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HomeTrials › NCT05556512

Obesity & weight · Phase 3 · Active, not recruiting

A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity

NCT05556512 · Sponsor: Eli Lilly and Company

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 Tirzepatide, Placebo for obesity, overweight.

Who can joinAll sexes, 40 Years and older
Healthy volunteersNo — diagnosis required
What you'd takeTirzepatide, Placebo
Study length~5 years overall
Planned participants15,374
TypeInterventional (you receive treatment)

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 will investigate the effect of tirzepatide on the reduction of morbidity and mortality in adults living with obesity and provide additional evidence for the potential clinical benefits of tirzepatide in this population.

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: * Have a body mass index (BMI) ≥27.0 kilogram/square meter (kg/m ²) * Are either * individuals ≥40 years of age with established cardiovascular disease (CVD). * CVD is defined as meeting at least one of the following: * Coronary artery disease * Cerebrovascular disease * Peripheral arterial disease OR * individuals without established CVD but have the presence of cardiovascular (CV) risk factors (primary prevention) * women 55-69 years of age or men 50-64 years of age with at least 3 risk factors like tobacco use, dyslipidemia, hypertension at screening, or * women ≥70 years of age or men, ≥65 years of age with at least 2 risk factors at screening. Exclusion Criteria: * Have type 1 diabetes (T1D) or (T2D), history of ketoacidosis, or hyperosmolar state/coma * Have laboratory evidence diagnostic of diabetes mellitus at screening of HbA1c ≥6.5% (≥48 millimole/mole (mmol/mol) or fasting glucose (FG) ≥126 milligram/deciliter (≥7.0 millimole/liter (mmol/L). * Any one of the following CV conditions within 90 days prior to screening * MI * acute coronary syndrome * stroke * coronary or peripheral arterial revascularization procedure, which may also include carotid artery revascularization, or * acute decompensated heart failure * Have a known clinically significant gastric emptying abnormality such as severe gastroparesis or gastric outlet obstruction or have undergone or currently planning any gastric bypass (metabolic) surgery or restrictive bariatric surgery. Note: Liposuction or abdominoplasty are not considered as gastric bypass procedures. * Have a history of chronic or acute pancreatitis * Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. * Have acute or chronic hepatitis, or clinical signs or symptoms of any other liver disease, or have elevated liver enzyme measurements, determined by the central laboratory at screening * Have a presence or history of malignant neoplasms within the past 5 years prior to screening.

Study sites by state

Arizona

  • Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC — Gilbert
  • Aventiv Research — Mesa
  • Elite Clinical Studies — Phoenix
  • Pima Heart — Tucson

Arkansas

  • KLR Business Group, Inc. dba Arkansas Clinical Research — Little Rock

California

  • Smart Cures Clinical Research — Anaheim
  • Kidney & Hypertension Center - Apple Valley — Apple Valley
  • Hope Clinical Research, Inc. — Canoga Park
  • John Muir Physician Network Research Center — Concord
  • Neighborhood Healthcare Institute of Health — Escondido
  • HB Clinical Trials - Fountain Valley — Fountain Valley
  • Valiance Clinical Research — Huntington Park
  • Scripps Whittier Diabetes Institute — La Jolla
  • Velocity Clinical Research, San Diego — La Mesa
  • First Valley Medical Group — Lancaster
  • Long Beach Clinical Trials — Long Beach
  • Infinity Clinical Research - Norco — Norco
  • California Medical Research Associates — Northridge
  • Diabetes Associates Medical Group — Orange
  • University of California Irvine Medical Center — Orange
  • FOMAT Medical Research — Oxnard
  • Desert Oasis Healthcare Medical Group — Palm Springs
  • Dream Team Clinical Research — Pomona
  • Rancho Cucamonga Clinical Research — Rancho Cucamonga
  • Artemis Institute for Clinical Research — Riverside
  • Artemis Institute for Clinical Research — San Diego
  • Acclaim Clinical Research — San Diego
  • Velocity Clinical Research, Santa Ana — Santa Ana
  • Valiance Clinical Research — Tarzana
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance
  • Diablo Clinical Research, Inc. — Walnut Creek
  • Millennium Clinical Trials — Westlake Village

Colorado

  • University of Colorado Anschutz Medical Campus — Aurora
  • Optum- Southwestern — Colorado Springs
  • Kidney Associates of Colorado — Denver
  • OptumCare Clinical Trials, LLC — Golden

Connecticut

  • Clinical Research Consulting — Milford
  • Cardiology Associates of Fairfield County, P.C. — Stamford
  • Chase Medical Research, LLC — Waterbury

Florida

  • Excel Medical Clinical Trials — Boca Raton
  • Encore Medical Research of Boynton Beach — Boynton Beach
  • Clinical Research of West Florida, Inc. (Clearwater) — Clearwater
  • Northeast Research Institute (NERI) — Fleming Island
  • Indago Research & Health Center, Inc — Hialeah
  • Northeast Research Institute - Downtown Office — Jacksonville
  • IHS Health Research — Kissimmee
  • Clinical Research of Central Florida — Lakeland
  • South Florida Clinical Research Institute — Margate
  • Felicidad Medical Research — Miami
  • Floridian Clinical Research, LLC — Miami Lakes
  • Florida Institute For Clinical Research, LLC — Orlando
  • Peace River Cardiovascular Center — Port Charlotte
  • Northeast Research Institute - St. Augustine — Saint Augustine
  • IMA Clinical Research St. Petersburg — St. Petersburg
  • Clinical Research of West Florida — Tampa
  • Metabolic Research Institute, Inc. — West Palm Beach

Georgia

  • Masters of Clinical Research — Augusta
  • HOPE Clinical Research & Wellness — Conyers
  • Center for Advanced Research & Education — Gainesville
  • NSC Research — Johns Creek
  • Balanced Life Health Care Solutions/SKYCRNG — Lawrenceville
  • WR-Mount Vernon Clinical Research, LLC — Sandy Springs
  • Rophe Adult and Pediatric Medicine/SKYCRNG — Union City
  • North Georgia Clinical Research — Woodstock

Hawaii

  • East-West Medical Research Institute — Honolulu

Idaho

  • Elite Clinical Trials — Blackfoot
  • Rocky Mountain Clinical Research — Idaho Falls
  • Velocity Clinical Research, Boise — Meridian
  • Solaris Clinical Research — Meridian

Illinois

  • IMA Clinical Research Chicago — Chicago
  • Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative — Springfield
  • Healthcare Research Network - Chicago — Tinley Park

Indiana

  • American Health Network of Indiana, LLC - Avon — Avon
  • Qualmedica Research, LLC — Evansville
  • American Health Network of Indiana, LLC - Franklin — Franklin
  • American Health Network of Indiana, LLC - Greenfield — Greenfield

Iowa

  • Iowa Diabetes and Endocrinology Research Center — West Des Moines

Kansas

  • Cotton O'Neil Diabetes & Endocrinology — Topeka
  • Cotton O'Neil Mulvane — Topeka

Kentucky

  • Qualmedica Research — Bowling Green
  • L-MARC Research Center — Louisville
  • Qualmedica Research, LLC — Owensboro

Maryland

  • Ascension Saint Agnes Heart Care — Baltimore
  • Centennial Medical Group — Columbia

Massachusetts

  • Massachusetts General Hospital — Boston
  • Brigham and Women's Hospital Diabetes Program — Boston
  • NECCR PrimaCare Research — Fall River
  • ActivMed Practices and Research — Methuen

Michigan

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division — Troy

Minnesota

  • M Health Fairview St. John's Hospital — Maplewood

Mississippi

  • The National Diabetes & Obesity Research Institute — Diamondhead
  • Prime Health and Wellness/SKYCRNG — Fayette
  • Olive Branch Family Medical Center — Olive Branch
  • SKY Integrative Medical Center/SKYCRNG — Ridgeland

Missouri

  • StudyMetrix Research — City of Saint Peters
  • Healthcare Research Network - St. Louis — Hazelwood
  • Clinvest Research LLC — Springfield
  • IMA Clinical Research - St. Louis — St Louis

Montana

  • Billings Clinic — Billings

Nebraska

  • VA Nebraska-Western Iowa Health Care System — Omaha

Nevada

  • DaVita Clinical Research - Las Vegas — Las Vegas
  • Excel Clinical Research, LLC — Las Vegas
  • Palm Research Center Tenaya — Las Vegas
  • Palm Research Center Sunset — Las Vegas
  • Advanced Research Institute - Reno — Reno

New Jersey

  • UniMed Center — East Brunswick
  • NJ MedCare & NJ Heart — Linden
  • Hassman Research Institute Marlton Site — Marlton
  • IMA Clinical Research Warren — Warren Township

New Mexico

  • IMA Clinical Research — Albuquerque

New York

  • Albany Medical College, Division of Community Endocrinology — Albany
  • Meridian Clinical Research, LLC — Binghamton
  • NYU Langone Health — New York
  • IMA Clinical Research — New York
  • Rochester Clinical Research, LLC — Rochester
  • Meridian Clinical Research, LLC — Vestal

North Dakota

  • Lillestol Research — Fargo

Ohio

  • Aventiv Research Inc — Columbus

Oklahoma

  • Alliance for Multispecialty Research, LLC — Norman

Oregon

  • The Corvallis Clinic, P.C. — Corvallis

Pennsylvania

  • Heritage Valley Medical Group, Inc. — Beaver
  • Capital Area Research, LLC — Camp Hill
  • Thomas Jefferson University Hospital — Philadelphia
  • Tristar Clinical Investigations — Philadelphia
  • Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair — Pittsburgh
  • Cardiology Consultants of Philadelphia Yardley — Yardley

Tennessee

  • WR-Clinsearch, LLC — Chattanooga

Texas

  • Texas Diabetes & Endocrinology, P.A. — Austin
  • Pinnacle Clinical Research — Austin
  • Dallas Diabetes Research Center — Dallas
  • Soma Clinical Trials — Denison
  • Medresearch Inc — El Paso
  • Diabetes and Thyroid Center of Ft. Worth — Fort Worth
  • Valley Institute of Research - Fort Worth — Fort Worth
  • AngioCardiac Care of Texas, PA — Houston
  • Houston Methodist Hospital — Houston
  • Biopharma Informatic, LLC — Houston
  • Next Level Urgent Care — Houston
  • Biopharma Informatic, LLC — Houston
  • Research Physicians Network, LLC — Houston
  • Epic Clinical Research — Lewisville
  • Texas Institute for Kidney and Endocrine Disorders — Lufkin
  • Biopharma Informatic, LLC — McAllen
  • Texas Institute of Cardiology, PA — McKinney
  • Southern Endocrinology Associates — Mesquite
  • North Hills Family Medicine/North Hills Medical Research — North Richland Hills
  • Clinical Trials of Texas, LLC — San Antonio
  • Pinnacle Clinical Research — San Antonio
  • VIP Trials — San Antonio
  • Consano Clinical Research, LLC — Shavano Park
  • DaVita Clinical Research - North Houston — Shenandoah
  • Northwest Houston Heart Center — Tomball
  • Impact Research Institute — Waco
  • Texas Valley Clinical Research — Weslaco
  • Soma Clinical Trials — Wylie

Utah

  • Advanced Research Institute — Ogden
  • Advanced Research Institute - Sandy — Sandy City
  • Kalo Clinical Research — West Valley City

Virginia

  • Dominion Medical Associates, Inc. — Richmond
  • National Clinical Research, Inc — Richmond

Washington

  • Eastside Research Associates — Redmond
  • Rainier Clinical Research Center — Renton
  • Central Washington Health Services Association d/b/a Confluence Health — Wenatchee

West Virginia

  • IMA Clinical Research — Morgantown

Wisconsin

  • St. Vincent Hospital d/b/a Prevea Health — Green Bay

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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