Try our mobile app
SYNERGY-NASH results were presented at the European Association for the Study of the Liver Congress 2024 and simultaneously published in The New England Journal of Medicine
INDIANAPOLIS, June 8, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced detailed results from SYNERGY-NASH, a phase 2 study of 190 patients, with or without type 2 diabetes, to evaluate the investigational use of tirzepatide in adults with biopsy-proven metabolic dysfunction-associated steatohepatitis (MASH) with stage 2 or 3 fibrosis. The efficacy estimandi showed 51.8%, 62.8% and 73.3% of participants taking 5 mg, 10 mg and 15 mg, respectively, achieved an absence of MASH with no worsening of fibrosis on liver histology compared to 13.2% of participants on placebo at 52 weeks of treatment, meeting the study's primary endpoint. The data were presented at the European Association for the Study of the Liver (EASL) Congress 2024 and simultaneously published in The New England Journal of Medicine (NEJM).
In a secondary endpoint, the efficacy estimand showed 59.1%, 53.3% and 54.2% of participants taking 5 mg, 10 mg and 15 mg, respectively, achieved a 1-stage or greater fibrosis improvement without worsening of MASH compared to 32.8% of participants on placebo. Evaluation of additional secondary endpoints showed tirzepatide was associated with improvements in body weight, blood markers of liver injury, and biomarkers of liver fat, inflammation and fibrosis. While the phase 2 study was not designed to prove that tirzepatide improves fibrosis, the study results showed the potential for a clinically meaningful treatment effect across all doses.
"MASH is the second most common contributor to liver transplantation in the U.S., highlighting the need for novel therapies1," said Rohit Loomba, MD, MHSc, chief of the division of gastroenterology and hepatology at University of California San Diego School of Medicine. "The study is significant, given the urgent need for treatment options that are capable of slowing the progression of the disease and potentially reducing serious health complications."
Results of the treatment-regimen estimandii analysis (below) were consistent with those observed with the efficacy estimand:
Tirzepatide 5 mg | Tirzepatide 10 mg | Tirzepatide 15 mg | Placebo | |
Primary Endpoint | ||||
MASH resolution without worsening of fibrosis (defined as no increase in fibrosis stage) at week 52 | 43.6 %(p
| |||
