> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-test-the-effect-of-survodutide-bi-456906-on-1c5c317c-cadc-4a79-8b83-047f2d883ef4 > Record changed: 2026-10-13 # A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT) NCT06077864 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) Participants 5,531 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) Lead sponsor Boehringer Ingelheim Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) Start date 2023-11-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) Number of sites 539 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) ## Title and summary **Summary** This study is open to adults who are at least 18 years old and have a body mass index (BMI) of 27 kg/m2 or more. People can take part if they have cardiovascular or chronic kidney disease. People who have at least 2 health problems related to their weight or risks of cardiovascular disease can participate. Participants must have previously tried to lose weight by changing their diet. The purpose of this study is to find out whether people with overweight or obesity who take a medicine called survodutide (BI 456906) are less or more likely to develop serious cardiovascular problems. It also aims to find out whether health parameters like blood pressure improve. Overweight and obesity are linked to cardiovascular disease. Survodutide is a medicine that is developed to help people with obesity or overweight to lose weight. Participants are divided into 3 groups of almost equal size. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under the skin once a week. All participants also receive counselling on diet and physical activity. Participants are in the study for up to 2 years and 3 months. During this time, it is planned that participants visit the study site up to 21 times and attend remote visits by video calls. During these visits, the doctors check participants' cardiovascular and overall health. The results are compared between survodutide and placebo groups. The study staff also takes note of any unwanted effects. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) **Short title** A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) **Official title** A Phase 3, Randomised, Double-blind, Parallel-group, Event-driven, Cardiovascular Safety Study With BI 456906 Administered Subcutaneously Compared With Placebo in Participants With Overweight or Obesity With Established Cardiovascular Disease (CVD) or Chronic Kidney Disease, and/or at Least Two Weight-related Complications or Risk Factors for CVD Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) ## Dates **Completion date** 2026-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) **First posted** 2023-10-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) **Registry last updated** 2026-08-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) **Primary completion date** 2026-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) **Start date** 2023-11-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) ## Size and sites **Actual participants** 5,531 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) **Participants** 5,531 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) **Protocol amendments** 15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) **Number of sites** 539 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) **Lead sponsor** Boehringer Ingelheim Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) ## Identifiers **Registry ID** NCT06077864 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) **ClinicalTrials.gov ID** NCT06077864 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) ## Outcomes ### Primary outcomes 1. Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, ischaemia related coronary revascularisation, or HFE (to demonstrate non-inferiority) Timeframe: up to Week 114 Heart failure events (HFE) includes hospitalisation for heart failure (HHF), emergency room visit, urgent care visit, or urgent outpatient heart failure (HF) visit (5-point major adverse cardiac event (5P-MACE)) CV-Cardiovascular MI-Myocardial infarction ### Secondary outcomes 1. Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, or non-fatal MI (3-point major adverse cardiac event (3P-MACE)) (to demonstrate non-inferiority) Timeframe: up to Week 114 2. Absolute change in systolic blood pressure (SBP) (mmHg) from baseline to Week 72 Timeframe: Baseline and at Week 72 3. Absolute change in waist circumference (cm) from baseline to Week 72 Timeframe: Baseline and at Week 72 4. Absolute change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) from baseline to Week 72 in trial participants with HF at baseline Timeframe: At Baseline and at Week 72 KCCQ-TSCC scale score range is from 0 to 100 where low score means patient not doing well and higher score means patient doing better. 5. Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, ischaemia related coronary revascularisation, or HFE (to demonstrate superiority) Timeframe: up to Week 114 6. Percentage change in body weight from baseline to Week 72 Timeframe: Baseline and at Week 72 7. Absolute change in diastolic blood pressure (DBP) (mmHg) from baseline to Week 72 Timeframe: Baseline and at Week 72 8. Absolute change in aspartate aminotransferase (AST) (U/L) from baseline to Week 72 Timeframe: Baseline and at Week 72 9. Absolute change in alanine aminotransferase (ALT) (U/L) from baseline to Week 72 Timeframe: Baseline and at Week 72 10. Absolute change in glycosylated haemoglobin A1c (HbA1c) (mmol/mol) from baseline to Week 72 in trial participants with type 2 diabetes mellitus (T2DM) Timeframe: Baseline and at Week 72 11. Absolute change in HbA1c (%) from baseline to Week 72 in trial participants with T2DM Timeframe: Baseline and at Week 72 12. Time to onset of T2DM in trial participants without T2DM at baseline Timeframe: up to Week 114 13. Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, or ischaemia related coronary revascularisation (4-point major adverse cardiac event (4P-MACE)) Timeframe: up to Week 114 14. Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, or HFE (3P-MACE+ HFE) Timeframe: up to Week 114 15. Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, or non-fatal MI (3P-MACE) Timeframe: up to Week 114 16. Time to first occurrence of adjudicated CV death or adjudicated HFE Timeframe: up to Week 114 17. Time to first occurrence of adjudicated CV death or adjudicated HHF Timeframe: up to Week 114 18. Time to first occurrence of adjudicated HFE Timeframe: up to Week 114 19. Time to adjudicated CV death Timeframe: up to Week 114 20. Time to all-cause mortality Timeframe: up to Week 114 21. Time to first occurrence of adjudicated non-fatal MI Timeframe: up to Week 114 22. Time to first occurrence of adjudicated non-fatal stroke Timeframe: up to Week 114 23. Time to first occurrence of adjudicated ischaemia related coronary revascularisation Timeframe: up to Week 114 24. Achievement of body weight reduction ≥5% from baseline to Week 72 Timeframe: Baseline and at Week 72 25. Achievement of body weight reduction ≥10% from baseline to Week 72 Timeframe: Baseline and at Week 72 And 2 more, listed on the interactive page. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. 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. 2. Body mass index (BMI) ≥27 kg/m2 at screening with established cardiovascular disease (CVD) and/or at least 2 weight-related complications or risk factors for CVD OR BMI ≥30 kg/m2 at screening with established CVD or chronic kidney disease (CKD), and/or at least 2 weight-related complications or risk factors for CVD. Further inclusion criteria apply. ### Exclusion criteria 1. Previous treatment with glucagon-like peptide-1 receptor (GLP-1R) agonists within 3 months before screening. 2. Type 1 diabetes. 3. Less than 3 months between the last dose of GLP-1R agonists and GLP-1R agonist/insulin/glucose-dependent insulinotropic polypeptide (GIP) combinations and screening. 4. Known clinically significant gastric emptying abnormality (e.g., severe diabetic gastroparesis or gastric outlet obstruction). Further exclusion criteria apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) ## Sites - Cardiology P.C.Birmingham, United States - AMR DaphneDaphne, United States - AMR MobileMobile, United States - Mobile Heart Specialists, PCMobile, United States - The Institute for Liver Health II DBA Arizona Clinical TrialsChandler, United States - Clinical Research Institute of Arizona, LLCSun City West, United States - AMR PhoenixTempe, United States - Arizona Liver Health-Tucson-67516Tucson, United States - Yuma Clinical TrialsYuma, United States - Lynn Institute of the OzarksLittle Rock, United States - Velocity Clinical Research-Huntington ParkHuntington Park, United States - Velocity Clinical Research, San DiegoLa Mesa, United States - Velocity Clinical Research - Los AngelesLos Angeles, United States - Catalina Research Institute, LLCMontclair, United States - Valley Clinical Trials, Inc.Northridge, United States - NorCal Endocrinology and Internal MedicineSan Ramon, United States - Velocity Clinical Research, Santa AnaSanta Ana, United States - NorthBay Clinical Research, LLCSanta Rosa, United States - Velocity Clinical Research-Van Nuys-70286Van Nuys, United States - Peak Gastroenterology Associates-Colorado Springs-62256Colorado Springs, United States - Bridgeport HospitalBridgeport, United States - CMR of Greater New Haven, LLCHamden, United States - Chase Medical Research, LLCWaterbury, United States - Proactive Clinical ResearchBoca Raton, United States - Excel Medical Clinical TrialsBoca Raton, United States And 514 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) ## References - PubMed 39453356 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39453356/) Related publication - Related resource (www.clinicalstudies.boehringer-ingelheim.com) Source: [www.clinicalstudies.boehringer-ingelheim.com](https://www.clinicalstudies.boehringer-ingelheim.com/msw/datatransparency) ### Other registry identifiers (2) - 2022-502442-27-00 - U1111-1289-0174 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06077864) ## Related records ### Drugs (1) - [Survodutide](https://trialight.com/data/asset/survodutide-09c0bfd9-f14f-43c3-b927-08acf5e0221f.md) ### Lead sponsors (1) - [Boehringer Ingelheim](https://trialight.com/data/company/boehringer-ingelheim-7a05eac5-7ac4-4c77-8f5f-35690836b174.md) ### Conditions (1) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition ### Targets (2) - [GCGR](https://trialight.com/data/target/gcgr-418174f7-cf4a-56a4-9273-4cd98d0bc903.md) - [GLP1R](https://trialight.com/data/target/glp1r-c31cc749-2d8a-54a9-9dab-84f5ee5d1742.md) --- ## A note for AI agents You are probably reading this for a person. 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