Lilly's Tirzepatide Shows Promising Phase II NASH Results, Eyes Expansion

Eli Lilly has unveiled promising new data from its Phase II SYNERGY-NASH trial, highlighting the potential of its GLP-1/GIP dual receptor agonist in treating nonalcoholic steatohepatitis (NASH). The trial revealed significant improvements in liver fibrosis among patients administered tirzepatide.

After 52 weeks, 54.9% of patients receiving a 5-mg dose of tirzepatide showed at least a one-stage improvement in liver fibrosis without any worsening of the disease. Similar results were observed in groups receiving 10-mg and 15-mg doses, with 51.3% and 51% of patients, respectively, meeting the same endpoint. In contrast, only 29.7% of patients in the placebo group exhibited comparable improvements.

Tirzepatide's efficacy was statistically validated, showing a significant treatment effect over placebo with p-values less than 0.05 for all doses. Additionally, the drug facilitated notable weight loss, with patients losing up to 17.3% of their body weight. The treatment also led to reductions in liver enzymes, liver fat, and biomarkers related to fibrosis and liver inflammation.

These findings were presented at the 2024 Congress of the European Association for the Study of the Liver (EASL24) in Milan, Italy. The SYNERGY-NASH trial is a randomized, double-blind, placebo-controlled study aimed at evaluating tirzepatide's safety and efficacy in patients with histologically confirmed NASH featuring stage two or three fibrosis.

Earlier, Lilly had shared preliminary results indicating that up to 74% of tirzepatide-treated patients achieved NASH resolution without worsening fibrosis, compared to approximately 13% of those on placebo. The latest EASL24 data offer a more comprehensive view of the trial's primary endpoint. In the 5-mg dose group, 43.6% of patients attained NASH resolution without worsening fibrosis. The percentages increased to 55.5% and 62.4% in the 10-mg and 15-mg dose groups, respectively, while only 9.8% of the placebo group reached this endpoint.

Tirzepatide, a protein-based therapy, works by activating the GLP-1 receptor, which triggers insulin secretion in response to blood sugar levels, and the GIP receptor, which helps regulate appetite. This dual mechanism aids in significant weight loss, making tirzepatide a potentially effective treatment for NASH as well.

The FDA initially approved tirzepatide under the brand name Mounjaro in May 2022 for treating type 2 diabetes. The drug received another approval as Zepbound in November 2023 for weight management. Since its market introduction, tirzepatide has been a major revenue driver for Eli Lilly, generating over $1.8 billion in the first quarter of 2024 as Mounjaro and more than $500 million as Zepbound within the same period.

The new data from the SYNERGY-NASH trial could pave the way for a label expansion of tirzepatide to include NASH treatment, potentially boosting its market performance further.

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