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Human controlled primary / regulatoryStrong for measured apnea-hypopnea index endpointCompleted; peer reviewed; label context verified

SURMOUNT-OSA obstructive sleep apnea trials

TIRZEPATIDE-STUDY-P103

Malhotra et al. (2024), SURMOUNT-OSA.

Study design

Record details

Design: Randomized, double-blind, placebo-controlled trials.
Population or model: Adults with obesity and moderate-to-severe obstructive sleep apnea in the protocol-defined populations.
Material tested: Lilly-manufactured tirzepatide clinical product and the exact Zepbound label context.
Comparator: Placebo.

Evidence record

Endpoints, findings, and limitations

Endpoints

Change in apnea-hypopnea index and protocol-defined secondary outcomes.

Qualified findings

The program supports apnea-hypopnea index reduction and the Zepbound obstructive sleep apnea indication for the exact labeled population.

Limitations

The evidence does not establish that the sleep-apnea effect is independent of weight change. The 2024 erratum corrected placebo severe-hypoglycemia counts, not the apnea-hypopnea index claim.

Reports and sources

Reference ledger

P103Human controlled primary; PEER REVIEWED, randomised, placebo-controlled

Malhotra et al. 2024 SURMOUNT-OSA

(2024). DOI: 10.1056/NEJMoa2404881
P138Regulatory record

Zepbound USPI rev. 02/2026

(2026)
P140Regulatory record

Zepbound DailyMed label rev. 08/2026

(2026)
P153Regulatory record (describing human controlled primary evidence)

FDA OSA approval announcement