Direct study · 2025

SURMOUNT-5

Tirzepatide as Compared with Semaglutide for the Treatment of Obesity.

Aronne LJ, Horn DB, le Roux CW, Ho W, Falcon BL, Gomez Valderas E, Das S, Lee CJ, Glass LC, Senyucel C, Dunn JP, SURMOUNT-5 Trial Investigators. · The New England journal of medicine

Study record

Population: 751 adults with obesity without type 2 diabetes.
Read source · Abstract-level extractionPrimary abstract — Methods and Results
Formulation: Sponsor-supplied tirzepatide in a locally marketed or investigational autoinjector, depending on marketing status, versus semaglutide in a locally marketed pen. This is the registered study preparation, not proof of equivalence to research products or verification of every administered batch.
Read source · Study protocolProtocol I8F-MC-GPHJ(c), Section 6.1–6.1.1, printed page 45
Route: Subcutaneous injection.
Read source · Abstract-level extractionPrimary abstract — Methods and Results
Dose & frequency: Maximum tolerated tirzepatide 10/15 mg versus semaglutide 1.7/2.4 mg once weekly.
Read source · Abstract-level extractionPrimary abstract — Methods and Results
Study design: Phase 3b, open-label randomized comparison with semaglutide.
Read source · Abstract-level extractionPrimary abstract — Methods and Results
Duration: 72 weeks.
Read source · Abstract-level extractionPrimary abstract — Methods and Results
Reported findings: Weight change: −20.2% (95% CI −21.4 to −19.1) versus −13.7% (−14.9 to −12.6).
Read source · Abstract-level extractionPrimary abstract — Methods and Results
Adverse events: Participants with serious adverse events — 15 mg or MTD - Tirzepatide: 18/374; 2.4 mg or MTD - Semaglutide: 13/376. Events are not necessarily treatment-caused.
Read source · Registry resultsResults — Adverse Events, Serious Adverse Events summary; Baseline Up To 72 Weeks
Monitoring: Protocol-planned monitoring: Physical examination includes cardiovascular, respiratory, GI, neurological and thyroid assessments. Vital signs and single 12-lead digital ECG; clinically significant diagnosed vital-sign changes after first dose reported as AEs. These planned assessments are not a personal monitoring schedule or proof every assessment occurred. Registry safety reporting and its observation window are cited separately under adverse events.
Read source · Study protocolSection 8.2, printed pages 58

What it supports

Addresses SURMOUNT-5 outcomes in its specified population and comparison.

What it does not establish

Compares obesity doses in people without diabetes; not SURPASS-2, a combination study, or proof that coadministration helps. Abstract/registry extraction; unverified full-text details remain flagged.

Funding

Eli Lilly funded the study (primary abstract).

Publication and registry context

The registry agrees with the reported −20.2% versus −13.7% weight change at week 72. Its endpoint table lists 318 evaluable participants per arm, whereas safety includes 374 receiving tirzepatide and 376 receiving semaglutide. Serious events were 18/374 and 13/376 through week 72. Matching estimates do not mean that every analysis uses the same population.

Inspect NCT05822830 results

Literature search cutoff: 2026-09-08 · Not independently clinically reviewed

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