Randomised clinical trial: Design of the SYNERGY-NASH phase 2b trial to evaluate tirzepatide as a treatment for metabolic dysfunction-associated steatohepatitis and modification of screening strategy to reduce screen failures

What Was Tested

This randomized controlled trial paper looks at Tirzepatide.

To describe the design of a trial investigating tirzepatide treatment of MASH and to examine the effect of new inclusion criteria incorporating the use of the FibroScan-AST (FAST) score on the proportion of patients meeting histological criteria.

Who Took Part

By PubMed's age tags, the people studied were adults and middle-aged adults, both men and women.

SYNERGY-NASH is a Phase 2b, multicentre, randomised, double-blinded, placebo-controlled trial in patients with biopsy-confirmed MASH, F2-F3 fibrosis and NAFLD Activity Score ≥4.

How the Study Was Run

The researchers set it up as a randomized, double-blind, placebo-controlled and multicenter study.

Random assignment meant chance, not the researchers, decided who got Tirzepatide and who got the comparison, which limits bias.

As a double-blind Tirzepatide study, the assignments were hidden from both participants and investigators until the end.

A placebo (an inactive look-alike) gave the Tirzepatide group a baseline to be compared against.

Running at several centres spread the Tirzepatide study over different clinics and patient groups.

What Was Measured

PubMed files the paper under topics including Non-alcoholic Fatty Liver Disease, Biopsy, Liver and Patient Selection.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Tirzepatide.

The abstract goes on to report its results in about 4 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2024 (Alimentary pharmacology & therapeutics), a journal based in England.

More context: the Tirzepatide compound page, all human trials.