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

StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Study sites revised (563)
  2. Eligibility criteria expanded, about 9 words
    • Study sites revised (563)
  3. Study sites: 565 to 563v24
  4. Study sites: 564 to 565v23
  5. Study sites: 563 to 564v22
Show 20 earlier versionsHide 20 earlier versions
  1. Study sites: 561 to 563v21
  2. Study sites: 562 to 561v20
  3. Study sites: 561 to 562v19
  4. Study sites: 562 to 561v18
  5. Study sites revised (562)v17
  6. Study sites: 561 to 562v16
  7. Study sites revised (561)v15
  8. Study sites: 559 to 561v14
  9. Site details revised at 11 of 559 sitesv13
  10. Study sites: 557 to 559v12
  11. Study sites revised (557)v11
  12. Study sites: 555 to 557v10
  13. Study sites: 554 to 555v9
  14. Study sites: 548 to 554v8
  15. Study sites: 542 to 548v7
  16. Study sites: 526 to 542v6
  17. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 491 to 526
    • Start date changed from estimate of Dec 2025 to Oct 15, 2025
    v5
  18. Study sites: 459 to 491v4
  19. Study sites: 403 to 459v3
  20. Study sites: 211 to 403v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Eli Lilly
366 trials monitored
See 16 trials at risk
NASH / MASH
694 trials monitored
See 25 trials at risk
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.
Trial Details
NCT Number NCT07165028
Lead Sponsor Eli Lilly and Company
Conditions
(from sponsor)		 Metabolic Dysfunction-Associated Steatotic Liver Disease
Related terms Fatty Liver, Non-alcoholic Fatty Liver Disease
Enrollment 4,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov