Eli Lilly’s tirzepatide shows promise in fatty liver disease

Eli Lilly’s once-weekly GIP/GLP-1 receptor agonist tirzepatide has demonstrated significant promise in treating metabolic dysfunction-associated steatohepatitis (MASH), a form of fatty liver disease. MASH is currently the second leading cause of liver transplantation in the United States and is projected to impact more than 19 million adults in the country by 2039.

Tirzepatide, which is administered as a subcutaneous injection, already has approvals for weight management and the treatment of type 2 diabetes. Recently, detailed findings from the SYNERGY-NASH trial, a mid-stage study assessing the drug's effectiveness in treating MASH, were unveiled at the European Association for the Study of the Liver Congress. This trial involved 190 adults with biopsy-confirmed MASH and stage 2 or 3 fibrosis.

The efficacy estimands from the trial revealed notable results. Specifically, 51.8%, 62.8%, and 73.3% of patients taking 5 mg, 10 mg, and 15 mg doses of tirzepatide, respectively, achieved an absence of MASH without worsening liver fibrosis at week 52. In contrast, only 13.2% of those in the placebo group reached this outcome, satisfying the study's primary endpoint.

For the secondary endpoint of the trial, the data showed that 59.1%, 53.3%, and 54.2% of patients in the 5 mg, 10 mg, and 15 mg tirzepatide groups, respectively, experienced at least a one-stage improvement in fibrosis without worsening MASH. Comparatively, 32.8% of patients on placebo achieved this measure. Furthermore, tirzepatide contributed to improvements in additional secondary endpoints such as body weight reduction and favorable changes in blood markers. The safety profile of tirzepatide in this trial was consistent with previous findings from the SURMOUNT and SURPASS trials.

Jeff Emmick, senior vice president of product development at Lilly, expressed satisfaction with the degree of MASH resolution observed in the SYNERGY-NASH trial and optimism about the fibrosis improvement outcomes. "Based on the study results, we believe tirzepatide may have the potential to help people living with this disease," Emmick stated.

Lilly has indicated that it is actively engaging with regulatory authorities to determine the next steps for tirzepatide's use in treating MASH. This promising development follows closely on the heels of positive topline results from two late-stage studies evaluating Lilly's investigational once-weekly insulin efsitora (efsitora alfa) in adults with type 2 diabetes, disclosed less than a month earlier.

In summary, tirzepatide shows considerable potential as a treatment for MASH, offering new hope for millions of individuals potentially affected by the condition in the coming years. The ongoing regulatory discussions and recent trial successes mark a significant step forward in addressing this growing health concern.