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Human controlled primaryStrong for measured body-weight endpointsCompleted; peer reviewed

SURMOUNT-1 obesity trial

TIRZEPATIDE-STUDY-P051

Jastreboff et al. (2022), SURMOUNT-1.

Study design

Record details

Design: Randomized, double-blind, placebo-controlled phase 3 trial.
Population or model: Adults with obesity or overweight without diabetes in the protocol-defined population.
Material tested: Lilly-manufactured tirzepatide clinical product.
Comparator: Placebo.

Evidence record

Endpoints

Percentage change in body weight and protocol-defined weight-reduction thresholds through week 72.

Qualified findings

SURMOUNT-1 supports large average percentage changes in body weight under the trial conditions.

Limitations

Interpretation depends on the population, week-72 window, and prespecified handling of treatment discontinuation and missing measurements.

Reports and sources

P051Human controlled primary (phase 3, double-blind, placebo-controlled), PEER REVIEWED

Jastreboff et al. 2022 SURMOUNT-1

(2022). DOI: 10.1056/NEJMoa2206038