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A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)
Sponsor: Boehringer Ingelheim
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
5530
Start Date
2023-11-20
Completion Date
2026-06-30
Last Updated
2026-10-29
Healthy Volunteers
No
Conditions
Interventions
survodutide
once weekly subcutaneous injection, pre-filled syringe
Placebo
once weekly subcutaneous injection, pre-filled syringe
Locations (542)
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
Excel Medical Clinical Trials
Boca Raton, Florida, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
Nature Coast Clinical Research-Crystal River-62355
Crystal River, Florida, United States
Beautiful Minds Clinical Research Center
Cutler Bay, Florida, United States
AMR Fort Myers
Fort Myers, Florida, United States
Covenant Metabolic Specialists, LLC - Fort Myers
Fort Myers, Florida, United States
Velocity Clinical Research-Hallandale Beach-67888
Hallandale, Florida, United States
Westside Center for Clinical Research
Jacksonville, Florida, United States
Clinical Site Partners LLC
Leesburg, Florida, United States
Flourish Research - Miami
Miami, Florida, United States
Verus Clinical Research Corporation
Miami, Florida, United States
Center for Diabetes, Obesity and Metabolism
Pembroke Pines, Florida, United States
Synexus-Pinellas Park-69294
Pinellas Park, Florida, United States
East Coast Institute for Research, LLC-Saint Augustine-63032
Saint Augustine, Florida, United States
Lenus Research & Medical Group
Sweetwater, Florida, United States
Santos Research Center, Corp.
Tampa, Florida, United States
Covenant Metabolic Specialists, LLC - Sarasota
University Park, Florida, United States
Javara-Albany-67356
Albany, Georgia, United States
Centricity Research Columbus Georgia Multispecialty
Columbus, Georgia, United States
Javara-Fayetteville-67354
Fayetteville, Georgia, United States
NSC Research Inc
Johns Creek, Georgia, United States
The Jones Center Clinical Research, LLC
Macon, Georgia, United States
Urban Family Practice Associates, PC
Marietta, Georgia, United States
Javara-Savannah-67450
Savannah, Georgia, United States
Endeavor Health Clinical Operations - Northwest Community Healthcare
Arlington Heights, Illinois, United States
Cedar Crosse Research Center
Chicago, Illinois, United States
Research by Design, LLC
Chicago, Illinois, United States
Medisphere Medical Research Center
Evansville, Indiana, United States
McFarland Clinic PC
Ames, Iowa, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
AMR El Dorado
El Dorado, Kansas, United States
AMR Newton
Newton, Kansas, United States
AMR Clinical Wichita
Wichita, Kansas, United States
Research Integrity, LLC
Owensboro, Kentucky, United States
Grace Research, LLC-Bossier City-51040
Bossier City, Louisiana, United States
Heart Clinic of Hammond
Hammond, Louisiana, United States
Tandem Clinical Research
Marrero, Louisiana, United States
AMR New Orleans
New Orleans, Louisiana, United States
Grace Research, LLC-Shreveport-64616
Shreveport, Louisiana, United States
Javara Inc.-Annapolis-68997
Annapolis, Maryland, United States
Ascension Saint Agnes Heart Care
Baltimore, Maryland, United States
MD Medical Research
Oxon Hill, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Domino's Farms
Ann Arbor, Michigan, United States
Elite Research Center, LLC
Flint, Michigan, United States
Healthy Heart Cardiology
Grand Rapids, Michigan, United States
Mayo Clinic, Rochester
Rochester, Minnesota, United States
The National Diabetes & Obesity Research Institute
Diamondhead, Mississippi, United States
Prime Health and Wellness
Fayette, Mississippi, United States
Velocity Clinical Research-Gulfport-68930
Gulfport, Mississippi, United States
Johnson County ClinTrials
Kansas City, Missouri, United States
AMR Kansas City
Kansas City, Missouri, United States
Clinvest Research LLC
Springfield, Missouri, United States
Sundance Clinical Research, LLC
St Louis, Missouri, United States
Mercury Street Medical
Butte, Montana, United States
Skyline Medical Center
Elkhorn, Nebraska, United States
Methodist Physicians Clinic
Fremont, Nebraska, United States
AMR Las Vegas
Las Vegas, Nevada, United States
Advanced Heart Care, LLC
Bridgewater, New Jersey, United States
NJ Heart LLC
Linden, New Jersey, United States
IMA Clinical Research-Warren-69742
Warren Township, New Jersey, United States
IMA Clinical Research Albuquerque
Albuquerque, New Mexico, United States
Velocity Clinical Research - Binghamton
Binghamton, New York, United States
Synexus Clinical Research US, Inc.
New York, New York, United States
Saratoga Clinical Research, LLC
Saratoga Springs, New York, United States
Accellacare of Cary
Cary, North Carolina, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Javara-Charlotte-67884
Charlotte, North Carolina, United States
Accellacare-Mooresville-69123
Mooresville, North Carolina, United States
Centricity Research (New Bern)
New Bern, North Carolina, United States
Wake Forest University Health Sciences-Winston-Salem-69719
Winston-Salem, North Carolina, United States
Velocity Clinical Research-Cincinnati-69044
Cincinnati, Ohio, United States
Synexus Clinical Research-Columbus-69427
Columbus, Ohio, United States
Centricity Research-Columbus-68879
Columbus, Ohio, United States
Aventiv Research Inc.-Dublin-62009
Dublin, Ohio, United States