SURMOUNT-5 direct active-comparator trial

TIRZEPATIDE-STUDY-P064

Aronne et al. (2025), SURMOUNT-5.

Study design

Record details

Design: Randomized, open-label, active-controlled phase 3b trial.
Population or model: Adults with obesity in the protocol-defined population.
Material tested: Lilly-manufactured tirzepatide clinical product.
Comparator: Semaglutide.

Evidence record

Endpoints, findings, and limitations

Endpoints

Percentage change in body weight and change in waist circumference.

Qualified findings

The direct comparison favored tirzepatide for the verified body-weight and waist-circumference endpoints under trial conditions.

Limitations

Open-label; the PubMed abstract and an institutional-repository copy were reviewed, but the publisher version and supplement were not. Do not expand beyond the verified endpoints.

Reports and sources

Reference ledger

P064Human controlled primary (phase 3b, open-label, active-controlled); PEER REVIEWED

Aronne et al. 2025 SURMOUNT-5

(2025). DOI: 10.1056/NEJMoa2416394