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

NCT07165028 on ClinicalTrials.gov · last registry update 2026-10-08

An unusually large phase 3: 4,500 participants, more than double the 424 typical for the stage. Due to report August 2030, alongside 5 other tracked readouts that quarter. Primary outcome, as filed: Time to First Occurrence of Any Component of the Composite Endpoint for Major Adverse Liver Outcomes (MALO). Sponsors move these dates routinely; any movement since this site started watching is listed below. tirzepatide is approved in the US, but not for mash nafld — a registration here is not an approval, and most drugs tested in a new condition never get one for it.

Status: RECRUITING
Phase: P3
Drug: tirzepatide
Mounjaro, Zepbound
Sponsor: Eli Lilly and Company
Sponsor type: Industry
Enrollment: 4,500
Started: 2025-10-15
Primary completion: 2030-08 estimated

Observed history

No changes recorded since monitoring began on 2026-08-21. This record has held steady. If a reporting date moves, a status changes or enrollment is resized, it will appear here with the previous value alongside the new one.

Primary outcome

Time to First Occurrence of Any Component of the Composite Endpoint for Major Adverse Liver Outcomes (MALO)

Conditions studied

Metabolic Dysfunction-Associated Steatotic Liver Disease

Every field above is taken directly from the registry record. See all detected changes across the class, or the tirzepatide page for this molecule’s full trial and approval history.