The SURMOUNT trial program is the pivotal evidence base for tirzepatide as a chronic weight-management medication.
The SURMOUNT clinical program supports tirzepatide's FDA approval for chronic weight management (Zepbound, November 2023) and for moderate-to-severe obstructive sleep apnea in obesity (December 2024). SURMOUNT-1 produced the highest mean weight loss reported in a large phase 3 obesity trial of any approved or investigational anti-obesity medication at the time of its publication.
Tirzepatide vs placebo in 2,539 adults with obesity or overweight with at least one weight-related complication, without diabetes. Published in New England Journal of Medicine, 2022. At 72 weeks, mean body weight reductions on tirzepatide 5 mg, 10 mg, and 15 mg were 15.0%, 19.5%, and 20.9% compared with 3.1% on placebo. The proportion of participants achieving ≥5% weight loss was 85% (5 mg), 89% (10 mg), and 91% (15 mg), versus 35% on placebo. SURMOUNT-1 was the pivotal trial supporting Zepbound's November 2023 FDA approval.
Tirzepatide vs placebo in 938 adults with obesity and type 2 diabetes. Published in The Lancet, 2023. At 72 weeks, mean body weight reductions on tirzepatide 10 mg and 15 mg were 13.4% and 15.7% compared with 3.3% on placebo. The trial established efficacy in the type 2 diabetes population, which typically shows blunted weight loss compared with non-diabetic populations on all weight-management therapies.
Tirzepatide vs placebo after a 12-week intensive lifestyle intervention. Demonstrated that medication produced substantial additional weight loss beyond intensive lifestyle alone. Published in Nature Medicine, 2023.
Adults completed 36 weeks of open-label tirzepatide treatment, then were randomized to continue tirzepatide or switch to placebo for an additional 52 weeks. Published in JAMA, 2024. Continued tirzepatide group: additional weight loss; placebo-switch group: substantial regain. The trial supports clinical positioning of tirzepatide as long-term therapy, with weight regain expected upon discontinuation — analogous to other chronic disease therapies.
Tirzepatide vs placebo in adults with moderate-to-severe obstructive sleep apnea and obesity. Published in New England Journal of Medicine, 2024. Tirzepatide produced significant reductions in apnea-hypopnea index, body weight, and patient-reported sleep disturbance. The trial supported the December 2024 FDA approval of Zepbound for moderate-to-severe OSA in adults with obesity — the first medication ever approved for this indication.
Head-to-head trial comparing tirzepatide to semaglutide 2.4 mg (Wegovy) in adults with obesity without diabetes. Results released in late 2024 showed tirzepatide produced greater weight loss than semaglutide at the maximum approved obesity doses. Specific magnitude favors tirzepatide; results were a major clinical milestone given prior dependence on indirect comparisons.
SURMOUNT-5 — the head-to-head trial of tirzepatide vs semaglutide 2.4 mg in adults with obesity — showed superior weight loss with tirzepatide. Prior to SURMOUNT-5, comparisons relied on indirect cross-trial analysis (SURMOUNT-1 vs STEP-1), which consistently suggested tirzepatide produced greater weight loss.
SURMOUNT-4 directly addressed this question. Participants switched to placebo regained a substantial fraction of their prior weight loss over the following 52 weeks. Continued tirzepatide maintained and modestly extended the loss. The trial supports chronic, long-term therapy.
Yes — in December 2024, Zepbound received FDA approval for moderate-to-severe obstructive sleep apnea in adults with obesity, based on the SURMOUNT-OSA trial. It is the first medication ever approved for OSA.
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