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Phase 3Recruiting

A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)

Sponsored by Eli Lilly and Company

About this study

The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD). The study will enroll adults who have MASLD based on non-invasive tests (NITs), which indicate they are more likely to develop MALO. Participants will be randomly assigned within a Master Protocol to receive either retatrutide (N1T-MC-RT01), tirzepatide (N1T-MC-TZ01) or placebo. The trial plans to enroll about 4,500 adults and will run for approximately 224 weeks. Participants may have up to approximately 25 to 30 clinic visits throughout the study to monitor their health, complete study procedures, and assess liver function and disease progression. Once the study is complete, eligible participants may participate in an optional 2-year extension study, in which all participants will receive either retatrutide or tirzepatide, even if they received placebo in the main study.

Where this study is enrolling (106)

  • MFA Clinical Research

    Tuscaloosa, Alabama

    Call 205-331-4963

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  • The Institute for Liver Health II dba Arizona Clinical Trials - Chandler

    Chandler, Arizona

    Call 480-360-4000

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  • The Institute for Liver Health II dba Arizona Liver Health - Peoria

    Peoria, Arizona

    Call 480-470-4000

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  • Del Sol Research Management, LLC

    Tucson, Arizona

    Call (520) 257-3881

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  • The Institute for Liver Health II dba Arizona Clinical Trials - Tucson

    Tucson, Arizona

    Call 480-360-4000

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Show all 106 locations

  • Ark Clinical Research

    Long Beach, California

    Call 562-997-1000

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  • Los Angeles Institute for Metabolic Research

    Los Angeles, California

    Call 213-373-8380

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  • United Medical Doctors - Murrieta

    Murrieta, California

    Call 951-566-5229

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  • Knowledge Research Center

    Orange, California

    Call 657-247-0087

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  • California Liver Research Center

    Pasadena, California

    Call 626-795-5769

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  • Quest Clinical Research

    San Francisco, California

    Call 415-353-0800

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  • Artemis Institute for Clinical Research

    Riverside, California

    Call 951-374-1190

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  • San Fernando Valley Health Institute

    Canoga Park, California

    Call 818-222-6868

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  • Ark Clinical Research - Fountain Valley

    Fountain Valley, California

    Call 714-988-2021

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  • Fresno Clinical Research Center

    Fresno, California

    Call 559-970-3441

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  • UCSD - Altman Clinical and Translational Research Institute (ACTRI)

    La Jolla, California

    Call 858-246-2227

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  • Orange County Research Center

    Lake Forest, California

    Call 714-550-9990

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  • Om Research LLC

    Lancaster, California

    Call 661-388-2239

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  • Medical Associates Research Group

    San Diego, California

    Call 858-277-5678

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  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado

    Call 303-724-4651

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  • K2 Medical Research WINTER GARDEN

    Clermont, Florida

    Call 407-426-9299

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  • Southwest General Healthcare Center

    Fort Myers, Florida

    Call 239-931-3368

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  • University of Florida College of Medicine

    Gainesville, Florida

    Call 352-273-8662

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  • Encore Medical Research

    Hollywood, Florida

    Call 954-400-1725

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  • Nature Coast Clinical Research - Inverness

    Inverness, Florida

    Call 352-341-2100

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  • Encore Borland-Groover Clinical Research

    Jacksonville, Florida

    Call 904-680-0871

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  • K2 MEDICAL Research THE VILLAGES

    Lady Lake, Florida

    Call 352-500-5252

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  • Florida Research Institute

    Lakewood Rch, Florida

    Call 941-727-7772

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  • Tampa Bay Medical Research - Largo

    Largo, Florida

    Call 727-724-3316

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  • Evolution Clinical Trials

    Miami, Florida

    Call 786-706-1216

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  • Floridian Clinical Research, LLC

    Miami Lakes, Florida

    Call 305-330-9977

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  • GI PROS Research

    Naples, Florida

    Call 239-571-0899

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  • Headlands Research Orlando

    Orlando, Florida

    Call 407-705-3471

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  • Progressive Medical Research

    Port Orange, Florida

    Call 386-304-7070

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  • Covenant Metabolic Specialists - Riverview

    Riverview, Florida

    Call 941-894-2014

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  • Care Access - St. Petersburg

    St. Petersburg, Florida

    Call 877-791-0656

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  • Care Access - Tamarac

    Tamarac, Florida

    Call 877-791-0656

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  • Covenant Metabolic Specialists, LLC

    University Park, Florida

    Call 941-894-2014

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  • Care Access - Delray Beach

    Delray Beach, Florida

    Call 401-773-7855

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  • Gastrointestinal Specialists of Georgia

    Marietta, Georgia

    Call 678-741-5000

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  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia

    Call 470-317-3604

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  • Southeast Clinical Research Center

    Dalton, Georgia

    Call 706-913-1779

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  • University of Chicago Medical Center

    Chicago, Illinois

    I'm interested

  • Digestive Research Alliance of Michiana

    South Bend, Indiana

    Call 574-904-9617

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  • Indiana University Health University Hospital

    Indianapolis, Indiana

    Call 317-278-1652

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  • Gastroenterology Health Partners

    New Albany, Indiana

    Call 812-206-1702

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  • Deaconess Clinic- Gateway

    Newburgh, Indiana

    Call 812-490-4505

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  • AMR Clinical

    El Dorado, Kansas

    Call 316-600-5127 EXT 301

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  • Cotton O'Neil Digestive Health Center

    Topeka, Kansas

    Call 785-368-0477

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  • Louisiana Research Center

    Shreveport, Louisiana

    Call 318-525-3233

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  • Tandem Clinical Research

    Marrero, Louisiana

    Call 504-934-8424

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  • Delta Research Partners of Bastrop, LLC

    Bastrop, Louisiana

    Call 318-281-6040

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  • Care Access - New Iberia

    New Iberia, Louisiana

    Call 813-851-0135

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  • Capital Digestive Care - Chevy Chase

    Chevy Chase, Maryland

    Call 301-841-6869

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  • Mercy Medical Center - Baltimore

    Baltimore, Maryland

    Call 410-332-9356

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  • Clinical Research Institute of Michigan, LLC

    Clinton Township, Michigan

    Call 586-598-3329

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  • Great Lakes Research Institute

    Southfield, Michigan

    Call 248-864-5242

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  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, Michigan

    Call 248-312-0025

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  • GI Associates - GIA and Endoscopy Center - Flowood

    Flowood, Mississippi

    Call 601-863-0395

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  • Jubilee Clinical Research NV. LLC

    Las Vegas, Nevada

    Call 702-631-5000

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  • Excel Clinical Research, LLC

    Las Vegas, Nevada

    Call 702-680-1500

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  • Atlantic Health System Morristown Medical Center

    Morristown, New Jersey

    Call 973-971-7507

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  • Clinical Research of Philadelphia

    Pennington, New Jersey

    Call 215-676-6696

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  • The Cognitive and Research Center of New Jersey - Ridgewood

    Ridgewood, New Jersey

    Call 201-850-4622

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  • Research Foundation of SUNY - University of Buffalo

    Buffalo, New York

    Call 716-535-1850

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  • NYU Langone Health

    New York, New York

    Call 646-501-2948

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  • Carteret Medical Group

    Morehead City, North Carolina

    Call 252-499-8623

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  • Monroe Biomedical Research

    Monroe, North Carolina

    Call 704-283-7359

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  • CRIOH

    Westlake, Ohio

    Call 440-363-4000

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  • Clinical Research Institute of Ohio - Brooklyn

    Brooklyn, Ohio

    Call 440-363-4000

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  • Dayton Gastroenterology - Beavercreek

    Beavercreek, Ohio

    Call 937-320-5050

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  • US Digestive Health - Wyomissing

    Wyomissing, Pennsylvania

    Call 610-374-4401

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  • US Digestive Health - Flourtown

    Flourtown, Pennsylvania

    Call 215-664-4362

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  • Galen Medical Group - Galen Hepatology

    Chattanooga, Tennessee

    Call 423-954-9015

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  • Care United Research, LLC

    Forney, Texas

    Call 972-564-0044

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  • South Texas Research Institute

    Edinburg, Texas

    Call 956-468-3360

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  • Biopharma Informatic, LLC

    Houston, Texas

    I'm interested

  • Epic Medical Research - DeSoto

    DeSoto, Texas

    Call 197-277-7695

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  • GI Alliance - Fort Worth

    Fort Worth, Texas

    Call 817-612-5575

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  • Care Access - Houston

    Houston, Texas

    Call 617-843-2781

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  • Houston Research Institute

    Houston, Texas

    I'm interested

  • Research Physicians Network, LLC

    Houston, Texas

    Call 281-944-3610

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  • Biopharma Informatic, LLC

    McAllen, Texas

    Call 281-944-3610

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  • DHR Health Institute for Research and Development (Administrative Office & Laboratory)

    McAllen, Texas

    Call 956-362-2390

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  • Southern Endocrinology Associates

    Mesquite, Texas

    Call 214-693-0904

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  • HRI Pasadena

    Pasadena, Texas

    Call 713-475-5555

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  • Clinical Trials of Texas, LLC dba Flourish Research

    San Antonio, Texas

    Call 210-949-0122

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  • IMA Clinical Research San Antonio

    San Antonio, Texas

    Call 210-692-7157

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  • Consano Clinical Research, LLC

    Shavano Park, Texas

    Call 210-545-4900

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  • GI Alliance - Southlake

    Southlake, Texas

    Call 940-367-2316

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  • Houston Research Institute (HRI) - Sugar Land

    Sugar Land, Texas

    Call (832) 707-5011

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  • Texas Valley Clinical Research

    Weslaco, Texas

    Call 956-431-8090

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  • Medrasa Clinical Research

    Wylie, Texas

    Call 469-449-3645

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  • American Research Corporation at Texas Liver Institute

    San Antonio, Texas

    Call 210-253-3426

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  • Soma Clinical Trials

    Denison, Texas

    Call 469-819-0228

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  • South Texas Research Institute - Brownsville

    Brownsville, Texas

    Call 956-468-3360

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  • Pinnacle Clinical Research

    Austin, Texas

    Call 512-384-1460 x3001

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  • American Research Corporation

    Austin, Texas

    Call 210-253-3426

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  • IMA Clinical Research Austin

    Austin, Texas

    Call 512-649-0082

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  • Dallas Research Institute

    Farmers Branch, Texas

    Call 214-347-7577

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  • Advanced Research Institute - Sandy

    Sandy City, Utah

    Call 801-409-2040

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  • Care Access - Ogden

    Ogden, Utah

    Call 801-614-0010

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  • Virginia Commonwealth University (VCU) Medical Center

    Richmond, Virginia

    Call 804-828-4060

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  • Washington Gastroenterology - Tacoma

    Tacoma, Washington

    Call 253-272-5127

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  • Washington Gastroenterology - Bellevue

    Bellevue, Washington

    Call 425-454-4768

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  • CAMC Health Education and Research Institute Inc

    Charleston, West Virginia

    Call 304-388-9944

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Who can participate

Inclusion criteria

  • ✓Have liver fat content ≥8%
  • ✓Have ELF score of ≥9 and ≤10.8 at screening
  • ✓Have VCTE LSM ≥10 kilopascal (kPa) and \<20 kPa at screening

Exclusion criteria

  • ✕Have any other type of liver disease other than MASLD
  • ✕Have a body mass index (BMI) \<25 kilogram per square meter (kg/m2)
  • ✕Prior decompensated liver disease (history of esophageal/gastric varices, ascites, hepatic encephalopathy)
  • ✕Have lost more than 11 pounds within the 3 months prior to screening
  • ✕Have a hemoglobin A1c (HbA1c) greater than 10%
  • ✕Have type 1 diabetes

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.