Direct study · 2023

SURMOUNT-2

Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial.

Garvey WT, Frias JP, Jastreboff AM, le Roux CW, Sattar N, Aizenberg D, Mao H, Zhang S, Ahmad NN, Bunck MC, Benabbad I, Zhang XM, SURMOUNT-2 investigators. · Lancet (London, England)

Study record

Population: 938 adults with overweight/obesity and type 2 diabetes; HbA1c 7–10%.
Read source · Abstract-level extractionPrimary abstract — Methods and Results
Formulation: Sponsor-supplied tirzepatide or placebo in single-dose autoinjector pens. 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-GPHL, Section 6.1, printed page 42
Route: Subcutaneous injection.
Read source · Abstract-level extractionPrimary abstract — Methods and Results
Dose & frequency: 10 or 15 mg once weekly. These are assigned maintenance doses, not starting-dose instructions.
Read source · Abstract-level extractionPrimary abstract — Methods and Results
Study design: Phase 3, double-blind, randomized 1:1:1 versus placebo.
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: −12.8% and −14.7% versus −3.2% placebo; treatment-regimen analysis.
Read source · Abstract-level extractionPrimary abstract — Methods and Results
Adverse events: Participants with serious adverse events — Placebo: 23/315; 10 mg Tirzepatide: 18/312; 15 mg Tirzepatide: 27/311. Events are not necessarily treatment-caused.
Read source · Registry resultsResults — Adverse Events, Serious Adverse Events summary; Baseline through Week 76
Monitoring: Protocol-planned monitoring: Physical examination, vital signs and single 12-lead ECGs; investigator laboratory review. Clinically significant abnormal labs during treatment or within four weeks after last dose repeated until normalized, baseline or no longer clinically significant. 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 57–58

What it supports

Addresses SURMOUNT-2 outcomes in its specified population and comparison.

What it does not establish

Diabetes population; do not directly rank these outcomes against trials excluding diabetes. Abstract/registry extraction; unverified full-text details remain flagged.

Funding

Eli Lilly funded the study (primary abstract).

Publication and registry context

The registry reports week-72 weight changes of −13.4% and −15.7% versus −3.3%, with endpoint populations of 309, 309 and 311. These differ from the publication treatment-regimen estimates above. The registry also reports at least 5% weight loss in 81.55%, 86.41% and 30.55%. Safety denominators are 312, 311 and 315, with follow-up through week 76. Endpoint and safety populations are not interchangeable.

Inspect NCT04657003 results

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

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