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Eli Lilly and Co (NYSE:LLY) shared detailed results from the SYNERGY-NASH phase 2 study on Saturday.
This trial involved 190 patients, both with and without type 2 diabetes, evaluating tirzepatide in adults with biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH) and stage 2 or 3 fibrosis.
The study’s primary endpoint was met, with 51.8%, 62.8%, and 73.3% of participants taking 5 mg, 10 mg, and 15 mg doses, respectively, achieving MASH resolution without fibrosis worsening compared to 13.2% on placebo at 52 weeks.
Presented at the European Association for the Study of the Liver (EASL) Congress 2024 and published in The New England Journal of Medicine, the data also showed secondary endpoint results.
In a secondary endpoint, participants taking 5 mg, 10 mg, and 15 mg doses saw fibrosis improvement without MASH worsening at rates of 59.1%, 53.3%, and 54.2%, respectively, compared to 32.8% on placebo.
Tirzepatide also improved body weight, liver injury markers, and liver fat, inflammation, and fibrosis biomarkers.
The safety profile of tirzepatide in SYNERGY-NASH was consistent with previous trials, with common side effects including gastrointestinal issues.
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Jeff Emmick, senior vice president, product development, Lilly, “MASH is expected to impact more than 19 million adults in the U.S. by 20392 and based on the study results, we believe tirzepatide may have the potential to help people living with this disease.”
The SYNERGY-NASH study was a multicenter, double-blind, placebo-controlled phase 2 trial assessing tirzepatide’s efficacy and safety at various doses in adults with MASH and stage 2 or 3 fibrosis.
Tirzepatide is a once-weekly GIP and GLP-1 receptor agonist. It helps regulate appetite and fat utilization by activating the body’s GIP and GLP-1 receptors.
Approved by the FDA as Mounjaro for type 2 diabetes in May 2022 and as Zepbound for obesity in November 2023, tirzepatide is under investigation for several other conditions, including metabolic dysfunction-associated steatohepatitis. Both Mounjaro and Zepbound should be used as an adjunct to diet and exercise.
Price Action: LLY shares are trading higher by 0.74% at $856.25 in premarket at the last check Monday.
Disclaimar: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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