Registry update — unassessed
A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Pharmacologic Agents in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Who Are at Increased Risk of Developing Major Adverse Liver Outcomes
Trial registry update: RECRUITING. No results reported in the supplied registry record.
RCTN=4,500Notable significance
What this changes
The finding has not established an approved change to our evidence assessment.
Source date: Sep 22, 2026 · Discovered: Sep 23, 2026 · Assessed: — · Research update
What it does not prove
- This is a protocol paper describing a planned study; no efficacy results have yet been reported
- The effect sizes and clinical significance of any benefit or harm from these interventions remain unknown until outcome data are published
- Whether benefits in liver-specific outcomes translate to improvements in mortality, transplantation rates, or quality of life has not been established
Extracted from supplied source material; model confidence is not a measured probability of correctness.
Study details
- Design
- Rct
- Sample size
- 4,500
- Duration
- 224 months
- Population
- Adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at increased risk of developing major adverse liver outcomes (MALO), identified by non-invasive tests (NITs).
- Primary outcome
- Prevention of major adverse liver outcomes (MALO) in people with high-risk MASLD
- Effect size
- —
- Significance
- Not reported
- Journal
- Eli Lilly and Company
- Published
- Sep 22, 2026
Funding: Eli Lilly and Company
Sources
Primary source
- Eli Lilly and Company ↗Clinical trial
Recorded source passages
Abstract or registry material supplied for assessment; source version 1. This is not a claim of full-text review.
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.
Assessment history
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