A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)

Conditions

• Obesity

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• survodutide — COMBINATION_PRODUCT
  once weekly subcutaneous injection, pre-filled syringe
• Placebo — COMBINATION_PRODUCT
  once weekly subcutaneous injection, pre-filled syringe

Study Details

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.

Key Dates

Start date

Nov 20, 2023

Status verified

Jun 2026

Primary completion

May 8, 2026

Completion

Jun 22, 2026

Study Design

Enrollment

5,531 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: survodutide 3.6 mg
• Experimental: survodutide 6.0 mg
• Placebo Comparator: Placebo

Primary Outcome Measure

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 ]

Locations (153)

Related coverage on Hipa.ai

• Survodutide Phase 3 CVOT Study for Overweight/Obesity Completes Primary Endpoint
  Survodutide · May 8, 2026 · ClinicalTrials.gov
• Survodutide SYNCHRONIZE™-CVOT Phase 3 Trial Reaches Primary Completion
  Survodutide · May 1, 2026 · ClinicalTrials.gov

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