COMBINATION_PRODUCT
survodutide
once weekly subcutaneous injection, pre-filled syringe
A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)
Status
Completed
Phase
Phase 3
Enrollment
5,531
Locations
540
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
COMBINATION_PRODUCT
Placebo
once weekly subcutaneous injection, pre-filled syringe
Timeline
From registration to results.
First posted
Oct 11, 2023
Study start
Nov 20, 2023
Primary completion
Jun 1, 2026
Study completion
Jun 30, 2026
Results posted
Not reported
Registry updated
Jul 23, 2026
Outcomes
What the study measures.
Primary outcomes
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)
Time frame · 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
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)
Time frame · up to Week 114
Absolute change in systolic blood pressure (SBP) (mmHg) from baseline to Week 72
Time frame · Baseline and at Week 72
Absolute change in waist circumference (cm) from baseline to Week 72
Time frame · Baseline and at Week 72
Absolute change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) from baseline to Week 72 in trial participants with HF at baseline
Time frame · 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.
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)
Time frame · up to Week 114
Percentage change in body weight from baseline to Week 72
Time frame · Baseline and at Week 72
Absolute change in diastolic blood pressure (DBP) (mmHg) from baseline to Week 72
Time frame · Baseline and at Week 72
Absolute change in aspartate aminotransferase (AST) (U/L) from baseline to Week 72
Time frame · Baseline and at Week 72
Absolute change in alanine aminotransferase (ALT) (U/L) from baseline to Week 72
Time frame · Baseline and at Week 72
Absolute change in glycosylated haemoglobin A1c (HbA1c) (mmol/mol) from baseline to Week 72 in trial participants with type 2 diabetes mellitus (T2DM)
Time frame · Baseline and at Week 72
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- 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.
Study locations
540 registered sites.
Argentina · Australia · Austria · Belgium · Brazil · Bulgaria · Canada · China · Czechia · Denmark · Finland · Germany · Greece · Hong Kong · Hungary · India · Ireland · Italy · Japan · Kazakhstan · Mexico · Netherlands · New Zealand · Norway · Poland · Portugal · Puerto Rico · Saudi Arabia · Slovakia · South Korea · Spain · Taiwan · Turkey (Türkiye) · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Cardiology P.C.
Birmingham, Alabama, United States
AMR Daphne
Daphne, Alabama, United States
AMR Mobile
Mobile, Alabama, United States
Mobile Heart Specialists, PC
Mobile, Alabama, United States
The Institute for Liver Health II DBA Arizona Clinical Trials
Chandler, Arizona, United States
Clinical Research Institute of Arizona, LLC
Sun City West, Arizona, United States
AMR Phoenix
Tempe, Arizona, United States
Arizona Liver Health-Tucson-67516
Tucson, Arizona, United States
Yuma Clinical Trials
Yuma, Arizona, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States
Velocity Clinical Research-Huntington Park
Huntington Park, California, United States
Velocity Clinical Research, San Diego
La Mesa, California, United States
Velocity Clinical Research - Los Angeles
Los Angeles, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
NorCal Endocrinology and Internal Medicine
San Ramon, California, United States
Velocity Clinical Research, Santa Ana
Santa Ana, California, United States
NorthBay Clinical Research, LLC
Santa Rosa, California, United States
Velocity Clinical Research-Van Nuys-70286
Van Nuys, California, United States
Peak Gastroenterology Associates-Colorado Springs-62256
Colorado Springs, Colorado, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
CMR of Greater New Haven, LLC
Hamden, Connecticut, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
Proactive Clinical Research
Boca Raton, Florida, United States
Related trials
More studies on Survodutide.
NCT IDStudyPhase / statusEnrollmentUpdated
A Study in People With Overweight or Obesity to Compare How 2 Different Formulations of Survodutide Are Taken up by the Body
Boehringer Ingelheim · Healthy · Obesity
Phase 1
Recruiting
80
2026-07
A Study in People With Obesity to Test the Effects of BI 456906 Compared With Semaglutide on Glucagon Receptor Activity in the Liver
Boehringer Ingelheim · Obesity
Phase 1
Active, not recruiting
29
2026-07
LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
Boehringer Ingelheim · Metabolic Dysfunction Associated Steatohepatitis (MASH) · Liver Fibrosis
Phase 3
Recruiting
1,800
2026-07
LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis
Boehringer Ingelheim · Metabolic Dysfunction Associated Steatohepatitis
Phase 3
Recruiting
1,590
2026-07
A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight
Boehringer Ingelheim · Obesity · Diabetes Mellitus, Type 2
Phase 3
Completed
755
2026-06
A Study in Healthy People or Otherwise Healthy With Overweight or Obesity to Compare 2 Formulations of Survodutide Given in Different Ways, Either as a Pre-filled Syringe or a Pen-like Injector
Boehringer Ingelheim · Healthy · Obesity
Phase 1
Completed
56
2026-06
A Study to Test Whether Survodutide Improves How the Body Uses Energy and Breaks Down Fat in People With Obesity
Boehringer Ingelheim · Obesity
Phase 1
Active, not recruiting
64
2026-05
A Study to Test Whether Survodutide Helps Japanese People Living With Obesity Disease
Boehringer Ingelheim · Obesity
Phase 3
Completed
274
2026-04
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.