Tirzepatide Helps Resolve MASH in Patients with Fibrosis

On Thursday, June 13, 2024, a significant advancement was reported for patients suffering from metabolic dysfunction-associated steatohepatitis (MASH) with moderate-to-severe fibrosis. A recent study, featured online on June 8 in the New England Journal of Medicine, highlighted the efficacy of tirzepatide compared to a placebo for treating MASH. This publication aligns with the annual congress of the European Association for the Study of the Liver held from June 5 to 8 in Milan.

The research was led by Rohit Loomba, M.D., from the University of California at San Diego, along with his team. They conducted a phase 2, dose-finding, placebo-controlled trial focusing on participants with biopsy-confirmed MASH and stage F2 or F3 fibrosis. The study participants were randomly divided to receive either a weekly subcutaneous dose of tirzepatide (5 mg, 10 mg, or 15 mg) or a placebo for 52 weeks.

Out of the 190 participants initially randomized, 157 had evaluable liver-biopsy results at the end of the 52-week period. The missing data were accounted for through imputation. The findings revealed that the percentage of participants achieving MASH resolution without worsening fibrosis was 10 percent in the placebo group, compared to 44 percent, 56 percent, and 62 percent in the 5 mg, 10 mg, and 15 mg tirzepatide groups, respectively. Additionally, the proportion of patients showing an improvement of at least one stage of fibrosis without worsening MASH was 30 percent in the placebo group, and 55 percent, 51 percent, and 51 percent in the 5 mg, 10 mg, and 15 mg tirzepatide groups, respectively.

The most frequently reported adverse events in the tirzepatide groups were gastrointestinal issues, which were primarily mild to moderate in severity.

Despite these promising results, the authors noted that larger and longer trials are essential to further validate the efficacy and safety of tirzepatide for treating MASH with liver fibrosis. Moreover, they aim to determine if tirzepatide can reduce the risk of major adverse liver outcomes.

It is important to mention that several authors of this study have disclosed connections to biopharmaceutical companies, including Eli Lilly, the manufacturer of tirzepatide and the funder of this study. This information is crucial to ensure transparency and maintain the integrity of the research findings.