Tirzepatide, the main ingredient for Eli Lilly's Mounjaro and Zepbound, omitted the presence of metabolic dysfunction-associated steatohepatitis in a phase 2 study, the drugmaker said June 8. The trial results could precede another indication for the popular drugs.
Mounjaro, a Type 2 diabetes medication, and Zepbound, a weight loss injection, are part of a booming class of drugs called GLP-1s that include the blockbusters Ozempic and Wegovy.
In a phase 2 trial with 190 participants, Eli Lilly tested tirzepatide in adults with MASH — liver inflammation — with stage 2 or 3 fibrosis. After 52 weeks, 51.8%, 62.8% and 73.3% of people taking 5 milligrams, 10 milligrams and 15 milligrams, respectively, saw an absence of MASH with no worsening of fibrosis on liver histology. The placebo cohort logged a 13.2% MASH absence.
As Eli Lilly chugs ahead on a phase 3 trial, the drugmaker said it is working with regulatory agencies on "the next steps for tirzepatide for the treatment of MASH."
If tirzepatide continues to secure positive results among MASH patients, Mounjaro and Zepbound might see a new FDA approval. The company is already seeking a sleep apnea indication for Mounjaro as other GLP-1s manufacturers march into areas outside weight loss and diabetes, including heart disease, chronic kidney disease and others.