SYNERGY-NASH phase 2 trial

TIRZEPATIDE-STUDY-P098

Loomba et al. (2024), SYNERGY-NASH.

Study design

Record details

Design: Randomized phase 2 trial with 52-week follow-up.
Population or model: Adults with metabolic dysfunction-associated steatohepatitis and liver fibrosis in the protocol-defined population.
Material tested: Lilly-manufactured tirzepatide clinical product.
Comparator: Placebo.

Evidence record

Endpoints

Resolution of metabolic dysfunction-associated steatohepatitis without worsening of fibrosis; fibrosis improvement.

Qualified findings

The trial supports a phase 2 metabolic dysfunction-associated steatohepatitis resolution signal.

Limitations

Fibrosis improvement remains less settled. Larger and longer trials are needed; the 2026 erratum does not change the draft claim.

Reports and sources

P098Human controlled primary (phase 2); PEER REVIEWED

Loomba et al. 2024 SYNERGY-NASH

(2024). DOI: 10.1056/NEJMoa2401943