Relationship Between Metabolic and Histological Responses in People With Metabolic Dysfunction- Associated Steatohepatitis With and Without Type 2 Diabetes: Participant-Level Exploratory Analysis of the SYNERGY-NASH Trial With Tirzepatide.

ABSTRACT:

Objective

To explore the relationship between metabolic and histological responses in a phase 2 trial of tirzepatide in metabolic dysfunction-associated steatohepatitis (MASH).

Research design and methods

This is a participant-level post hoc analysis of the 52-week, double-blind, randomized, placebo-controlled SYNERGY-NASH trial (NCT04166773). Participants (n = 190) with MASH and stage 2/3 fibrosis were randomly assigned to receive tirzepatide (5, 10, or 15 mg) or placebo once weekly. The primary end point was MASH resolution without worsening of fibrosis. Secondary end points included fibrosis improvement by at least one stage without worsening of MASH. Metabolic changes were evaluated in responders and nonresponders for histological end points in 154 participants who compl

SUBMITTER: Caussy C 

PROVIDER: S-EPMC12635880 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature