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

Purpose

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.

Condition

  • Metabolic Dysfunction-Associated Steatotic Liver Disease

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tirzepatide (TZ01) 		Participants will receive tirzepatide subcutaneously (SC)
  • Drug: Tirzepatide
    Administered SC
    Other names:
    • LY3298176
Placebo Comparator
Placebo (TZ01) 		Participants will receive placebo SC
  • Drug: Placebo
    Administered SC
Experimental
Retatrutide (RT01) 		Participants will receive retatrutide SC
  • Drug: Retatrutide
    Administered SC
    Other names:
    • LY3437943
Placebo Comparator
Placebo (RT01) 		Participants will receive placebo SC
  • Drug: Placebo
    Administered SC

Recruiting Locations

The Institute for Liver Health II dba Arizona Clinical Trials - Chandler
Chandler, Arizona 85224

Spectrum Research Institute
Gilbert, Arizona 85297

The Institute for Liver Health II dba Arizona Liver Health - Peoria
Peoria, Arizona 85381

Epic Medical Research-Sun City
Sun City, Arizona 85351

The Institute for Liver Health II dba Arizona Clinical Trials - Tucson
Tucson, Arizona 85712

Del Sol Research Management, LLC
Tucson, Arizona 85715
Contact:
520-257-3881

Arkansas Gastroenterology - North Little Rock
North Little Rock, Arkansas 72117

San Fernando Valley Health Institute
Canoga Park, California 91304
Contact:
818-222-6868

Ark Clinical Research - Fountain Valley
Fountain Valley, California 92708
Contact:
714-988-2021

Fresno Clinical Research Center
Fresno, California 93720
Contact:
559-970-3441

Om Research LLC
Lancaster, California 93534
Contact:
661-388-2239

Ark Clinical Research
Long Beach, California 90815
Contact:
562-997-1000

Los Angeles Institute for Metabolic Research
Los Angeles, California 90015
Contact:
213-373-8380

United Medical Doctors - Murrieta
Murrieta, California 92563
Contact:
951-566-5229

Knowledge Research Center
Orange, California 92868
Contact:
657-247-0087

California Liver Research Center
Pasadena, California 91105
Contact:
626-795-5769

Artemis Institute for Clinical Research
Riverside, California 92503
Contact:
951-374-1190

South Denver Gastroenterology
Englewood, Colorado 80113

K2 Medical Research WINTER GARDEN
Clermont, Florida 34711
Contact:
407-426-9299

K2 Medical Research - Daytona Beach
Daytona Beach, Florida 32114

Care Access - Delray Beach
Delray Beach, Florida 33484
Contact:
401-773-7855

Southwest General Healthcare Center
Fort Myers, Florida 33907
Contact:
239-931-3368

Encore Medical Research
Hollywood, Florida 33024
Contact:
954-400-1725

Nature Coast Clinical Research - Inverness
Inverness, Florida 34452
Contact:
352-341-2100

Encore Borland-Groover Clinical Research
Jacksonville, Florida 32256
Contact:
904-680-0871

Health Awareness
Jupiter, Florida 33458

K2 MEDICAL Research THE VILLAGES
Lady Lake, Florida 32159
Contact:
352-500-5252

Florida Research Institute
Lakewood Rch, Florida 34211
Contact:
941-727-7772

Tampa Bay Medical Research - Largo
Largo, Florida 33777
Contact:
727-724-3316

Evolution Clinical Trials
Miami, Florida 33122-1722
Contact:
786-706-1216

Floridian Clinical Research, LLC
Miami Lakes, Florida 33016-1518
Contact:
305-330-9977

GI PROS Research
Naples, Florida 34102
Contact:
239-571-0899

Charter Research - Orlando
Orlando, Florida 32803

Headlands Research Orlando
Orlando, Florida 32806
Contact:
407-705-3471

Progressive Medical Research
Port Orange, Florida 32127
Contact:
386-304-7070

Covenant Metabolic Specialists - Riverview
Riverview, Florida 33578
Contact:
941-894-2014

Care Access - St. Petersburg
St. Petersburg, Florida 33710
Contact:
877-791-0656

Care Access - Tamarac
Tamarac, Florida 33321
Contact:
877-791-0656

Covenant Metabolic Specialists, LLC
University Park, Florida 34201
Contact:
941-894-2014

Southeast Clinical Research Center
Dalton, Georgia 30720
Contact:
706-913-1779

Gastrointestinal Specialists of Georgia
Marietta, Georgia 30060
Contact:
404-786-3100

Indiana University Health University Hospital
Indianapolis, Indiana 46202
Contact:
317-278-1652

Digestive Research Alliance of Michiana
South Bend, Indiana 46635
Contact:
574-904-9617

Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa 50266
Contact:
515-329-6800

AMR Clinical
El Dorado, Kansas 67042
Contact:
316-600-5127 EXT 301

Cotton O'Neil Digestive Health Center
Topeka, Kansas 66606
Contact:
785-270-4800

Delta Research Partners of Bastrop, LLC
Bastrop, Louisiana 71220
Contact:
318-281-6040

Tandem Clinical Research
Marrero, Louisiana 70072
Contact:
504-934-8424

Care Access - New Iberia
New Iberia, Louisiana 70560
Contact:
813-851-0135

Louisiana Research Center
Shreveport, Louisiana 71105
Contact:
318-525-3227

Delta Research Partners of West Monroe
West Monroe, Louisiana 71291

Lucida Clinical Trials
New Bedford, Massachusetts 02740

Great Lakes Research Institute
Southfield, Michigan 48075
Contact:
248-864-5242

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan 48098
Contact:
248-312-0025

GI Associates - GIA and Endoscopy Center - Flowood
Flowood, Mississippi 39232
Contact:
601-863-0395

Jubilee Clinical Research NV. LLC
Las Vegas, Nevada 89106
Contact:
702-631-5000

Excel Clinical Research, LLC
Las Vegas, Nevada 89109
Contact:
702-680-1500

Clinical Research of Philadelphia
Pennington, New Jersey 08534
Contact:
215-676-6696

IMA Clinical Research Warren
Warren Township, New Jersey 07059

IMA Clinical Research Manhattan
New York, New York 10036

New York Gastroenterology Associates
New York, New York 10075

Care Access - Yonkers
Yonkers, New York 10701

Carteret Medical Group
Morehead City, North Carolina 28557
Contact:
252-499-8623

Akron Gastro Research
Akron, Ohio 44320

CRIOH
Westlake, Ohio 44145
Contact:
440-363-4000

US Digestive Health - Wyomissing
Wyomissing, Pennsylvania 19610
Contact:
610-374-4401

University Gastroenterology
Providence, Rhode Island 02905

Galen Medical Group - Galen Hepatology
Chattanooga, Tennessee 37421
Contact:
423-653-0842

American Research Corporation at Texas Liver Institute
Austin, Texas 78215
Contact:
210-253-3426

IMA Clinical Research Austin
Austin, Texas 78745
Contact:
512-649-0082

American Research Corporation
Austin, Texas 78757
Contact:
210-253-3426

Bellaire Clinical Research
Bellaire, Texas 77401
Contact:
281-844-3160

Headlands Horizons, LLC dba Headlands Research-Brownsville
Brownsville, Texas 78526

Soma Clinical Trials
Denison, Texas 75020
Contact:
469-819-0228

Epic Medical Research - DeSoto
DeSoto, Texas 75115
Contact:
197-277-7695

South Texas Research Institute
Edinburg, Texas 78539
Contact:
956-309-3433

Dallas Research Institute
Farmers Branch, Texas 75234
Contact:
214-347-7577

Care United Research, LLC
Forney, Texas 75126
Contact:
972-564-0044

HRI- Medical Center
Houston, Texas 77004

Care Access - Houston
Houston, Texas 77054
Contact:
877-791-0656

Houston Research Institute
Houston, Texas 77079
Contact:
281-809-3234

Biopharma Informatic, LLC
Houston, Texas 77084
Contact:
281-944-3610

Research Physicians Network, LLC
Houston, Texas 77089
Contact:
281-944-3610

Biopharma Informatic, LLC
McAllen, Texas 78503
Contact:
281-944-3610

Southern Endocrinology Associates
Mesquite, Texas 75149
Contact:
214-693-0904

HRI Pasadena
Pasadena, Texas 77505
Contact:
832-847-1727

Clinical Trials of Texas, LLC dba Flourish Research
San Antonio, Texas 78229
Contact:
210-949-0122

IMA Clinical Research San Antonio
San Antonio, Texas 78229
Contact:
210-692-7157

Consano Clinical Research, LLC
Shavano Park, Texas 78231
Contact:
210-545-4900

GI Alliance - Southlake
Southlake, Texas 76092
Contact:
940-367-2316

Houston Research Institute (HRI) - Sugar Land
Sugar Land, Texas 77478

Texas Valley Clinical Research
Weslaco, Texas 78596
Contact:
956-431-8090

Medrasa Clinical Research
Wylie, Texas 75098
Contact:
469-449-3645

Care Access - Ogden
Ogden, Utah 84403
Contact:
801-614-0010

Advanced Research Institute - Sandy
Sandy City, Utah 84070
Contact:
801-409-2040

Washington Gastroenterology - Bellevue
Bellevue, Washington 98004
Contact:
425-454-4768

CAMC Health Education and Research Institute Inc
Charleston, West Virginia 25304
Contact:
304-388-9944

Isis Clinical Research Center
Guaynabo, Puerto Rico 00968
Contact:
7874045252

Klinical Investigations Group
San Juan, Puerto Rico 00909
Contact:
7879197865

More Details

NCT ID
NCT07165028
Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center