A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)
- 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.
- Short title
- A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2026-06-30
- First posted
- 2023-10-11
- Registry last updated
- 2026-08-11
- Primary completion date
- 2026-06-01
- Start date
- 2023-11-20
- Actual participants
- 5,531
- Participants
- 5,531
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Boehringer Ingelheim
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06077864
- ClinicalTrials.gov ID
- NCT06077864
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
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
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
Absolute change in systolic blood pressure (SBP) (mmHg) from baseline to Week 72
Timeframe: Baseline and at Week 72
Absolute change in waist circumference (cm) from baseline to Week 72
Timeframe: 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
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.
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
Percentage change in body weight from baseline to Week 72
Timeframe: Baseline and at Week 72
Absolute change in diastolic blood pressure (DBP) (mmHg) from baseline to Week 72
Timeframe: Baseline and at Week 72
Absolute change in aspartate aminotransferase (AST) (U/L) from baseline to Week 72
Timeframe: Baseline and at Week 72
Absolute change in alanine aminotransferase (ALT) (U/L) from baseline to Week 72
Timeframe: 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)
Timeframe: Baseline and at Week 72
Absolute change in HbA1c (%) from baseline to Week 72 in trial participants with T2DM
Timeframe: Baseline and at Week 72
Time to onset of T2DM in trial participants without T2DM at baseline
Timeframe: up to Week 114
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
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
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
Time to first occurrence of adjudicated CV death or adjudicated HFE
Timeframe: up to Week 114
Time to first occurrence of adjudicated CV death or adjudicated HHF
Timeframe: up to Week 114
Time to first occurrence of adjudicated HFE
Timeframe: up to Week 114
Time to adjudicated CV death
Timeframe: up to Week 114
Time to all-cause mortality
Timeframe: up to Week 114
Time to first occurrence of adjudicated non-fatal MI
Timeframe: up to Week 114
Time to first occurrence of adjudicated non-fatal stroke
Timeframe: up to Week 114
Time to first occurrence of adjudicated ischaemia related coronary revascularisation
Timeframe: up to Week 114
Achievement of body weight reduction ≥5% from baseline to Week 72
Timeframe: Baseline and at Week 72
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.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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.
- 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.
- Previous treatment with glucagon-like peptide-1 receptor (GLP-1R) agonists within 3 months before screening.
- Type 1 diabetes.
- 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.
- Known clinically significant gastric emptying abnormality (e.g., severe diabetic gastroparesis or gastric outlet obstruction).
Further exclusion criteria apply.
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- PubMed 39453356Related publication
- Related resource (www.clinicalstudies.boehringer-ingelheim.com)
- 2022-502442-27-00
- U1111-1289-0174
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Obesity disorder Primary condition