Clinical research

SYNERGY-NASH: Tirzepatide for MASH with liver fibrosis

Phase 2, dose-finding, multicentre, double-blind, randomised, placebo-controlled, 130 sites in 10 countries. Randomised 1:1:1:1, over 52 weeks. Sponsor: Eli Lilly and Company.

SYNERGY-NASH (NCT04166773) tested tirzepatide, once-weekly subcutaneous at 5 mg, 10 mg or 15 mg against placebo in adults 18-80 with biopsy-confirmed mash, stage f2 or f3 fibrosis, bmi 27-50, with or without type 2 diabetes, nafld activity score of 4 or above.Tirzepatide was superior to placebo for MASH resolution without worsening of fibrosis. Reported resolution rates differ between secondary sources: one gives 51.8%, 62.8% and 73.3% at 5, 10 and 15 mg against 13.2% placebo; another gives 62% at 15 mg against 10% placebo Primary source linked: the source is a citable peer-reviewed / registry record, which we have not independently re-extracted from the full paper in this session.

Study design

Results

Tirzepatide was superior to placebo for MASH resolution without worsening of fibrosis. Reported resolution rates differ between secondary sources: one gives 51.8%, 62.8% and 73.3% at 5, 10 and 15 mg against 13.2% placebo; another gives 62% at 15 mg against 10% placebo

Adverse events & discontinuations

Nausea, diarrhoea, decreased appetite, constipation and weight loss, generally mild to moderate. No new safety signals against the SURMOUNT and SURPASS programmes

Limitations

Phase 2 and dose-finding rather than confirmatory. Fibrosis improvement was less pronounced than MASH resolution at 52 weeks. No head-to-head against semaglutide for liver endpoints. Secondary sources report materially different resolution figures, so we have not charted a single number.

Practical interpretation

This is one trial, reported by Eli Lilly and Company, read directly against the registry and publication linked below — GLP Ranked has not re-run the statistics or obtained the patient-level data. Results describe group averages under trial conditions and may not describe any individual's outcome, including with a compounded, non-FDA-approved version of a similar active ingredient. Always check the primary source before citing a specific number.