Major trials

SYNERGY-NASH

The Phase 3 trials that won approval, and the outcome studies that came afterward on cardiovascular, kidney and sleep-apnea endpoints.

Definition

Phase 2 of tirzepatide in adults with biopsy-confirmed MASH and significant fibrosis (Loomba 2024 NEJM, PMID 38856224). The endpoint was histologic — MASH resolution without worsening fibrosis at week 52, which requires a liver biopsy to score. 62% achieved it on 15 mg against 10% on placebo.

SYNERGY-NASH trial deep-dive

GLP Watchdog writes these definitions from FDA labels and peer-reviewed PubMed literature. Not one of them is an AI-generated summary.

Other terms under Major trials

Where the evidence lives