Clinical research

SURMOUNT trial program

Established tirzepatide for chronic weight management and produced first FDA-approved drug for OSA.

Established tirzepatide for chronic weight management and produced first FDA-approved drug for OSA.

SURMOUNT-1 — foundational

Jastreboff et al. (NEJM 2022): 2,539 adults with obesity, no diabetes. Weight loss at 72 weeks: 15.0% (5 mg), 19.5% (10 mg), 20.9% (15 mg) vs 3.1% (placebo). 57% at 15 mg lost ≥20%. Basis for Zepbound approval (Nov 2023).

SURMOUNT-OSA — sleep apnea

Malhotra et al. (NEJM 2024): adults with moderate-severe OSA + obesity. AHI reduction −25.3 events/hr (tirz) vs −5.3 (placebo) in PAP-naive cohort at 52 weeks. ~50% achieved OSA disease remission. Basis for December 2024 FDA approval — first drug ever FDA-approved for OSA.

SURPASS-3 — head-to-head with insulin

Heise et al. (Lancet 2021): tirzepatide superior to titrated insulin degludec in T2D on A1c and weight, with lower hypoglycemia.

SURMOUNT-MMO — CV outcomes

Reads out 2026. If positive on MACE, FDA cardiovascular indication for Zepbound expected.

Implications

RA
Dr. Richard Allen, M.D. Endocrinology Reviewer · View bio →
Reviewed and fact-checked on May 20, 2026.