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

Completed · Phase 3 · Has a placebo group

Conditions studied: Obesity

In brief

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 facts

Study ID

NCT06077864

Run by

Boehringer Ingelheim

People needed

5531

Starts

2023-11-20

Expected to finish

2026-06-30

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Takagi Hospital — Fukuoka, Okawa, Japan
• Seino Internal Medicine Clinic — Fukushima, Koriyama, Japan
• Iryouhouijneiwakai Minamiakatsuka Clinic — Ibaraki, Mito, Japan
• Matsuba Clinic — Kanagawa, Kawasaki, Japan
• Sagamihara Kyodo Hospital — Kanagawa, Sagamihara, Japan
• Saiseikai Yokohamashi Nanbu Hospital — Kanagawa, Yokohama, Japan
• Takeshita Hospital — Kochi, Kochi, Japan
• 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
• Universität des Saarlandes — Homburg, Germany

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.