Lilly Announces Positive Phase 2 Results of Tirzepatide in MASH Treatment

On June 8, 2024, Eli Lilly and Company announcedTirzepatideDetailed Results of the Phase 2 Clinical Trial SYNERGY-NASH for the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) Patients.Efficacy evaluation showed that the trial met its primary endpoint, with patients receiving 5 mg, 10 mg, and 15 mg over 52 weeks of treatment.TirzepatideAmong the treated patients, 51.8%, 62.8%, and 73.3% achieved MASH resolution without worsening of liver fibrosis, compared to 13.2% in the placebo group. The trial data was initially presented at this year's European Association for the Study of the Liver (EASL) annual meeting.And simultaneously published in The New England Journal of Medicine (NEJM).

In terms of secondary endpoints, the efficacy evaluation showed that patients receiving 5 mg, 10 mg, and 15 mgTirzepatideAmong the treated patients, 59.1%, 53.3%, and 54.2% of subjects achieved a ≥1-stage improvement in fibrosis without worsening of MASH, compared to 32.8% in the placebo group. Evaluation of additional secondary endpoints showed,TirzepatideAssociated with improvements in body weight, biomarkers of liver injury, and biomarkers of liver fat, inflammation, and fibrosis. Although the design of this Phase 2 study was not intended to proveTirzepatideCan improve fibrosis, but the study results show that all doses ofTirzepatideMay produce clinically significant therapeutic effects.

The overall safety of Tirzepatide in SYNERGY-NASH was similar to the safety observed in the previously reported SURMOUNT and SURPASS trials. The most common adverse events in SYNERGY-NASH were gastrointestinal-related adverse events (nausea, diarrhea, decreased appetite, constipation, and weight loss), generally mild to moderate in severity.

About Eli Lilly and Company

Eli Lilly and Company is a globally leading pharmaceutical company engaged in the research, development, manufacturing, and marketing of medicines, dedicated to improving human health through innovation. Eli Lilly and Company was founded over a century ago by Colonel Eli Lilly in Indianapolis, Indiana, in 1876, with the founder committed to producing high-quality medicines to meet genuine medical needs.