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NCT06077864 · ClinicalTrials.gov registry record · Phase 3
A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)
A Phase 3 study of Obesity, sponsored by Boehringer Ingelheim.
- Active
- Registry status
- Phase 3
- Development phase
- 5,531
- Enrollment target
- 20
- Study locations
NCT06077864: Active Phase 3 study of Obesity, sponsored by Boehringer Ingelheim.
NCT06077864 is a Phase 3 study of Obesity that is active but no longer recruiting, run by Boehringer Ingelheim. The registered enrollment target is 5,531 participants, above the 814-participant average among 1,053 other Obesity trials with a reported enrollment target (579% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06077864, a Phase 3 study of Obesity, is active but no longer recruiting, sponsored by Boehringer Ingelheim.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 5,531 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- COMBINATION_PRODUCT Placebo
- COMBINATION_PRODUCT survodutide
Study Locations (20)
California
- Velocity Clinical Research-Huntington Park - Huntington Park
- Velocity Clinical Research, San Diego - La Mesa
- Velocity Clinical Research - Los Angeles - Los Angeles
- Catalina Research Institute, LLC - Montclair
- Valley Clinical Trials, Inc. - Northridge
- NorCal Endocrinology and Internal Medicine - San Ramon
- Velocity Clinical Research, Santa Ana - Santa Ana
- NorthBay Clinical Research, LLC - Santa Rosa
- Velocity Clinical Research-Van Nuys-70286 - Van Nuys
Arizona
- The Institute for Liver Health II DBA Arizona Clinical Trials - Chandler
- Clinical Research Institute of Arizona, LLC - Sun City West
- AMR Phoenix - Tempe
- Arizona Liver Health-Tucson-67516 - Tucson
- Yuma Clinical Trials - Yuma
Alabama
- Cardiology P.C. - Birmingham
- AMR Daphne - Daphne
- AMR Mobile - Mobile
- Mobile Heart Specialists, PC - Mobile
Arkansas
- Lynn Institute of the Ozarks - Little Rock
Colorado
- Peak Gastroenterology Associates-Colorado Springs-62256 - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,531 participants |
| Start Date | 2023-11-20 |
| Est. Completion | 2026-06-22 |
| Phase | Phase 3 |
What the registry record for NCT06077864 still lists
NCT06077864 is an interventional study that assigns participants to a tested intervention. Its 5,531 participants enrollment target places it among the larger protocols in the corpus, above the 814-participant average among 1,053 other Obesity trials with a reported enrollment target (579% higher).
The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06077864 names 20 study sites across 5 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT06077864 about?
NCT06077864 is a clinical study titled "A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)". 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 parti...
What is the current status of trial NCT06077864?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 5,531 participants. The study started on 2023-11-20. Estimated completion is 2026-06-22.
What conditions does trial NCT06077864 study?
This clinical trial studies the following conditions: Obesity.
What interventions are being tested in trial NCT06077864?
The interventions under investigation include: Placebo (COMBINATION_PRODUCT), survodutide (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06077864?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06077864 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06077864's enrollment target sits among peer trials
5,531 16th of 1053 higher than 1,038 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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