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ClinicalTrials.gov record
Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT06077864

Public ClinicalTrials.gov record NCT06077864. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 11:14 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06077864
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Boehringer Ingelheim
Industry
Enrollment
5,531 participants

Conditions and interventions

Conditions

Interventions

Combination Product

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 20, 2023 (Actual)
Primary completion
Jun 1, 2026 (Actual)
Completion
Jun 30, 2026 (Actual)
Last update posted
Sep 30, 2026

2023 – 2026

United States locations

U.S. sites
153
U.S. states
39
U.S. cities
138
Facility City State ZIP Site status
Cardiology P.C. Birmingham Alabama 35211 —
AMR Daphne Daphne Alabama 36526 —
AMR Mobile Mobile Alabama 36608 —
Mobile Heart Specialists, PC Mobile Alabama 36608 —
The Institute for Liver Health II DBA Arizona Clinical Trials Chandler Arizona 85225 —
Clinical Research Institute of Arizona, LLC Sun City West Arizona 85375 —
AMR Phoenix Tempe Arizona 85281 —
Arizona Liver Health-Tucson-67516 Tucson Arizona 85712 —
Yuma Clinical Trials Yuma Arizona 85364 —
Lynn Institute of the Ozarks Little Rock Arkansas 72204 —
Velocity Clinical Research-Huntington Park Huntington Park California 90255 —
Velocity Clinical Research, San Diego La Mesa California 91942 —
Velocity Clinical Research - Los Angeles Los Angeles California 90017 —
Catalina Research Institute, LLC Montclair California 91763 —
Valley Clinical Trials, Inc. Northridge California 91325 —
NorCal Endocrinology and Internal Medicine San Ramon California 94583 —
Velocity Clinical Research, Santa Ana Santa Ana California 92704 —
NorthBay Clinical Research, LLC Santa Rosa California 95405 —
Velocity Clinical Research-Van Nuys-70286 Van Nuys California 91405 —
Peak Gastroenterology Associates-Colorado Springs-62256 Colorado Springs Colorado 80907 —
Bridgeport Hospital Bridgeport Connecticut 06610 —
CMR of Greater New Haven, LLC Hamden Connecticut 06517 —
Chase Medical Research, LLC Waterbury Connecticut 06708 —
Proactive Clinical Research Boca Raton Florida 33431 —
Excel Medical Clinical Trials Boca Raton Florida 33434 —
Clinical Research of West Florida, Inc. Clearwater Florida 33765 —
Nature Coast Clinical Research-Crystal River-62355 Crystal River Florida 34429 —
Beautiful Minds Clinical Research Center Cutler Bay Florida 33157 —
AMR Fort Myers Fort Myers Florida 33912 —
Covenant Metabolic Specialists, LLC - Fort Myers Fort Myers Florida 33912 —
Velocity Clinical Research-Hallandale Beach-67888 Hallandale Florida 33009 —
Westside Center for Clinical Research Jacksonville Florida 32205 —
Clinical Site Partners LLC Leesburg Florida 34748 —
Flourish Research - Miami Miami Florida 33135 —
Verus Clinical Research Corporation Miami Florida 33135 —
Center for Diabetes, Obesity and Metabolism Pembroke Pines Florida 33024 —
Synexus-Pinellas Park-69294 Pinellas Park Florida 33781 —
East Coast Institute for Research, LLC-Saint Augustine-63032 Saint Augustine Florida 32086 —
Lenus Research & Medical Group Sweetwater Florida 33172 —
Santos Research Center, Corp. Tampa Florida 33615 —
Covenant Metabolic Specialists, LLC - Sarasota University Park Florida 34201 —
Javara-Albany-67356 Albany Georgia 31707 —
Centricity Research Columbus Georgia Multispecialty Columbus Georgia 31904 —
Javara-Fayetteville-67354 Fayetteville Georgia 30214 —
NSC Research Inc Johns Creek Georgia 30024 —
The Jones Center Clinical Research, LLC Macon Georgia 31210 —
Urban Family Practice Associates, PC Marietta Georgia 30067 —
Javara-Savannah-67450 Savannah Georgia 31406 —
Endeavor Health Clinical Operations - Northwest Community Healthcare Arlington Heights Illinois 60005 —
Cedar Crosse Research Center Chicago Illinois 60607 —
Research by Design, LLC Chicago Illinois 60643 —
Medisphere Medical Research Center Evansville Indiana 47714 —
McFarland Clinic PC Ames Iowa 50010 —
Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa 50266 —
AMR El Dorado El Dorado Kansas 67042 —
AMR Newton Newton Kansas 67114 —
AMR Clinical Wichita Wichita Kansas 67226 —
Research Integrity, LLC Owensboro Kentucky 42303 —
Grace Research, LLC-Bossier City-51040 Bossier City Louisiana 71111 —
Heart Clinic of Hammond Hammond Louisiana 70403 —
Tandem Clinical Research Marrero Louisiana 70072 —
AMR New Orleans New Orleans Louisiana 70119 —
Grace Research, LLC-Shreveport-64616 Shreveport Louisiana 71105 —
Javara Inc.-Annapolis-68997 Annapolis Maryland 21401 —
Ascension Saint Agnes Heart Care Baltimore Maryland 21229 —
MD Medical Research Oxon Hill Maryland 20745 —
Brigham and Women's Hospital Boston Massachusetts 02115 —
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 —
Domino's Farms Ann Arbor Michigan 48105 —
Elite Research Center, LLC Flint Michigan 48532 —
Healthy Heart Cardiology Grand Rapids Michigan 49546 —
Mayo Clinic, Rochester Rochester Minnesota 55905 —
The National Diabetes & Obesity Research Institute Diamondhead Mississippi 39525 —
Prime Health and Wellness Fayette Mississippi 39069 —
Velocity Clinical Research-Gulfport-68930 Gulfport Mississippi 39503 —
Johnson County ClinTrials Kansas City Missouri 64112 —
AMR Kansas City Kansas City Missouri 64114 —
Clinvest Research LLC Springfield Missouri 65807 —
Sundance Clinical Research, LLC St Louis Missouri 63141 —
Mercury Street Medical Butte Montana 59701 —
Skyline Medical Center Elkhorn Nebraska 68022 —
Methodist Physicians Clinic Fremont Nebraska 68025 —
AMR Las Vegas Las Vegas Nevada 89119 —
Advanced Heart Care, LLC Bridgewater New Jersey 08807 —
NJ Heart LLC Linden New Jersey 07036 —
IMA Clinical Research-Warren-69742 Warren Township New Jersey 07059 —
IMA Clinical Research Albuquerque Albuquerque New Mexico 87109 —
Velocity Clinical Research - Binghamton Binghamton New York 13905 —
Synexus Clinical Research US, Inc. New York New York 10017 —
Saratoga Clinical Research, LLC Saratoga Springs New York 12866 —
Accellacare of Cary Cary North Carolina 27518 —
The University of North Carolina at Chapel Hill Chapel Hill North Carolina 27514 —
Javara-Charlotte-67884 Charlotte North Carolina 28210 —
Accellacare-Mooresville-69123 Mooresville North Carolina 28117 —
Centricity Research (New Bern) New Bern North Carolina 28562 —
Wake Forest University Health Sciences-Winston-Salem-69719 Winston-Salem North Carolina 27104 —
Velocity Clinical Research-Cincinnati-69044 Cincinnati Ohio 45242 —
Synexus Clinical Research-Columbus-69427 Columbus Ohio 43212 —
Centricity Research-Columbus-68879 Columbus Ohio 43213 —
Aventiv Research Inc.-Dublin-62009 Dublin Ohio 43016 —
Clinical Research Institute of Ohio, LLC Westlake Ohio 44145 —
Tekton Research-Edmond-68875 Edmond Oklahoma 73013 —
AMR Norman Norman Oklahoma 73069 —
Lynn Institute of Norman Norman Oklahoma 73072 —
Lynn Health Science Institute Oklahoma City Oklahoma 73112 —
South Oklahoma Heart Research Group Oklahoma City Oklahoma 73135 —
Velocity Clinical Research-Medford-69053 Medford Oregon 97504 —
Heritage Valley Medical Group Beaver Pennsylvania 15009 —
Capital Area Research, LLC Camp Hill Pennsylvania 17011 —
Tristar Clinical Investigations PC Philadelphia Pennsylvania 19114 —
Preferred Primary Care Physicians-Pittsburgh-63932 Pittsburgh Pennsylvania 15236 —
Preferred Primary Care Physicians-Uniontown-69137 Uniontown Pennsylvania 15401 —
Velocity Clinical Research-East Greenwich-68873 East Greenwich Rhode Island 02818 —
Synexus - Anderson Anderson South Carolina 29621 —
Velocity Clinical Research-Anderson-69093 Anderson South Carolina 29621 —
Velocity Clinical Research-Gaffney-69046 Gaffney South Carolina 29340 —
Tribe Clinical Research LLC - Greenville Greenville South Carolina 29607 —
Velocity Clinical Research-Greenville-69045 Greenville South Carolina 29615 —
Coastal Carolina Research Center North Charleston South Carolina 29405 —
Velocity Clinical Research-Union-68888 Union South Carolina 29379 —
Internal Medicine and Pediatric Associates of Bristol, PC Bristol Tennessee 37620 —
Chattanooga Research & Medicine, PLLC Chattanooga Tennessee 37404 —
Alliance for Multispecialty Research, LLC-Knoxville-69693 Knoxville Tennessee 37909 —
Accellacare of Knoxville-Knoxville-69135 Knoxville Tennessee 37912 —
Accellacare of Knoxville-Knoxville-69714 Knoxville Tennessee 37938 —
Clinical Neuroscience Solutions, Inc-Memphis-65988 Memphis Tennessee 38119 —
Clinical Research Associates, Inc Nashville Tennessee 37203 —
Amarillo Medical Specialists Amarillo Texas 79124 —
Velocity Clinical Research, Austin Austin Texas 78759 —
Headlands Research - Brownsville Brownsville Texas 78526 —
Privia Medical Group Gulf Coast, PLLC Conroe Texas 77384 —
Velocity Clinical Research-Dallas-69170 Dallas Texas 75230 —
Javara Inc. - Fort Worth Fort Worth Texas 76133 —
Houston Research Institute Houston Texas 77079 —
IMA Clinical Research San Antonio San Antonio Texas 78229 —
Tekton Research-San Antonio-68916 San Antonio Texas 78258 —
Javara Inc. and Privia Medical Group Gulf Coast, PLLC San Marcos Texas 78666 —
Javara Inc.-Stephenville-68996 Stephenville Texas 76401 —
DM Clinical Research - Martin Diagnostic Clinic Tomball Texas 77375 —
Velocity Clinical Research, Waco Waco Texas 76710 —
Physicians' Research Options. LLC Draper Utah 84020 —
Alliance for Multispecialty Research, LLC-Layton-69691 Layton Utah 84041 —
Synexus Clinical Research-Salt Lake City-69293 Salt Lake City Utah 84106 —
Chrysalis Clinical Research St. George Utah 84790 —
Velocity Clinical Research-West Jordan-69043 West Jordan Utah 84088 —
Washington Center for Weight Management and Research, Inc. Arlington Virginia 22206 —
Seven Corners Medical Center Falls Church Virginia 22044 —
Eastern Virginia Medical School Norfolk Virginia 23510 —
Selma Medical Associates, Winchester Winchester Virginia 22601 —
Velocity Clinical Research, Seattle Seattle Washington 98105 —
Velocity Clinical Research-Spokane-69716 Spokane Washington 99218 —
Clinical Investigation Specialists, Inc.-Kenosha-69111 Kenosha Wisconsin 53144 —
Allegiance Research Specialists Wauwatosa Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 387 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06077864, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 30, 2026 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06077864 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →