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

Recruiting · Phase 3 · NCT07165028

Conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease

At a glance

Research payments reported, 2025
$233,324
U.S. investigators named
92
Sites paid
64
Planned or actual enrollment
4,500

About the trial

Sponsor
Eli Lilly and Company
Tested
Tirzepatide (drug), Retatrutide (drug), Placebo (drug)
Dates
Started 2025-10-15; completion 2032-08
Results posted
Not yet

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 moni…

From ClinicalTrials.gov, last updated 2026-10-08. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Eli Lilly and Company reported $233,324 in research payments for this study in 2025 (217 payments).

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

  • $47,179
  • Care Access Research LLC $16,177
  • Ima Evaluations LLC DBA Ima Clinical Research $9,244
  • Alliance for Multispecialty Research Lls $7,406
  • Houston Research Institute LLC $6,944
  • K2 Medical Research LLC $6,010
  • Institute for Liver Health LLC $6,010
  • Epic Medical Research $4,622
  • Washington Gastroenterology PLLC $4,622
  • Capital Clinical Research Center PLLC $4,622
  • Biopharma Informatic Inc $4,622
  • American Research Corp Inc $4,160
  • Ark Clinical Research LLC $3,699
  • Advanced Research Institute $3,245
  • Texas Digestive Disease Consultants $3,245
  • Delta Research PArtners LLC $2,783
  • Florida Digestive Health Specialists LLP $2,537
  • Consano Clinical Research LLC $2,311
  • Headlands Horizons LLC $2,311
  • Medrasa Clinical Research LLC $2,311
  • Floridian Clinical Research LLC $2,311
  • Clinical Trial Source LLC $2,311
  • Cahaba Research $2,311
  • Eximia Research - Nc, LLC $2,311
  • Tampa Bay Medical Research Inc $2,311
  • Carteret Medical Group LLC $2,311
  • Galen Medical Group PC $2,311
  • Iowa Diabetes and Endocrinology Rsrch Cntr $2,311
  • Southern Endocrinology Associates PA $2,311
  • Southeastern Clinical Research Institute LLC $2,311
  • Soma Clinical Trials LLC $2,311
  • University Gastroenterology LLC $2,311
  • Evolution Clinical Trials Inc $2,311
  • Care United Research $2,311
  • New York University $2,311
  • Dermatology Cente for Skin Health $2,311
  • Clinical Trials of Texas Inc $2,311
  • Progressive Medical Concepts LLC $2,311
  • Lucida Clinical Trials $2,311
  • Arcturus Healthcare PLC, Troy Internal $2,311
  • Great Lakes Research Institute LLC $2,311
  • Nature Coast Clinical Research $2,311
  • Cotton Oneil Msd of Stormont Vail Healthcare $1,849
  • Tandem Clinical Research,llc $1,849
  • Biopharma Informatic Inc Research Center $1,849
  • Sky Clinical Research Network Group $1,849
  • Sfct A Member of the Alliance Inc $1,849
  • Charter Research LLC $1,849
  • Ventura Clinical Trials $1,849
  • Memorial Research Medical Clinic $1,849
  • Monroe Biomedical Research $1,849
  • New York Gastroenterology Associates $1,849
  • Om Research LLC $1,849
  • Medical Research Ctr of Ct LLC $1,849
  • Oklahoma Medical Research Foundation $1,849
  • Texas Valley Clinical Research LLC $1,849
  • San Fernando Valley Health Institute LLC $1,849
  • Indiana University $1,849
  • Bellaire Dermatology Associates $1,849
  • Harborview Medical Center University of Washington $1,849
  • Clinical Research of Philadelphia LLC $1,396
  • Intend Research LLC $934
  • Research Foundation of State Univ of Ny $934
  • Artemis Headlands LLC $934
  • Louisiana Research Center, LLC $934

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.