{ "data": { "asOf": "2026-10-30T22:24:26.528Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT07855900", "title": "SYNCHRONIZE®-START- A Study to Test Whether Survodutide Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight", "scientificTitle": "A Phase IIIb, Open-label, Pragmatic Study Evaluating Initiation Strategies for Survodutide, Including de Novo Use and Switching From Semaglutide or Tirzepatide, in Participants With Overweight/Obesity Without Diabetes Mellitus-SYNCHRONIZE® - START", "status": "not_yet_recruiting", "studyType": "interventional", "phase": [ "PHASE3" ], "conditions": [ "Obesity" ], "interventions": [ { "name": "Survodutide", "type": "COMBINATION_PRODUCT", "description": "Survodutide" } ], "sponsor": { "name": "Boehringer Ingelheim", "type": "INDUSTRY" }, "locations": [ { "city": "Riverview", "country": "United States", "facility": "Covenant Metabolic Specialist, LLC - Riverview" }, { "city": "Macon", "country": "United States", "facility": "The Jones Center Clinical Research, LLC" } ], "outcomes": { "other": [], "primary": [ "Percent change in body weight from baseline to Week 52" ], "secondary": [ "Absolute change from baseline in PROMIS Physical Function (PF-SF10a) score (units on a scale) to Week 52", "Absolute change from baseline in PROMIS Ability to Participate in Social Roles and Activities SF8a total score (units on a scale) to Week 52", "Absolute change from baseline in IWQOL-Lite-CT total scale score (units on a scale) to Week 52", "Absolute change from baseline in IWQOL-Lite-CT physical scale score (units on a scale) to Week 52", "Absolute change from baseline in IWQOL-Lite-CT physical function scale score (units on a scale) to Week 52", "Absolute change from baseline in IWQOL-Lite-CT psychosocial scale score (units on a scale) to Week 52", "Absolute change from baseline to Week 52 in Body Mass Index (BMI) [kg/m2]", "Absolute change from baseline to Week 52 in Waist circumference [cm]", "Absolute change from baseline to Week 52 in Systolic Blood Pressure (SBP) [mmHg]", "Absolute change from baseline to Week 52 in Glycosylated Haemoglobin A1c (HbA1c) [%]", "Relative change from baseline to Week 52 in High Sensitivity C-Reactive Protein (hs-CRP) [mg/L]", "Relative change from baseline to Week 52 in Non-High-Density Lipoprotein (HDL) cholesterol [mg/dL]", "Relative change from baseline to Week 52 in Triglycerides [mg/dL]" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion criteria:\n\n1. Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is \\>18 years\n2. History of at least one self-reported unsuccessful dietary effort to lose body weight\n3. Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. Persons must be capable of giving informed consent independently\n4. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control as provided in the protocol Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Body weight change (self-reported) \\>2.5% during run-in period before screening\n2. Have obesity induced by other endocrinologic disorders (i.e. Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (i.e. melanocortin 4 receptor deficiency, leptin deficiency, or Prader Willi Syndrome)\n3. Hemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening\n4. History of Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) or treatment with glucose-lowering agent (for the purpose of treating diabetes) started within 3 months before the screening visit up to and including the baseline visit Further exclusion criteria apply.", "minimumAge": "18 Years", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 350 }, "startDate": "2026-11-07", "completionDate": "2029-11-06", "lastUpdated": "2026-10-27T00:00:00.000Z", "firstPosted": "2026-10-02T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT07855900" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT07855900", "declaredBy": "clinicaltrials_gov" }, { "idType": "euct", "idValue": "2026-527093-36-00", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07855900", "sourceUrl": "https://clinicaltrials.gov/study/NCT07855900", "sourceStatus": "NOT_YET_RECRUITING", "retrievedAt": "2026-10-28T04:32:38.871Z", "payloadSha256": "f2b9b3da8a926366ffaa24450efa4f9663ad861c2be4b81e4aa84d2ed6e4ad94", "piiRedacted": true } ], "citation": { "canonicalId": "NCT07855900", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07855900", "verifyAt": "https://clinicaltrials.gov/study/NCT07855900", "retrievedAt": "2026-10-28T04:32:38.871Z", "payloadSha256": "f2b9b3da8a926366ffaa24450efa4f9663ad861c2be4b81e4aa84d2ed6e4ad94", "text": "ClinicalTrials.gov, record NCT07855900 (https://clinicaltrials.gov/study/NCT07855900), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT07855900, registered in ClinicalTrials.gov, retrieved 2026-10-28. 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