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N1T-MC-MALO: 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 (SYNERGY-Outcomes); N1T-MC-TZ01 Tirzepatide in participants with high-risk MASLD; N1T-MC-RT01 Retatrutide in participants with high-risk MASLD

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522674-36-00
Enrollment
170
Registered
2026-01-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease

Brief summary

Time to First Occurrence of Any Component of the Composite Endpoint for Major Adverse Liver Outcomes (MALO), Composite endpoint comprised of progression to cirrhosis, development of large esophageal varices, gastric varices or development of varices needing treatment, development of ascites, development of hepatic encephalopathy, evidence of active or recent variceal hemorrhage, increase in model for end-stage liver disease (MELD) from ≤12 to ≥15, liver transplantation, all-cause mortality, [Time Frame: Baseline up to Study Completion (about 224 weeks)]

Interventions

DRUGTIRZEPATIDE
DRUGRetatrutide
DRUGPlacebo to match LY

Sponsors

Eli Lilly & Co.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Time to First Occurrence of Any Component of the Composite Endpoint for Major Adverse Liver Outcomes (MALO), Composite endpoint comprised of progression to cirrhosis, development of large esophageal varices, gastric varices or development of varices needing treatment, development of ascites, development of hepatic encephalopathy, evidence of active or recent variceal hemorrhage, increase in model for end-stage liver disease (MELD) from ≤12 to ≥15, liver transplantation, all-cause mortality, [Time Frame: Baseline up to Study Completion (about 224 weeks)]—

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026