Eli Lilly’s once-weekly GIP/GLP-1 receptor agonist tirzepatide has shown promise as a treatment for the fatty liver disease metabolic dysfunction-associated steatohepatitis (MASH).
Currently the second most common contributor to liver transplantation in the US, MASH is expected to affect more than 19 million adults in the US by 2039.
Tirzepatide, administered as a subcutaneous injection, already holds approvals for weight management and to treat type 2 diabetes.
Detailed results from the mid-stage SYNERGY-NASH trial, which has been evaluating the investigational use of the drug in 190 adults with biopsy-proven MASH and stage 2 or 3 fibrosis, were presented at this year’s European Association for the Study of the Liver Congress.
The efficacy estimand showed that 51.8%, 62.8% and 73.3% of patients taking 5mg, 10mg and 15mg doses of tirzepatide, respectively, achieved an absence of MASH with no worsening of fibrosis on liver histology compared to 13.2% of those in the placebo cohort at 52 weeks, meeting the study’s primary endpoint.
For the trial’s secondary endpoint, 59.1%, 53.3% and 54.2% of patients in the 5mg, 10mg and 15mg tirzepatide groups, respectively, achieved a one-stage or greater fibrosis improvement without worsening of MASH compared to 32.8% of those on placebo.
Tirzepatide was also associated with improvements in additional secondary endpoints, including body weight and blood markers, and the safety profile of the drug was similar to that observed in the previously-reported SURMOUNT and SURPASS trials.
Jeff Emmick, senior vice president, product development at Lilly, said the company was “very pleased” with the degree of MASH resolution observed in SYNERGY-NASH and was “encouraged” by the improvement of fibrosis observed.
“Based on the study results, we believe tirzepatide may have the potential to help people living with this disease,” he said.
Lilly outlined that it is “engaged with regulatory authorities on the next steps for tirzepatide for the treatment of MASH”.
The results come less than a month after Lilly shared positive topline results from two late-stage studies evaluating its investigational once-weekly insulin efsitora (efsitora alfa) in adults with type 2 diabetes.