oklahoma","73112",{"type":95,"coordinates":248},[249,250],-97.51643,35.46756,{"lat":250,"lon":249},[253,258],{"name":254,"role":82,"phone":255,"phoneExt":256,"email":257},"Lacey Dietz","405-602-3939","118","ldietz@lhsi.net",{"name":259,"role":107,"phone":40,"phoneExt":40,"email":40},"Griffin, MD",{"facility":109,"status":88,"city":261,"state":262,"zip":263,"country":92,"countryCode":93,"cosmosGeoPoint":264,"geoPoint":268,"contacts":269},"Nashville","Tennessee","37203",{"type":95,"coordinates":265},[266,267],-86.78444,36.16589,{"lat":267,"lon":266},[270,274],{"name":271,"role":82,"phone":272,"phoneExt":40,"email":273},"John Viselli","615-334-9150","john.viselli@amr-clinical.com",{"name":275,"role":107,"phone":40,"phoneExt":40,"email":40},"Bowles, MD, PC",{"facility":109,"status":88,"city":277,"state":278,"zip":279,"country":92,"countryCode":93,"cosmosGeoPoint":280,"geoPoint":284,"contacts":285},"South Jordan","Utah","84095",{"type":95,"coordinates":281},[282,283],-111.92966,40.56217,{"lat":283,"lon":282},[286,290],{"name":287,"role":82,"phone":288,"phoneExt":40,"email":289},"Kate Aragundi","801-500-3399","Kate.aragundi@amr-clinical.com",{"name":291,"role":107,"phone":40,"phoneExt":40,"email":40},"Andrews, DO",{"type":293,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100657393","phase-2-study-to-assess-the-effect-and-safety-of-alv-100-on-maintenance-of-weight-loss-100657393",false,"NCT07837973","Study to Assess the Effect and Safety of ALV-100 on Maintenance of Weight Loss","A Double-Blind, Randomized, Multi-Center, Dose-Ranging, Phase 2 Study of the Efficacy and Safety of ALV-100 Versus Placebo for Maintenance of Weight Loss in Patients Previously Treated With Incretin-Based Therapies","PRESERVE","Key inclusion criteria\n\n1. Adult male and female participants, aged ≥18 to ≤75\n2. BMI ≥27 kg\u002Fm2 at screening.\n3. Has been treated with incretin-based therapy for weight management at a stable dose for at least 3 continuous months prior to screening.\n4. Tolerating incretin-based therapy at the discretion of the investigator\n5. WL of at least 10% while on incretin-based therapy and with stable BW for at least 3 months prior to screening.\n6. Willing to maintain their current general diet and physical activity regimen throughout the study.\n\nKey exclusion criteria\n\n1. Lifetime history of Type 1 or Type 2 diabetes\n2. Prior obesity treatment with surgery or a weight loss device.\n3. Obesity caused by known endocrinologic disorders or by known congenital or acquired hypothalamic disease or monogenetic or syndromic forms of obesity.\n4. Current or history of (within 3 months prior to screening) treatment with medications that may cause significant weight gain.\n5. Family or personal history of MTC or MEN 2\n6. Presence or history of malignant neoplasms within the past 5 years prior to screening","ALL","18 Years","75 Years",{"count":306,"type":307},220,"ESTIMATED","INTERVENTIONAL",[310],"PHASE2","A study of ALV-100 to assess efficacy, safety and tolerability among participants with overweight or obesity who have previously achieved a body weight reduction of ≥10% while treated with incretin-based therapies.",[313,314],"Overweight , Obesity","Adults","2026-09-24",{"date":317,"type":318},"2026-09-28","ACTUAL",{"date":320,"type":318},"2026-08-10",{"date":322,"type":307},"2027-08-24",{"name":5,"class":6},12]