[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"overweight\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:overweight":35},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,125,0,25,[9,53,82,107,124,155,175,185,195,217,236,266,292,303,321,340,361,383,402,421,443,463,483,504,526],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":36,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":4},"100053567","early-phase-1-team-based-shared-decision-making-program-in-cardiovascular-kidney-metabolic-health-100053567",false,"NCT07662616","Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health","Feasibility and Efficacy Pilot of a Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health, Medication Adherence, and Cardiovascular Health","SDM in CKM","Inclusion Criteria:\n\n* Are adults aged 30 to 79 years (to use PREVENT equations to calculate 10- and 30-year risk estimates for total CVD),\n* Are in stage 2 CKM: the presence of metabolic risk factors (hypertension \\[stages 1 and 2\\], hypertriglyceridemia \\[≥135 mg\u002FdL\\], diabetes, Metabolic Equivalents (MetS)\\*) and\u002For Chronic Kidney Disease (CKD) \\[moderate- to high-risk CKD which are stages 1-3 CKD\\]), and\n* Receive primary care at Johns Hopkins Community Physicians (JHCP).\n* Access to smart phone or tablet to use app.\n\nExclusion Criteria:\n\n* Have diagnosis of CVD,\n* Stage 4-5 CKD, kidney failure, or on dialysis\n* Have a serious medical condition such as cancer;\n* On or planning to start Glucagon-like peptide-1 (GLP-1) receptor agonists in next 6 months;\n* Have cognitive impairment;\n* Are currently involved in other programs on improving LE8; or\n* Unwillingness to provide informed consent\n* Unable to speak, read, or communicate in English.","ALL","30 Years","79 Years",{"count":22,"type":23},94,"ESTIMATED","INTERVENTIONAL",[26],"EARLY_PHASE1","The investigators are proposing a new team-based shared decision-making (SDM) program. The goal of this study is to see whether this program is practical and whether it may help adults with cardiometabolic risk factors and cardiovascular-kidney-metabolic syndrome. The investigators will enroll adults from a primary care clinic in Maryland. People in the intervention group will take part in the 6-month program in addition to usual care. People in the control group will receive usual care only.",[29,30,31,32,33,34,35],"Hypertension (HTN)","Diabetes (DM)","Hyperlipidaemia","Kidney Disease","Obesity","Cardiovascular-kidney-metabolic (CKM)","Overweight",[37,38,39,40],"shared decision-making","Cardiovascular-kidney-metabolic","Behavioral counseling","Team-based care","NOT_YET_RECRUITING","2026-07-10",{"date":44,"type":45},"2026-07-13","ACTUAL",{"date":47,"type":23},"2026-08-10",{"date":49,"type":23},"2028-06-30",{"name":51,"class":52},"Johns Hopkins University","OTHER",{"id":54,"slug":55,"hasResults":12,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":12,"sex":18,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":24,"phases":63,"briefSummary":65,"conditions":66,"keywords":67,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100053884","diet-order-effects-of-low-fat-vs-low-carb-diets-on-body-fat-change-100053884","NCT06325722","Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change","* INCLUSION CRITERIA:\n\nIn order to 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\n2. Adults aged 18-50 years\n3. Weight stable (\\\u003C +\u002F- 5% over past 6 months) as determined by volunteer report\n4. Body mass index (BMI) \\>= 25 kg\u002Fm\\^2\n5. Agreement to adhere to Lifestyle Considerations throughout the study duration\n\nEXCLUSION CRITERIA:\n\n1. Subjects with cardiac pacemakers or other implants that may be affected by or affect the DXA measurements\n2. Inadequate access to equipment required for the study (e.g., too little refrigerator storage space or a microwave oven that is too small) as determined by discretion of PI and\u002For study team\n3. Evidence of diseases or conditions that may influence appetite (e.g., cancer, diabetes, alterations of smell or taste post COVID-19), diseases or conditions that affect the immune system, or other conditions at the discretion of the PI and\u002For study team\n4. Taking prescription medications or other drugs that may influence metabolism (including but not limited to diet\u002Fweight-loss medication, some psychiatric medications, or other medications at the discretion of the PI and\u002For study team)\n5. People unlikely to adhere to a relatively consistent daily and weekly routine and avoid travel during their participation in the study. For example, people with occupations such as pilots, flight attendants, or frequently travel for work or pleasure.\n6. People unlikely to abstain from off study food or supplements that may impact metabolism or appetite at the discretion of the study team\n7. Positive pregnancy test or lactating as determined by volunteer report (women only)\n8. Inability or unwillingness to use birth control between screening and completion of the study (women only)\n9. Symptoms or signs of perimenopause or menopause by volunteer report (women only)\n10. Regular vigorous exercise \\>150 min per week as determined by volunteer report\n11. Alcohol consumption \\> 3 drinks per day as determined by volunteer report\n12. Regular use of tobacco (smoking, chewing, or vaping), nicotine replacement therapy, or illicit drugs over past 6 months as determined by volunteer report. Subjects may also be excluded based on a urine drug test.\n13. Psychological conditions as determined by DSM-5 Self-rated Level 1 Cross-cutting Symptom Measure such as (but not limited to) eating disorders, depression, bipolar disorders, that would be incompatible with safe and successful participation in this study, as determined by investigators\n14. Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies) or a reported dislike of a significant fraction of the study foods\n15. Volunteers unwilling or unable to give informed consent\n16. Non-English speakers due to unavailability of required questionnaires in other languages\n17. Resting Energy Expenditure test result within 10% of the 2500 calorie requirement at rest","18 Years","50 Years",{"count":62,"type":23},42,[64],"NA","Background:\n\nIn a previous study, participants were lived at the NIH and randomly received either a low-fat or a low-carbohydrate diet for 2 weeks and then switched to the other diet for 2 more weeks. Participants who received the low-carbohydrate diet first lost more body fat at the end of the study than those who received the low-fat diet first. Researchers want to see if they can repeat that result in a longer weight loss study when participants live at home.\n\nObjective:\n\nTo test the effects of diet order in people receiving either a low-fat or low-carbohydrate diet first for 4 weeks and then immediately switched to the other diet for another 4 weeks.\n\nEligibility:\n\nAdults aged 19 to 50 years with a body mass index of 25 or more.\n\nDesign:\n\nParticipants will complete the study at their homes, but there will be 3 required visits to the NIH. Participants will drink a special type of water 2 weeks before the baseline NIH visit and collect urine samples at home to measure how many calories they burn. Before the diets begin, participants will visit the NIH for baseline testing when they will have a metabolism test while relaxing in a bed with a plastic hood over their head to collect the air they breathe out. They will have scans to measure their bone density and how much muscle and body fat they have. They will give stool, blood, and urine samples.\n\nParticipants will be asked to eat a specific diet for 4 weeks followed by a different diet for 4 weeks. All meals will be delivered to the participants' homes. They will eat only the foods delivered.\n\nParticipants will weigh themselves daily. They will wear a monitor to track their physical activity and a sensor to measure their glucose levels. They will prick their finger each morning to test a drop of blood for ketones. Participants will meet virtually as a group with the study team weekly. Participants will have two more NIH visits towards the end of each diet period....",[35,33],[68,69,70,71],"Diet","Body Fat","Nutrition","weight-loss","RECRUITING",{"date":44,"type":45},{"date":75,"type":45},"2024-08-28",{"date":77,"type":23},"2029-11-30",{"name":79,"class":80},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",1,{"id":83,"slug":84,"hasResults":12,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":12,"sex":18,"minAge":59,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":24,"phases":92,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":106},"100053553","phase-3-amaze-3-a-research-study-investigating-how-well-the-medicine-nnc0487-0111-helps-people-with-excess-body-weight-and-obstructive-sleep-apnoea-not-treated-with-positive-airway-pressure-lose-weight-and-improve-sleep-apnoea-100053553","NCT07571005","AMAZE 3: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea","Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure (AMAZE 3)","AMAZE 3","Key Inclusion Criteria:\n\n* Male or female (sex at birth)\n* Age 18 years or above at the time of signing informed consent\n* Previously diagnosed moderate-to-severe OSA with an AHI ≥ 15, as diagnosed with polysomnography (PSG), home sleep apnoea test (HSAT), or other method that meets local guidelines prior to screening\n\nKey Exclusion Criteria:\n\n* Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol\u002Fmol) as measured by the central laboratory at screening\n* History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records\n* Any planned or previous surgery within 90 days prior to screening for sleep apnoea, including septoplasty, turbinoplasty, or other ear, nose, and throat surgeries, including tonsillectomy and adenoidectomy\n* Significant craniofacial abnormalities that may affect breathing at baseline, for example Treacher Collins syndrome and Pierre Robin Sequence\n* Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonist (RA), dual GLP-1\u002Fgastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues before screening",{"count":91,"type":23},300,[93],"PHASE3","This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with excess body weight and obstructive sleep apnoea not treated with positive airway pressure lose weight and improve sleep apnoea. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111, (the treatment being tested) or Placebo (a treatment that has no active medicine in it) and which treatment participants get is decided by chance.",[33,35,96],"Obstructive Sleep Apnoea","2026-07-09",{"date":44,"type":45},{"date":100,"type":45},"2026-05-05",{"date":102,"type":23},"2028-10-04",{"name":104,"class":105},"Novo Nordisk A\u002FS","INDUSTRY",80,{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":89,"healthyVolunteers":12,"sex":18,"minAge":59,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":24,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":118,"startDateStruct":119,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},"100054210","phase-3-amaze-4-a-research-study-investigating-how-well-the-medicine-nnc0487-0111-helps-people-with-excess-body-weight-and-obstructive-sleep-apnoea-treated-with-positive-airway-pressure-lose-weight-and-improve-sleep-apnoea-100054210","NCT07571109","AMAZE 4: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea","Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Obstructive Sleep Apnoea Treated With Positive Airway Pressure (AMAZE 4)","AMAZE 4",{"count":91,"type":23},[93],"This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with overweight or obesity, and obstructive sleep apnoea treated with positive airway pressure. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111, (the treatment being tested) or Placebo (a treatment that has no active medicine in it) and which treatment participants get is decided by chance.",[33,35,96],{"date":44,"type":45},{"date":100,"type":45},{"date":121,"type":23},"2028-08-21",{"name":104,"class":105},92,{"id":125,"slug":126,"hasResults":12,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":12,"sex":131,"minAge":132,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":24,"phases":136,"briefSummary":138,"conditions":139,"keywords":140,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":154},"100633209","phase-1-effect-of-maridebart-cafraglutide-on-how-oral-contraceptives-are-absorbed-and-processed-in-the-body-in-postmenopausal-female-participants-living-with-overweight-or-obesity-100633209","NCT07523711","Effect of Maridebart Cafraglutide on How Oral Contraceptives Are Absorbed and Processed in the Body in Postmenopausal Female Participants Living With Overweight or Obesity","A Phase 1, Open-label Study to Assess the Effect of Maridebart Cafraglutide (AMG 133) on the Pharmacokinetics of Oral Contraceptives in Postmenopausal Female Participants Living With Overweight or Obesity","Inclusion Criteria\n\n1. Participants must be postmenopausal females 45 to 65 years of age. Postmenopausal status must be confirmed based on the protocol-defined criteria.\n2. Body mass index must be ≥ 25.0 and ≤ 38.0 kg\u002Fm\\^2.\n3. Body weight must be stable, with less than 5 kg self-reported change in the 3 months before screening.\n4. Participants must not have changed their diet or started a nutritional lifestyle modification program within 3 months before screening.\n5. Other inclusion criteria may apply.\n\nExclusion Criteria\n\n1. History or evidence of any clinically significant medical condition, abnormal physical exam, ECG, vital sign, or laboratory finding that could increase risk or interfere with study participation.\n2. History of diabetes, active diabetes, or hemoglobin A1c 6.5% or higher.\n3. Endocrine disorders that can cause obesity, such as Cushing's syndrome.\n4. History of acute or chronic pancreatitis within 1 year before check-in, pancreatic enzyme elevations greater than 2 times the upper limit of normal, or fasting triglycerides greater than 300 mg\u002FdL.\n5. Bleeding or clotting disorders, abnormal coagulation tests, or a history of venous or arterial blood clots or conditions that increase clot risk.\n6. LDL cholesterol greater than 159 mg\u002FdL.\n7. Migraine with aura, normal pressure hydrocephalus, or ischemic optic neuropathy.\n8. Malignancy within the past 5 years, except nonmelanoma skin cancer.\n9. Unexplained postmenopausal vaginal bleeding, untreated endometrial disease, or other gynecologic conditions that could worsen with estrogen\u002Fprogestin therapy.\n10. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2, or uncontrolled thyroid disease.\n11. Gastroparesis, inability to swallow oral medication, clinically important gastrointestinal disease, malabsorption, uncontrolled inflammatory bowel disease, certain gastrointestinal surgeries, or recent bariatric surgery.\n12. Clinically significant cardiovascular disease, clinically significant arrhythmia, long QT syndrome, QTcF greater than 470 msec, second- or third-degree atrioventricular block, or clinically important abnormal pulse rate or systolic blood pressure \\> 150 mmHg or \\\u003C 90 mmHg, diastolic blood pressure \\> 95 mmHg or \\\u003C 50 mmHg.\n13. Allergy, hypersensitivity, intolerance, or contraindication to maridebart cafraglutide, ethinyl estradiol, or orgestimate.\n14. Reduced kidney function with estimated glomerular filtration rate 60 mL\u002Fmin\u002F1.73 m\\^2 or lower, ALT or AST greater than 2 times the upper limit of normal, or a history of acute or chronic liver disease, hepatic adenoma, or hepatic carcinoma.\n15. Hemoglobin or hematocrit below the lower limit of normal.\n16. Positive HIV test, or positive hepatitis B surface antigen or hepatitis C antibody at screening.\n17. Lifetime history of suicide attempt, non-suicidal self-injury within 5 years, or unstable major depressive disorder or other severe psychiatric disorder within 2 years.\n18. Positive pregnancy test at screening or check-in.\n19. Recent use of medications that could affect study participation, including most prescription or over-the-counter medications, systemic hormone replacement therapy, certain contraceptive hormones, CYP enzyme inducers or inhibitors, GLP-1 receptor or GIP receptor agents, and nonpermitted herbal products, vitamins, or supplements.\n20. Recent participation in another investigational study, prior participation in this study, or prior exposure to maridebart cafraglutide.\n21. Tobacco or nicotine use within 3 months before check-in, positive cotinine test, history of alcoholism or drug abuse, positive alcohol or illicit drug testing, recent illicit drug use, or unwillingness to avoid illicit drugs or cannabinoids during the study.\n22. Recent blood, plasma, or platelet donation.\n23. Other exclusion criteria may apply.","FEMALE","45 Years","65 Years",{"count":135,"type":23},45,[137],"PHASE1","The primary objective of the trial is to evaluate the effect of maridebart cafraglutide on the pharmacokinetics (PK) of a combined oral contraceptive (COC) in postmenopausal female participants living with overweight or obesity.",[35,33],[141,142,143,144],"Maridebart Cafraglutide","AMG 133","Norgestimate","Ethinyl Estradiol","2026-06-30",{"date":147,"type":45},"2026-07-01",{"date":149,"type":45},"2026-04-09",{"date":151,"type":23},"2026-11-18",{"name":153,"class":105},"Amgen",3,{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":165,"phases":4,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":173,"locationsCount":81},"100645131","impact-of-overweight-obesity-and-lifestyle-changes-on-work-performance-and-well-being-in-medical-residents-100645131","NCT07677800","Impact of Overweight, Obesity, and Lifestyle Changes on Work Performance and Well-Being in Medical Residents","Observational Study on the Impact of Overweight and Obesity and Lifestyle Changes on Work Performance and Well-being","OBESIT-A","Inclusion Criteria:\n\n* Male and female medical residents (physicians in specialty training).\n* Actively working in hospital or university healthcare settings at the time of enrollment.\n* Willing and able to participate in baseline and 12-month follow-up assessments.\n* Provision of written informed consent for study participation and processing of personal data.\n\nExclusion Criteria:\n\n* Pregnancy at baseline or occurring during the follow-up period.\n* Presence of severe clinical conditions that significantly impair work ability or performance, including active cancer treatment, unstable cardiovascular disease, major neurological disorders, or diabetes mellitus.\n* Inability or unwillingness to complete study assessments.\n* Refusal or withdrawal of informed consent.",{"count":164,"type":23},600,"OBSERVATIONAL","The goal of this observational study is to evaluate the impact of overweight, obesity, and lifestyle changes on work performance, work ability, quality of life, and overall well-being in medical residents working in hospital and university settings. The main questions it aims to answer are:\n\n* Is overweight and obesity associated with reduced work productivity, including absenteeism, presenteeism, and perceived work ability?\n* Is overweight and obesity associated with lower health-related quality of life, psychological well-being, and worker well-being?\n* Do lifestyle improvements and clinically significant weight loss over a 12-month period lead to measurable improvements in work productivity, work ability, quality of life, and well-being?\n* Do changes in physical health, mental health, and organizational factors mediate the relationship between weight loss and occupational outcomes? Participants will undergo assessments at baseline and after 12 months of follow-up. Researchers will evaluate associations between body weight status, health outcomes, and occupational performance over time.\n\nParticipants will: Attend occupational health surveillance visits at baseline and at 12 months. Undergo anthropometric measurements, including body mass index (BMI), waist circumference, and blood pressure assessment.\n\nProvide blood samples for routine laboratory evaluation, including metabolic, cardiovascular, inflammatory, and hematological parameters.\n\nComplete validated questionnaires assessing health-related quality of life (SF-12), work ability (Work Ability Index), work productivity and activity impairment (WPAI), fatigue (Fatigue Severity Scale), psychological well-being (PGWBI), mental health (DASS-21), worker well-being (NIOSH WellBQ), and resilience (CD-RISC). Provide information on sociodemographic characteristics, lifestyle habits, medical history, occupational characteristics, and work-related exposures.\n\nThe study will estimate the prevalence of overweight and obesity in a cohort of medical residents and investigate their association with occupational and health-related outcomes. Longitudinal analyses will examine whether changes in lifestyle behaviors and body weight are associated with changes in productivity, absenteeism, presenteeism, work ability, quality of life, and well-being over a 12-month observation period. The study will also explore potential mechanisms linking weight status and occupational outcomes, including physical health, psychological health, and organizational factors.",[33,35],"2026-06-25",{"date":147,"type":45},{"date":171,"type":23},"2026-06-15",{"date":49,"type":23},{"name":174,"class":52},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":176,"slug":4,"hasResults":12,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":12,"sex":18,"minAge":59,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":24,"phases":178,"briefSummary":94,"conditions":179,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":183,"leadSponsor":184,"locationsCount":106},"100636847",{"count":91,"type":23},[93],[33,35,96],{"date":181,"type":45},"2026-06-26",{"date":100,"type":45},{"date":102,"type":23},{"name":104,"class":105},{"id":186,"slug":4,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":89,"healthyVolunteers":12,"sex":18,"minAge":59,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":24,"phases":188,"briefSummary":116,"conditions":189,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":193,"leadSponsor":194,"locationsCount":123},"100636855",{"count":91,"type":23},[93],[33,35,96],{"date":191,"type":45},"2026-06-29",{"date":100,"type":45},{"date":121,"type":23},{"name":104,"class":105},{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":18,"minAge":59,"maxAge":202,"enrollmentInfo":203,"targetDuration":4,"studyType":24,"phases":204,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":212,"leadSponsor":214,"locationsCount":216},"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":91,"type":23},[205],"PHASE2","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.",[33,35],"2026-06-23",{"date":210,"type":45},"2026-06-24",{"date":191,"type":23},{"date":213,"type":23},"2027-08-18",{"name":215,"class":105},"Boehringer Ingelheim",57,{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":18,"minAge":59,"maxAge":224,"enrollmentInfo":225,"targetDuration":4,"studyType":24,"phases":227,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":230,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":81},"100637732","phase-1-a-research-study-to-compare-blood-levels-of-cagrilintide-after-multiple-doses-of-different-versions-of-cagrilintide-in-adults-with-overweight-or-obesity-100637732","NCT07597018","A Research Study to Compare Blood Levels of Cagrilintide After Multiple Doses of Different Versions of Cagrilintide in Adults With Overweight or Obesity","Bioequivalence Study of Cagrilintide B + Placebo Semaglutide I and Cagrilintide D Once Weekly in Participants With Overweight or Obesity","Inclusion Criteria:\n\n* Aged 18-64 years (both inclusive) at the time of signing informed consent\n* Body mass index (BMI) between 27.0 and 34.9 kilograms per square metre (kg\u002Fm\\^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.\n* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), and clinical laboratory tests performed during the screening visit, as judged by the investigator.\n\nExclusion Criteria:\n\n* Previous participation in study(s) with an amylin analogue. Participation is defined as randomisation.\n* Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.","64 Years",{"count":226,"type":23},234,[137],"This clinical study is testing two versions of the study medicine cagrilintide. The purpose of the study is to compare these two versions to understand their effects in participants with overweight or obesity. Participants will receive either cagrilintide version D or cagrilintide version B, and which treatment participants receive is decided by chance. Participants will be in this clinical study for about 6 months.",[33,35],{"date":181,"type":45},{"date":232,"type":45},"2026-05-18",{"date":234,"type":23},"2027-06-01",{"name":104,"class":105},{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":243,"sex":18,"minAge":59,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":24,"phases":246,"briefSummary":247,"conditions":248,"keywords":249,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":257,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":265},"100563659","healthytogether-rct-of-a-dyadic-weight-management-intervention-100563659","NCT06619041","HealthyTogether: RCT of a Dyadic Weight Management Intervention","Harnessing the Power of Social Support for Weight Management: a Randomized Controlled Trial of HealthyTogether","Inclusion Criteria:\n\nVeteran participants:\n\n* Age 18 or higher.\n* Assigned to a VA primary care provider.\n* Have a weight measurement (BMI\\>=30) recorded in the VA medical record within 16 weeks prior to enrollment.\n* Have a second, valid weight measurement recorded in the VA medical record within the prior year.\n* Have a BMI\\>=30 at enrollment.\n* Able to participate in virtual intervention sessions during regular business hours.\n\nPartner participants:\n\n* Age 18 or higher.\n* Able to participate in virtual intervention sessions during regular business hours.\n* Speak with Veteran at last weekly.\n* Live in the same state where Veteran receives VA care.\n\nExclusion Criteria:\n\nVeterans are excluded if:\n\n* not fluent in English\n* have severe hearing loss prohibiting participation\n* have a dementia diagnosis\n* have recently (within the past 3 months) participated in a clinical or research behavioral weight management program\n* have a history of (within past 2 years) or plans to (within next 6 months) have bariatric surgery\n* are pregnant, postpartum, nursing, or planning to become pregnant within 6 months\n* are receiving cancer (non-skin) treatment\n* have drug or alcohol dependence not in remission, a recent suicide attempt, active psychosis, or an active behavior flag in the medical record\n* report high-levels of alcohol use (AUDIT-C score \\>=8)\n* are receiving hospice or palliative care\n* are living in a nursing home or assisted living facility\n* are enrolled in VA home-based primary care\n* have end stage renal disease\n* have a current or past diagnosis of anorexia or bulimia\n* have had an inpatient hospitalization in the past 3 months\n* weigh more than 440 pounds (this is the upper limit of the study's scales)\n\nPartners are excluded if:\n\n* not fluent in English\n* have severe hearing loss prohibiting participation\n* endorse having a health condition that may limit their ability to participate in the intervention\n* report high-levels of current alcohol use (AUDIT-C score \\>=8)\n* are receiving hospice or palliative care\n* are living in a nursing home or assisted living facility",true,{"count":245,"type":23},320,[64],"Four in five Veterans have overweight or obesity. However, few eligible Veterans achieve meaningful weight loss in VA's national MOVE! Weight Management Program. Family and friends strongly influence a person's health behaviors and weight. Including a close family member or friend in weight management may improve weight management outcomes. This study will test whether an 14-week, 8-session virtual weight management program that includes Veterans and a support person (e.g., family member or friend) leads to weight loss. The investigators will also test whether the program leads to improvements in weight-related health behaviors, including physical activity and diet, and relationship quality.",[33,35],[250,251,252,68,253,254,255,256],"Weight Loss","Weight Loss Programs","Social Support","Physical Activity","Virtual Medicine","Family","Dyadic",{"date":181,"type":45},{"date":259,"type":45},"2025-07-14",{"date":261,"type":23},"2028-09-30",{"name":263,"class":264},"VA Office of Research and Development","FED",2,{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":243,"sex":131,"minAge":59,"maxAge":272,"enrollmentInfo":273,"targetDuration":4,"studyType":24,"phases":275,"briefSummary":276,"conditions":277,"keywords":279,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":285,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":81},"100317012","phase-2-effects-of-sucralose-on-drug-absorption-and-metabolism-the-sweetmeds-study-100317012","NCT03407079","Effects of Sucralose on Drug Absorption and Metabolism (The SweetMeds Study)","* INCLUSION CRITERIA:\n\n  1. Age: between 18 and 60 years\n  2. Female adults who self-identify as Hispanic and\u002For Black\n  3. Body weight greater than 50 kg (110 lb)\n  4. Body mass index between 25 kg\u002Fm\\^2 and 40 kg\u002Fm\\^2\n  5. Consumption of less than or equal to one 12-ounce beverage sweetened with NNS per month or food equivalent\n  6. Healthy with no known active medical condition or illness that requires drug treatment\n  7. Able and willing to consume approximately 4 mg\u002Fkg sucralose daily or placebo in form of capsules for\n\n  4 weeks\n\n  8\\. Able and willing to avoid eating grapefruit, parsnips, celery, drinking grapefruit juice or sodas containing quinine (e.g. tonic water) during the study\n\n  9\\. Able and willing to collect stool specimens\n\n  10\\. Able and willing to consume digoxin and midazolam during study visits\n\nEXCLUSION CRITERIA:\n\n1. Current use of prescription or non-prescription medication(s), herbal medications and oral contraceptives are also excluded. Certain exceptions are permitted, including vitamins. Other medications may be permitted at the discretion of the investigators.\n2. Diabetes (fasting blood glucose of 126 mg\u002Fdl or higher, or 2-hour blood glucose of 200 or higher on OGTT)\n3. Taken medications that affect blood sugar in the past 3 months or that include antibiotics\n4. GI history, at the discretion of the investigators\n5. Known allergy, sensitivity, or other contraindication to study procedures\n6. ALT or AST more than 1.5 times the upper limit of normal\n7. Abnormal thyroid function or abnormal serum electrolytes \\& minerals (specifically potassium, calcium, and magnesium)\n8. Narrow angle glaucoma or untreated open angle glaucoma\n9. Regular use of alcohol (more than 1 drink per day) or drug use\n10. History of cardiac abnormalities, especially arrhythmia\n11. Unable or unwilling to cooperate with study procedures\n12. Psychiatric or cognitive disorder that will, in the opinion of the investigators, limit the subject's ability to provide informed consent, or to comply with study procedures\n13. Pregnant, planning to become pregnant or lactating (digoxin and midazolam are Category C and D medications, respectively).","60 Years",{"count":274,"type":23},150,[205],"Background:\n\nArtificial sweeteners like sucralose are found in many foods and drinks. Sucralose might affect hormones and cause health changes.\n\nObjective:\n\nTo see if sucralose changes how medicines are absorbed and processed, how hormones are secreted, gut bacteria, and how fat cells are metabolized.\n\nEligibility:\n\nPeople ages 18-60 who:\n\n* Are black or Hispanic\n* Weigh more than 110 pounds\n* Have a body mass index of 25-40\n* Do not have a condition that requires drug treatment\n\nDesign:\n\nParticipants will be screened with:\n\n* Medical history\n* Physical exam\n* Blood, heart, and urine tests\n\nParticipants must not eat or drink anything with artificial sweeteners throughout the study.\n\nOver 7 days, Participants will answer questions, and give daily urine samples and 1 stool sample. Participants will repeat these throughout the study.\n\nOvernight Visit 1: participants will fast starting the night before. They will get breakfast at the visit. The visit includes:\n\n* An IV will be placed in the arm. Participants will get 2 tablets of medicines. Blood will be drawn several times over 24 hours.\n* A piece of fat tissue may be taken from the abdomen (biopsy).\n* Participants will have a sweet drink. Blood samples will be taken over 2 hours.\n\nThen participants will be randomly assigned to take either a sucralose capsule or placebo. They will take it twice a day for 2 weeks. They will complete two 24-hour food diaries.\n\nOvernight Visit 2 repeats Visit 1 except the biopsy.\n\nThen participants will take the capsules for another 2 weeks.\n\nOvernight Visit 3 repeats Visit 1.\n\nParticipants may be contacted by phone within 4 weeks after they finish.",[278,35],"Healthy Volunteers",[280,281,282,283,284],"Drug Metabolism","Artificial Sweetener","P-Glycoprotein","Cytochrome P450","Microbiome",{"date":210,"type":45},{"date":287,"type":45},"2018-04-05",{"date":289,"type":23},"2027-12-26",{"name":291,"class":80},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)",{"id":293,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":294,"targetDuration":4,"studyType":24,"phases":295,"briefSummary":27,"conditions":296,"keywords":297,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":300,"completionDateStruct":301,"leadSponsor":302,"locationsCount":4},"100643950",{"count":22,"type":23},[26],[29,30,31,32,33,34,35],[37,38,39,40],"2026-06-22",{"date":168,"type":45},{"date":147,"type":23},{"date":49,"type":23},{"name":51,"class":52},{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":18,"minAge":59,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":24,"phases":311,"briefSummary":312,"conditions":313,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":315,"startDateStruct":316,"completionDateStruct":317,"leadSponsor":319,"locationsCount":154},"100644599","phase-3-a-study-to-evaluate-the-effects-of-enicepatide-in-participants-with-obesity-or-overweight-with-or-without-type-2-diabetes-100644599","NCT07670416","A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes","A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 in Adult Chinese Patients With Obesity or Overweight, With or Without Type 2 Diabetes Mellitus","Inclusion Criteria:\n\n* Body mass index (BMI) ≥24.0 kilograms per meter squared (kg\u002Fm\\^2) for participants with type 2 diabetes mellitus (T2DM)\n* BMI ≥28.0 kg\u002Fm\\^2 or BMI ≥24.0 and \\\u003C28.0 kg\u002Fm\\^2 and diagnosed with at least one weight-related comorbidity (prediabetes, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea, or weight-related cardiovascular disease) for participants without T2DM\n* Agreement to adhere to the contraception requirements\n\nExclusion Criteria:\n\n* History of Type 1 diabetes mellitus (T1DM)\n* Obesity induced by other endocrinologic disorders\n* Any planned major medical procedure or surgery during the study\n* History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder\n* Any lifetime history of suicide attempt\n* History of any hematologic conditions that may interfere with HbA1c measurement\n* History of acute or chronic pancreatitis or clinically significant gallbladder disease\n* Treatment with any approved or investigational GLP-1-RA-based therapy within 6 months prior to randomization\n* Treatment with other investigational therapy within 3 months prior to randomization or less than 5 elimination half-lives prior to randomization, whichever is longer\n* Known allergy to any component of the study drug formulation or any other condition that is a contraindication to GLP-1 RAs or GLP-1\u002FGIP RAs",{"count":91,"type":23},[93],"The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)\u002Fglucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA) being developed for chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity, and in participants with T2DM who have obesity or overweight.",[33,35,314],"Type 2 Diabetes Mellitus (T2DM)",{"date":181,"type":45},{"date":168,"type":23},{"date":318,"type":23},"2028-04-02",{"name":320,"class":105},"Hoffmann-La Roche",{"id":322,"slug":323,"hasResults":12,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":12,"sex":18,"minAge":59,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":24,"phases":330,"briefSummary":331,"conditions":332,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":333,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":339},"100640441","phase-1-evaluation-of-the-tolerability-of-cagrilintide-in-participants-not-tolerating-glp-1-ra-therapies-due-to-gastrointestinal-adverse-events-100640441","NCT07607587","Evaluation of the Tolerability of Cagrilintide in Participants Not Tolerating GLP-1-RA Therapies Due to Gastrointestinal Adverse Events","Tolerability of Cagrilintide in People With Obesity That Discontinued GLP-1-RA Therapies Due to Gastrointestinal Adverse Events: a Double-blinded Randomised Feasibility Study","Key Inclusion Criteria:\n\n* Male or female (sex at birth)\n* Age 18 years or above at the time of signing the informed consent\n* History of documented treatment with GLP-1-RA medications with gastrointestinal (GI) adverse effects as the main reason for treatment discontinuation\n* Not suitable for re-initiation of GLP-1-RA treatment based on medical history and investigator judgement\n* Body mass index (BMI) greater than or equal to (≥) 30.0 kilograms per square meter (kg\u002Fm\\^2)\n\nKey Exclusion Criteria:\n\n* Female who is pregnant, breast-feeding, or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive methods\n* Treatment with GLP-1 receptor agonist or GLP-1-RA medication for any indication within 8 weeks before screening\n* History of type 1 or type 2 diabetes\n* Glycated haemoglobin (HbA1c) ≥ 6.5 percent (%) (48 millimole per mole \\[mmol\u002Fmol\\]) as measured by the central laboratory at screening\n* Treatment with glucose-lowering agent(s) prescribed for the indication of diabetes or pre-diabetes within 90 days before screening\n* Treatment with any medication prescribed for the indication of weight management within 8 weeks before screening",{"count":329,"type":23},114,[137],"The purpose of this clinical study is to look at the safety of the medicine Cagrilintide when compared to placebo in people who do not tolerate marketed glucagon-like peptide-1 (GLP-1) therapies and who live with overweight or obesity. Participants will get either Cagrilintide (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participant will get is decided by chance. The study will last for about 8 months.",[33,35],{"date":168,"type":45},{"date":335,"type":45},"2026-05-29",{"date":337,"type":23},"2027-11-19",{"name":104,"class":105},11,{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":346,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":18,"minAge":59,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":24,"phases":350,"briefSummary":351,"conditions":352,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":360},"100643909","phase-3-a-research-study-investigating-how-well-the-medicine-zenagamtide-helps-people-with-excess-body-weight-lose-weight-compared-to-semaglutide-100643909","NCT07668414","A Research Study Investigating How Well the Medicine Zenagamtide Helps People With Excess Body Weight Lose Weight Compared to Semaglutide","Efficacy and Safety of Zenagamtide s.c. Once-weekly Compared to Semaglutide s.c. Once-weekly in Participants With Obesity (AMAZE 7)","AMAZE 7","Inclusion Criteria:\n\n* Male or female (sex at birth).\n* Age 18 years or above at the time of signing the informed consent.\n\nExclusion Criteria:\n\n* Glycated haemoglobin (HbA1c) ≥ 6.5% (48 millimoles per mole \\[mmol\u002Fmol\\]) as measured by the central laboratory at screening.\n* History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records.\n* Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1\u002Fgastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues within 1 year before screening.",{"count":349,"type":23},650,[93],"The purpose of this study is to find out if zenagamtide is safe and effective for treating participants who have excess body weight compared to treatment with semaglutide.",[35,33],"2026-06-19",{"date":168,"type":45},{"date":356,"type":23},"2026-09-22",{"date":358,"type":23},"2028-10-10",{"name":104,"class":105},46,{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":243,"sex":18,"minAge":59,"maxAge":368,"enrollmentInfo":369,"targetDuration":4,"studyType":24,"phases":371,"briefSummary":372,"conditions":373,"keywords":374,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":376,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":81},"100644108","phase-1-a-study-of-eloralintide-ly3841136-in-participants-with-overweight-or-obesity-100644108","NCT07665879","A Study of Eloralintide (LY3841136) in Participants With Overweight or Obesity","A Phase 1, Investigator- and Participant-Blinded Study to Evaluate the Effect of Eloralintide on Insulin Sensitivity and Metabolism in Adult Participants With Overweight or Obesity","Inclusion Criteria:\n\n* Have an hemoglobin A1c (HbA1c) value at screening of less than 6.5 percent (%).\n* Have a body mass index between 25 and 45 Kilogram per Square Meter (kg\u002Fm²).\n* Have had a stable body weight that has changed by less than 5% during the 3 months prior to screening.\n* Are individuals assigned male at birth (AMAB) or assigned female at birth (AFAB). Individuals of childbearing potential (IOCBP) and individuals not of childbearing potential (INOCBP) may participate in this study.\n\nExclusion Criteria:\n\n* Have type 1 or type 2 diabetes mellitus, a history of ketoacidosis, or of hyperosmolar state or coma. Note: Participants with a history of gestational diabetes are eligible to participate in this study.\n* Have acute or chronic pancreatitis or a history of acute idiopathic pancreatitis.\n* Have a known clinically significant gastric emptying abnormality or chronically take drugs that directly affect gastrointestinal (GI) motility to a significant extent.\n* Have a prior or planned surgical treatment for obesity. Exceptions: The following are allowed if they occurred more than 1 year before screening:\n\n  * liposuction\n  * cryolipolysis, or\n  * abdominoplasty.\n* Are unwilling to comply with the lifestyle and dietary restrictions required for this study.\n* Are individuals AFAB who are lactating.\n* Are individuals AFAB who are pregnant or intend to become pregnant or to breastfeed during the study, or individuals AMAB who intend to conceive a pregnancy during the study.","70 Years",{"count":370,"type":23},115,[137],"The main purpose of the study is to measure and compare the effects of eloralintide and placebo on insulin sensitivity (how your body responds to insulin), metabolic health (things like sugar and cholesterol), and body weight in participants with obesity or overweight. For each participant, the study will last about 35 weeks and include 3 in patient visits totaling 7 days.",[35,33],[375],"Healthy",{"date":210,"type":45},{"date":378,"type":23},"2026-06",{"date":380,"type":23},"2027-08",{"name":382,"class":105},"Eli Lilly and Company",{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":389,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":18,"minAge":59,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":24,"phases":393,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":396,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":339},"100643877","phase-3-amaze-13-a-research-study-investigating-how-well-the-medicine-zenagamtide-helps-people-in-asia-with-excess-body-weight-lose-weight-100643877","NCT07668401","AMAZE 13: A Research Study Investigating How Well the Medicine Zenagamtide Helps People in Asia With Excess Body Weight Lose Weight","Efficacy and Safety of Zenagamtide s.c. Once-weekly in Asian Participants With Overweight or Obesity (AMAZE 13)","AMAZE 13","Inclusion Criteria:\n\n* Male or female (sex assigned at birth, inclusive of all gender identities).\n* Age 18 years or above at the time of signing the informed consent\n\nExclusion Criteria:\n\n* Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol\u002Fmol) as measured by the central laboratory at screening.\n* History of type 1 or type 2 diabetes mellitus.\n* Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1\u002Fgastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues before screening.",{"count":392,"type":23},400,[93],"The purpose of this clinical study is to find out if zenagamtide is safe and effective for treating people who have excess body weight. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get zenagamtide (the treatment being tested) or placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.",[33,35],{"date":168,"type":45},{"date":398,"type":23},"2027-01-07",{"date":400,"type":23},"2029-01-11",{"name":104,"class":105},{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":18,"minAge":59,"maxAge":409,"enrollmentInfo":410,"targetDuration":4,"studyType":24,"phases":411,"briefSummary":412,"conditions":413,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":414,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":420},"100637375","phase-2-a-study-to-investigate-weight-management-with-macupatide-and-eloralintide-alone-or-in-combination-in-adult-participants-with-obesity-or-overweight-100637375","NCT07589608","A Study to Investigate Weight Management With Macupatide and Eloralintide, Alone or in Combination, in Adult Participants With Obesity or Overweight","A Phase 2b, Parallel-Group, Double-Blind, Placebo-Controlled Study to Investigate Weight Management With Macupatide and Eloralintide, Alone or in Combination, in Adult Participants With Obesity or Overweight and Without Type 2 Diabetes","Inclusion Criteria:\n\n* See Master Protocol CWMM (NCT06143956) for inclusion criteria\n\nExclusion Criteria:\n\nIn addition to exclusion criteria in Master Protocol CWMM (NCT06143956):\n\n* Have type 1 diabetes or type 2 diabetes\n* Have an ongoing history of bradyarrhythmia and\u002For sinus bradycardia\n* Have an elevated resting pulse rate (greater than 100 bpm) or reduced resting pulse rate (less than 60 bpm)\n* Have a history of acute or chronic pancreatitis\n* All concomitant medications should be at a stable dose for at least 3 months prior to screening","75 Years",{"count":392,"type":23},[205],"The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to examine the body weight-lowering efficacy and safety of macupatide plus eloralintide compared with placebo in participants with obesity or overweight and without type 2 diabetes. Participation will last about 64 weeks.",[35,33],{"date":210,"type":45},{"date":416,"type":45},"2026-05-15",{"date":418,"type":23},"2028-02",{"name":382,"class":105},40,{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":427,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":18,"minAge":59,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":24,"phases":431,"briefSummary":432,"conditions":433,"keywords":434,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":436,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":442},"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",{"count":430,"type":23},900,[93],"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.",[35,33],[435],"Amylin receptor agonist",{"date":208,"type":45},{"date":438,"type":45},"2026-02-10",{"date":440,"type":23},"2028-07",{"name":382,"class":105},183,{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":449,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":18,"minAge":59,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":24,"phases":453,"briefSummary":454,"conditions":455,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":457,"startDateStruct":458,"completionDateStruct":459,"leadSponsor":461,"locationsCount":462},"100621314","phase-3-a-study-of-eloralintide-ly3841136-in-participants-with-obstructive-sleep-apnea-and-obesity-or-overweight-100621314","NCT07369011","A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight","A Master Protocol for Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Moderate to Severe Obstructive Sleep Apnea, and Obesity or Overweight","ENLIGHTEN-3","Inclusion Criteria:\n\n* Confirmed history of moderate-to-severe OSA\n* Have an AHI ≥ 15 on polysomnography (PSG) as part of the study at screening\n* Have a BMI ≥27 kg\u002Fm2 at screening\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\nFor YSA1 Participants:\n\n* Are unable or unwilling to use PAP therapy\n\nFor YSA2 Participants:\n\n* Have been on PAP therapy for at least three consecutive months prior to screening and plan to continue PAP therapy during the study\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* Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery that still may affect breathing at time of screening\n* Have type 1 diabetes, type 2 diabetes, or any other type of diabetes\n* Have had within 90 days prior to screening:\n\n  * acute myocardial infarction\n  * cerebrovascular accident (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":452,"type":23},800,[93],"The purpose of the studies is to evaluate the efficacy and safety of eloralintide in participants with moderate-to-severe obstructive sleep apnea and obesity or overweight. YDAO is a master protocol designed to support two independent studies: YSA1 and YSA2. Study YSA1 will include participants who are unable or unwilling to use Positive Airway Pressure (PAP) therapy and study YSA2 will include participants who are on PAP therapy for at least 3 months at time of screening and plan to continue PAP therapy during the study.\n\nParticipants will be assigned to the Intervention-Specific Appendix (ISA) that reflects their current PAP usage. Participation in the study will last about 76 weeks.",[456,33,35],"Sleep Apnea, Obstructive",{"date":208,"type":45},{"date":438,"type":45},{"date":460,"type":23},"2028-04",{"name":382,"class":105},129,{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":469,"eligibilityCriteria":470,"healthyVolunteers":12,"sex":18,"minAge":59,"maxAge":4,"enrollmentInfo":471,"targetDuration":4,"studyType":24,"phases":473,"briefSummary":474,"conditions":475,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":476,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":482},"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":472,"type":23},1980,[93],"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.",[33,35],{"date":208,"type":45},{"date":478,"type":45},"2026-02-06",{"date":480,"type":23},"2030-07",{"name":382,"class":105},169,{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":489,"eligibilityCriteria":490,"healthyVolunteers":12,"sex":18,"minAge":59,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":24,"phases":493,"briefSummary":494,"conditions":495,"keywords":496,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":498,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":502,"locationsCount":503},"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":492,"type":23},1035,[93],"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.",[35,33],[497],"Type 2 Diabetes",{"date":208,"type":45},{"date":500,"type":45},"2025-12-15",{"date":418,"type":23},{"name":382,"class":105},159,{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":4,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":18,"minAge":59,"maxAge":409,"enrollmentInfo":511,"targetDuration":4,"studyType":24,"phases":513,"briefSummary":514,"conditions":515,"keywords":517,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":520,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":62},"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",{"count":512,"type":23},200,[205],"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.",[33,35,516],"Diabetes Mellitus, Type 2",[518,519],"GIP","Amylin",{"date":208,"type":45},{"date":522,"type":45},"2025-10-16",{"date":524,"type":23},"2027-05",{"name":382,"class":105},{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":4,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":18,"minAge":59,"maxAge":4,"enrollmentInfo":533,"targetDuration":4,"studyType":24,"phases":535,"briefSummary":536,"conditions":537,"keywords":539,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":542,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":154},"100593648","phase-2-study-to-evaluate-the-efficacy-and-safety-of-kds2010-in-overweight-or-obese-patients-100593648","NCT07009171","Study to Evaluate the Efficacy and Safety of KDS2010 in Overweight or Obese Patients","A Randomized, Double-blind, Placebo-controlled, Dose Finding, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of KDS2010 in Overweight or Obese Patients","Inclusion Criteria:\n\n* Adult males and females aged 18 years or older (or the legal age of adulthood in the respective country) as of the date of written consent\n* Subjects with BMI ≥30 kg\u002Fm² or BMI ≥27 kg\u002Fm² with at least one weight-related comorbidity (hypertension, dyslipidemia, cardiovascular disease, obstructive sleep apnea) at screening and baseline\n\n  * Hypertension: under treatment or have Systolic Blood Pressure (SBP) ≥130 mmHg or Diastolic Blood Pressure (DBP) ≥80 mmHg\n  * Dyslipidemia: under treatment or LDL \\> 160 mg\u002FdL or TG \\> 200 mg\u002FdL or HDL \\\u003C 40 mg\u002FdL\n  * Cardiovascular diseases (e.g., ischemic cardiovascular disease, NYHA Class I to III heart failure, Peripheral vascular disease (PVD), Abdominal aortic aneurysm (AAA), etc.)\n  * Obstructive sleep apnoea\n* Subjects who have documented a 500 kcal reduction\u002Fday in calorie intake and ≥150 minutes of physical activity\u002Fweek for ≥50% of the time during the run-in period\n* Subjects who have voluntarily provided written consent to participate after being informed about this clinical trial\n\nExclusion Criteria:\n\n* Subjects with a weight change of 5% or more within 12 weeks before screening\n* Subjects with less than 80% or more than 120% compliance during the Run-in period\n* Subjects with obesity due to secondary causes (neurological disorders, endocrine disorders, genetic disorders, congenital disorders, etc.)\n* Subjects with following medical history,\n\n  * Type 1 or Type 2 diabetes\n  * History of bariatric\u002Fmetabolic surgery (e.g., adjustable gastric banding, intragastric balloon insertion, sleeve gastrectomy, Roux-en-Y gastric bypass, biliopancreatic diversion, duodenal switch) or planning to undergo such surgery during the study period\n  * Heart failure classified as NYHA class IV\n  * Subjects with a medical history of malignant tumors within 5 years prior to screening (however, subjects with successfully treated basal cell carcinoma, squamous cell carcinoma of the skin, thyroid cancer, or other carcinoma in situ, with no recurrence for more than 3 years, may be enrolled at the investigator's discretion)\n  * Subjects with a medical history of hypersensitivity to MAO inhibitors\n  * Subjects with a medical history of cerebrovascular disease (e.g., transient ischemic attack, stroke) within 12 weeks prior to baseline, or those hospitalized for unstable angina or congestive heart failure\n  * Subjects with a history of depressive disorders or psychiatric disorders (e.g., schizophrenia, bipolar disorder, anxiety disorder) within 2 years prior to screening\n* Subjects with a history of the following drug administration,\n\n  \\-- Anti-obesity agents or weight-loss medications (including dietary supplements and herbal medicine) within 12 weeks before screening\n  * Corticosteroids administered for 2 consecutive weeks or more within 12 weeks before screening (however, topical preparations, including inhalants, are allowed)\n  * Treatment for hyperthyroidism or hypothyroidism at the time of screening (subjects on a stable dose and regimen for at least 12 weeks may be enrolled at the investigator's discretion)\n  * MAO inhibitors within 2 weeks before baseline\n  * Opioid medications (e.g., pethidine, Tramadol, Tapentadol) within 2 weeks before baseline\n  * Serotonergic drugs within 2 weeks before baseline,\n\n    * Selective Serotonin Reuptake Inhibitors (SSRI), ② Serotonin-Norepinephrine Reuptake Inhibitors (SNRI),\n\n      * Tricyclic or Tetracyclic antidepressant, ④ Triazolopyridine antidepressant, ⑤ Selective serotonin (5-HT1) agonists (Sumatriptan, etc.), (However, amitriptyline ≤50 mg\u002Fday, trazodone ≤100 mg\u002Fday, citalopram ≤20 mg\u002Fday, sertraline ≤100 mg\u002Fday, paroxetine ≤30 mg\u002Fday are allowed; long half-life serotonergic drugs (e.g., fluoxetine) require at least a 5-week wash out period before enrollment),\n  * Lithium, Bupropion, Lamotrigine, Ritonavir, Cyclobenzaprine, or St. John's wort within 2 weeks before baseline\n  * Hypertension crisis-inducing drugs (e.g., oxymetazoline, phentermine, phenylephrine) within 2 weeks before baseline\n  * Sympathomimetic agents (e.g., ephedrine, methylphenidate, amphetamine, methamphetamine, lisdexamfetamine) at the time of screening\n  * Dextromethorphan at the time of screening\n* Subjects who meet following criteria based on the tests conducted at Screening\n\n  * Glycated hemoglobin (HbA1c) ≥6.5%\n  * Hepatic impairment (Child-pugh class C)\n  * AST or ALT \\> 2.5 X ULN\n  * Total bilirubin \\>1.5 X ULN (however, \\>3.0 mg\u002FdL is acceptable in cases of Gilbert syndrome)\n  * Severe renal impairment (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m² calculated using the MDRD formula\\*),\n\n    \\* eGFR = 175 X (Serum creatinine)-1.154 X (Age)-0.203 X (0.742 (for females)) X (1.212 (for African Americans))\n  * TSH \\>6.0 mIU\u002FL or \\\u003C0.4 mIU\u002FL,\n* Subjects with a lifetime history of suicide attempts\n* Subjects with a PHQ-9 score of 10 or higher at screening\n* Subjects who answer affirmatively to item 4 or 5 on the C-SSRS at screening\n* Pregnant or breastfeeding women\n* Females of childbearing potential and males who do not agree to use adequate contraception# until at least 2 weeks after the last dose of the IP or who plan to conceive during the study period,\n\n  * Adequate contraception is defined as double contraception using both barrier methods (male condom or female condom) and one of the contraceptive methods ①-③.\n\n    * Hormonal contraceptive (oral, injectable, implantable, etc.), ② Implantation of Intrauterine device (IUD) or intrauterine system (IUS), ③ Sterilization procedures or surgeries (bilateral tubal ligation, hysterectomy, vasectomy), ④ Complete abstinence: absolute abstinence is accepted if, in the investigator's judgment, the subject's age, occupation, lifestyle, or sexual orientation ensure compliance with contraception. However, periodic abstinence (calendar method, ovulation method, symptothermal method, etc.) withdrawal, and coitus interruptus are not considered adequate contraceptive methods.,\n* Subjects who have participated in another clinical trial and received an investigational drug or device within 4 weeks prior to screening\n* Other reasons (such as a medical history of alcohol or substance abuse) that the investigator deems the subject unsuitable for participation in this clinical trial",{"count":534,"type":23},75,[205],"This is a randomized, double-blind, placebo-controlled, dose-finding, Phase 2a study designed to evaluate the safety and efficacy of KDS2010 in overweight or obese patients. Based on preliminary efficacy observed in the Phase 1 study, this clinical trial is being conducted in Korea.\n\nAfter a minimum 2-week run-in period, subjects who meet the inclusion and exclusion criteria will be randomized to the treatment group or placebo group at a 2:1 ratio in each stage.\n\nSubjects will receive the investigational product for 12 weeks following randomization. The study will be conducted in three stages.\n\nApproximately 75 subjects will be enrolled, with 6 subjects in the KDS2010 120 mg group and 3 subjects in the placebo group in Stage 1, 22 subjects in the KDS2010 180 mg group and 11 subjects in the placebo group in Stage 2, and 22 subjects in the KDS2010 240 mg group and 11 subjects in the placebo group in Stage 3.\n\nThe primary objectives are to assess the efficacy and safety of KDS2010 in overweight or obese patients. Exploratory objectives include evaluating the proportion of subjects achieving a weight reduction of more than 25% from baseline at Week 12 and assessing changes in MAO-B specific activity and adiponectin levels.\n\nBased on nonclinical and Phase 1 clinical data, KDS2010 will be administered orally once daily at doses of 120 mg, 180 mg, and 240 mg throughout the study.",[35,33,538],"Obese Patients",[538,35,540,33,541],"KDS2010","MAO-B inhibitor",{"date":210,"type":45},{"date":544,"type":45},"2025-07-29",{"date":546,"type":23},"2027-06-30",{"name":548,"class":105},"NeuroBiogen Co., Ltd"]