Eli Lilly Receives FDA Approval for Zepbound in Nonalcoholic Steatohepatitis

Eli Lilly and Company today announced that the FDA has approved Zepbound (tirzepatide) for the treatment of adults with nonalcoholic steatohepatitis (NASH) with moderate-to-advanced liver fibrosis (stage F2 or F3). The approval was based on results from the Phase 3 SYNERGY-NASH trial, which demonstrated a statistically significant improvement in NASH resolution without worsening of fibrosis compared to placebo. The NASH resolution rate was 52.9% for Zepbound versus 16.1% for placebo. This approval makes Zepbound the first GLP-1/GIP receptor agonist approved for NASH, expanding its therapeutic applications.