Lilly's Tirzepatide Reduces Liver Fibrosis in Phase II MASH Study

Eli Lilly has unveiled promising findings from its Phase II SYNERGY-NASH study, which evaluated the efficacy of tirzepatide, a leading diabetes and weight-loss medication, in treating metabolic dysfunction-associated steatohepatitis (MASH). The data, presented at the 2024 Congress of the European Association for the Study of the Liver and published in The New England Journal of Medicine, showcase significant advancements in MASH treatment.

At the 52-week mark, 51.8% of patients administered a 5-mg dose of tirzepatide experienced a resolution of MASH without fibrosis worsening. This success rate rose to 62.8% and 73.3% for those on 10-mg and 15-mg doses respectively, compared to just 13.2% in the placebo group. Secondary endpoints also revealed that nearly 60% of patients on the 5-mg dose achieved at least a one-stage improvement in fibrosis without MASH worsening, with similar results in the higher dose groups. This was in stark contrast to the 32.8% improvement seen in the placebo group.

Despite these encouraging outcomes, Eli Lilly clarified that the SYNERGY-NASH trial was not explicitly designed to demonstrate that tirzepatide improves fibrosis. Nevertheless, the study's results suggest a potentially meaningful clinical impact across all dosage levels of tirzepatide. The treatment also led to significant improvements in body weight, liver injury markers, and biomarkers related to fibrosis, inflammation, and liver fat.

Jeff Emmick, senior vice president of product development at Eli Lilly, expressed satisfaction with the study's results, highlighting the significant resolution of MASH and improvements in fibrosis. He suggested that tirzepatide could offer substantial benefits to individuals suffering from this condition. 

Tirzepatide functions as a dual agonist of the GLP-1 and GIP receptors, facilitating insulin release in response to blood sugar levels and reducing appetite to promote weight loss. This mechanism makes it an effective tool in addressing MASH symptoms. Originally approved by the FDA in May 2022 under the brand name Mounjaro for type 2 diabetes, tirzepatide has emerged as a top-selling product for Eli Lilly, generating over $1.8 billion in the first quarter of 2024 and more than $5.1 billion in 2023.

Additionally, the FDA approved tirzepatide in November 2023 for chronic weight management under the brand name Zepbound. In its first commercial quarter, Zepbound generated over $500 million, underscoring its robust market performance in obesity treatment. The latest findings position Zepbound for a potential new indication in MASH treatment. According to Eli Lilly's announcement, the company is actively engaging with regulatory authorities to determine the next steps for tirzepatide in this context.

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