Eli Lilly shares results for tirzepatide for MASH resolution

Betsy Goodfellow | June 10, 2024 | News story | Research and Development |  Eli Lilly, Hepatology, MASH, clinical trial, liver 

Eli Lilly has announced results from the phase 2 SYNERGY-NASH study which assessed 190 patients, with or without type 2 diabetes, evaluating the use of tirzepatide in adults with biopsy-proven metabolic dysfunction-associated steatohepatitis (MASH) with stage 2 or 3 fibrosis.

According to the press release, ‘the efficacy estimand showed 51.8%, 62.8% and 73.3% of participants taking 5mg, 10mg and 15mg, respectively, achieved an absence of MASH with no worsening of fibrosis on liver histology, compared to only 13.2% of participants on placebo at 52 weeks of treatment, meeting the study’s primary endpoint’.

Full data was presented at the European Association for the Study of the Liver (EASL) Congress 2024, as well as published in The New England Journal of Medicine (NEJM).  

The company has also shared data around the secondary endpoint of 1-stage or greater fibrosis improvement without worsening of MASH, with 59.1%, 53.3% and 54.25 of patients on a 5mg, 10mg and 15mg dose, respectively, compared to 32.8% of patients on placebo.

The data also showed improvements in body weight, blood markers of liver injury and biomarkers of liver fat, inflammation and fibrosis, for those taking tirzepatide.

Jeff Emmick MD PhD, senior vice president of product development at Eli Lilly, commented: “Lilly is very pleased with the degree of MASH resolution observed in the SYNERGY-NASH study, and we are encouraged by the improvement of fibrosis observed. MASH is expected to impact more than 19 million adults in the US by 2039 and based on the study results, we believe tirzepatide may have the potential to help people living with this disease.”

Betsy Goodfellow