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Eli Lilly announces detailed results from Phase 2 SYNERGY-NASH trial 06:52 LLY Eli Lilly 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, or 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 Congress 2024 and simultaneously published in The New England Journal of Medicine. 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. The overall safety profile of tirzepatide in SYNERGY-NASH was similar to that observed in the previously reported SURMOUNT and SURPASS trials. The most commonly reported adverse events in SYNERGY-NASH were gastrointestinal-related and generally mild to moderate in severity. Lilly is engaged with regulatory authorities on the next steps for tirzepatide for the treatment of MASH.

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