What this trial means for you
This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying survodutide, Placebo for obesity.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
Inclusion Criteria: 1. 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. 2. 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. Exclusion criteria: 1. Previous treatment with glucagon-like peptide-1 receptor (GLP-1R) agonists within 3 months before screening. 2. Type 1 diabetes. 3. 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. 4. Known clinically significant gastric emptying abnormality (e.g., severe diabetic gastroparesis or gastric outlet obstruction). Further exclusion criteria apply.
Study sites by state
Alabama
- Cardiology P.C. — Birmingham
- AMR Daphne — Daphne
- AMR Mobile — Mobile
- Mobile Heart Specialists, PC — Mobile
Arizona
- The Institute for Liver Health II DBA Arizona Clinical Trials — Chandler
- Clinical Research Institute of Arizona, LLC — Sun City West
- AMR Phoenix — Tempe
- Arizona Liver Health-Tucson-67516 — Tucson
- Yuma Clinical Trials — Yuma
Arkansas
- Lynn Institute of the Ozarks — Little Rock
California
- Velocity Clinical Research-Huntington Park — Huntington Park
- Velocity Clinical Research, San Diego — La Mesa
- Velocity Clinical Research - Los Angeles — Los Angeles
- Catalina Research Institute, LLC — Montclair
- Valley Clinical Trials, Inc. — Northridge
- NorCal Endocrinology and Internal Medicine — San Ramon
- Velocity Clinical Research, Santa Ana — Santa Ana
- NorthBay Clinical Research, LLC — Santa Rosa
- Velocity Clinical Research-Van Nuys-70286 — Van Nuys
Colorado
- Peak Gastroenterology Associates-Colorado Springs-62256 — Colorado Springs
Connecticut
- Bridgeport Hospital — Bridgeport
- CMR of Greater New Haven, LLC — Hamden
- Chase Medical Research, LLC — Waterbury
Florida
- Proactive Clinical Research — Boca Raton
- Excel Medical Clinical Trials — Boca Raton
- Clinical Research of West Florida, Inc. — Clearwater
- Nature Coast Clinical Research-Crystal River-62355 — Crystal River
- Beautiful Minds Clinical Research Center — Cutler Bay
- AMR Fort Myers — Fort Myers
- Covenant Metabolic Specialists, LLC - Fort Myers — Fort Myers
- Velocity Clinical Research-Hallandale Beach-67888 — Hallandale
- Westside Center for Clinical Research — Jacksonville
- Clinical Site Partners LLC — Leesburg
- Flourish Research - Miami — Miami
- Verus Clinical Research Corporation — Miami
- Center for Diabetes, Obesity and Metabolism — Pembroke Pines
- Synexus-Pinellas Park-69294 — Pinellas Park
- East Coast Institute for Research, LLC-Saint Augustine-63032 — Saint Augustine
- Lenus Research & Medical Group — Sweetwater
- Santos Research Center, Corp. — Tampa
- Covenant Metabolic Specialists, LLC - Sarasota — University Park
Georgia
- Javara-Albany-67356 — Albany
- Centricity Research Columbus Georgia Multispecialty — Columbus
- Javara-Fayetteville-67354 — Fayetteville
- NSC Research Inc — Johns Creek
- The Jones Center Clinical Research, LLC — Macon
- Urban Family Practice Associates, PC — Marietta
- Javara-Savannah-67450 — Savannah
Illinois
- Endeavor Health Clinical Operations - Northwest Community Healthcare — Arlington Heights
- Cedar Crosse Research Center — Chicago
- Research by Design, LLC — Chicago
Indiana
- Medisphere Medical Research Center — Evansville
Iowa
- McFarland Clinic PC — Ames
- Iowa Diabetes and Endocrinology Research Center — West Des Moines
Kansas
- AMR El Dorado — El Dorado
- AMR Newton — Newton
- AMR Clinical Wichita — Wichita
Kentucky
- Research Integrity, LLC — Owensboro
Louisiana
- Grace Research, LLC-Bossier City-51040 — Bossier City
- Heart Clinic of Hammond — Hammond
- Tandem Clinical Research — Marrero
- AMR New Orleans — New Orleans
- Grace Research, LLC-Shreveport-64616 — Shreveport
Maryland
- Javara Inc.-Annapolis-68997 — Annapolis
- Ascension Saint Agnes Heart Care — Baltimore
- MD Medical Research — Oxon Hill
Massachusetts
- Brigham and Women's Hospital — Boston
- Beth Israel Deaconess Medical Center — Boston
Michigan
- Domino's Farms — Ann Arbor
- Elite Research Center, LLC — Flint
- Healthy Heart Cardiology — Grand Rapids
Minnesota
- Mayo Clinic, Rochester — Rochester
Mississippi
- The National Diabetes & Obesity Research Institute — Diamondhead
- Prime Health and Wellness — Fayette
- Velocity Clinical Research-Gulfport-68930 — Gulfport
Missouri
- Clinical Research Consultants, LLC — Kansas City
- AMR Kansas City — Kansas City
- Clinvest Research LLC — Springfield
- Sundance Clinical Research, LLC — St Louis
Montana
- Mercury Street Medical — Butte
Nebraska
- Skyline Medical Center — Elkhorn
- Methodist Physicians Clinic — Fremont
Nevada
- AMR Las Vegas — Las Vegas
New Jersey
- Advanced Heart Care, LLC — Bridgewater
- NJ Heart LLC — Linden
- IMA Clinical Research-Warren-69742 — Warren Township
New Mexico
- IMA Clinical Research Albuquerque — Albuquerque
New York
- Velocity Clinical Research - Binghamton — Binghamton
- Synexus Clinical Research US, Inc. — New York
- Saratoga Clinical Research, LLC — Saratoga Springs
North Carolina
- Accellacare of Cary — Cary
- The University of North Carolina at Chapel Hill — Chapel Hill
- Javara-Charlotte-67884 — Charlotte
- Accellacare-Mooresville-69123 — Mooresville
- Centricity Research (New Bern) — New Bern
- Wake Forest University Health Sciences-Winston-Salem-69719 — Winston-Salem
Ohio
- Velocity Clinical Research-Cincinnati-69044 — Cincinnati
- Synexus Clinical Research-Columbus-69427 — Columbus
- Centricity Research-Columbus-68879 — Columbus
- Aventiv Research Inc.-Dublin-62009 — Dublin
- Clinical Research Institute of Ohio, LLC — Westlake
Oklahoma
- Tekton Research-Edmond-68875 — Edmond
- AMR Norman — Norman
- Lynn Institute of Norman — Norman
- Lynn Health Science Institute — Oklahoma City
- South Oklahoma Heart Research Group — Oklahoma City
Oregon
- Velocity Clinical Research-Medford-69053 — Medford
Pennsylvania
- Heritage Valley Medical Group — Beaver
- Capital Area Research, LLC — Camp Hill
- Tristar Clinical Investigations PC — Philadelphia
- Preferred Primary Care Physicians-Pittsburgh-63932 — Pittsburgh
- Preferred Primary Care Physicians-Uniontown-69137 — Uniontown
Rhode Island
- Velocity Clinical Research-East Greenwich-68873 — East Greenwich
South Carolina
- Synexus - Anderson — Anderson
- Velocity Clinical Research-Anderson-69093 — Anderson
- Velocity Clinical Research-Gaffney-69046 — Gaffney
- Tribe Clinical Research LLC — Greenville
- Velocity Clinical Research-Greenville-69045 — Greenville
- Coastal Carolina Research Center — North Charleston
- Velocity Clinical Research-Union-68888 — Union
Tennessee
- Internal Medicine and Pediatric Associates of Bristol, PC — Bristol
- Chattanooga Research & Medicine, PLLC — Chattanooga
- Alliance for Multispecialty Research, LLC-Knoxville-69693 — Knoxville
- Accellacare of Knoxville-Knoxville-69135 — Knoxville
- Accellacare of Knoxville-Knoxville-69714 — Knoxville
- Clinical Neuroscience Solutions, Inc-Memphis-65988 — Memphis
- Clinical Research Associates, Inc — Nashville
Texas
- Amarillo Medical Specialists — Amarillo
- Velocity Clinical Research, Austin — Austin
- Headlands Research — Brownsville
- Privia Medical Group Gulf Coast, PLLC — Conroe
- Velocity Clinical Research-Dallas-69170 — Dallas
- Javara Inc. - Fort Worth — Fort Worth
- Houston Research Institute — Houston
- IMA Clinical Research San Antonio — San Antonio
- Tekton Research-San Antonio-68916 — San Antonio
- Javara Inc. and Privia Medical Group Gulf Coast, PLLC — San Marcos
- Javara Inc.-Stephenville-68996 — Stephenville
- DM Clinical Research - Martin Diagnostic Clinic — Tomball
- Velocity Clinical Research, Waco — Waco
Utah
- Physicians' Research Options. LLC — Draper
- Alliance for Multispecialty Research, LLC-Layton-69691 — Layton
- Synexus Clinical Research-Salt Lake City-69293 — Salt Lake City
- Chrysalis Clinical Research — St. George
- Velocity Clinical Research-West Jordan-69043 — West Jordan
Virginia
- Washington Center for Weight Management and Research, Inc. — Arlington
- Seven Corners Medical Center — Falls Church
- Eastern Virginia Medical School — Norfolk
- Selma Medical Associates, Winchester — Winchester
Washington
- Velocity Clinical Research, Seattle — Seattle
- Velocity Clinical Research-Spokane-69716 — Spokane
Wisconsin
- Clinical Investigation Specialists, Inc.-Kenosha-69111 — Kenosha
- Allegiance Research Specialists — Wauwatosa
View the official record on ClinicalTrials.gov →
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