Tirzepatide for Metabolic Dysfunction-Associated Steatohepatitis with Liver Fibrosis
Abstract
This phase 2, multicenter, randomized, placebo-controlled trial evaluated the efficacy and safety of tirzepatide, a dual glucose dependent insulinotropic polypeptide (GIP) and glucagon like peptide 1 (GLP-1) receptor agonist, in patients with metabolic dysfunction-associated steatohepatitis (MASH) and moderate or severe liver fibrosis. Participants received once weekly subcutaneous tirzepatide (5 mg, 10 mg, or 15 mg) or placebo for 52 weeks. The primary endpoint was resolution of MASH without worsening of fibrosis. Results showed significantly higher rates of MASH resolution in tirzepatide groups (44-62%) compared to placebo (10%). Improvements in fibrosis and liver biomarkers were also observed. The safety profile was consistent with previous trials, with gastrointestinal events being the most common adverse effects. Larger and longer trials are needed to confirm these findings.