On Wednesday, the stocks of Madrigal Pharmaceuticals Inc MDGL and Sagimet Biosciences Inc SGMT are trading lower.
At the EASL International Liver Congress 2024, Eli Lilly And Co LLY shared an abstract highlighting fibrosis results from a Phase 2 trial of tirzepatide in patients with metabolic dysfunction-associated steatohepatitis (MASH).
Tirzepatide is a key ingredient in popular Mounjaro for diabetes and Zepbound for weight loss.
Other companies working on MASH candidates include 89bio Inc ETNB, Akero Therapeutics Inc AKRO, and Viking Therapeutics Inc VKTX.
The Phase 2 SYNERGY-NASH trial studied three doses (5 mg, 10 mg or 15 mg) of tirzepatide in 190 people. End-of-treatment liver biopsies were available for 157 participants.
The proportion of participants who achieved MASH resolution without worsening of fibrosis was 9.8% for placebo, 43.6% for 5 mg, 55.5% for 10 mg and 62.4% for 15 mg.
Among 155 participants who completed the study on treatment with evaluable biopsies, the primary endpoint of MASH resolution without worsening of fibrosis was achieved by 51.8%, 62.8%, and 73.3% for tirzepatide 5 mg, 10 mg, and 15 mg, respectively, compared with 13.2% for placebo.
The proportion who achieved ≥ 1-stage fibrosis improvement without worsening of MASH was 29.7% for placebo, 54.9% for tirzepatide 5 mg, 51.3% for tirzepatide 10 mg, and 51.0% for tirzepatide 15 mg.
A reduction in nonalcoholic fatty liver disease activity score (NAS) by ≥ 2 points was achieved by 71.7% to 78.3% of participants across the three tirzepatide dose groups and by 36.7% with placebo. Body weight was reduced by up to 17.3% with tirzepatide.
Liver enzymes and fat decreased, and serum and imaging biomarkers of liver inflammation and fibrosis significantly improved in the tirzepatide groups compared to the placebo.
The abstract added that there was a lack of a clear dose relationship in achieving MASH resolution without worsening the fibrosis endpoint.
Larger and longer trials are needed to assess the efficacy and safety of tirzepatide for non-cirrhotic MASH.
Price Action: MDGL shares are down 5.14% at $231.78, and SGMT shares are down 7.22% at $4.66 at the last check on Wednesday.
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