SURMOUNT-1

Study record

Population

2,539 adults; BMI ≥30, or ≥27 with a weight-related complication; diabetes excluded.

Read source · Full-text reportParticipants, pages 206 and 208 (primary report archived by USPTO)

Formulation

Sponsor-supplied tirzepatide or matching placebo in single-dose autoinjector pens. This trial preparation is not interchangeable with an unspecified research product.

Read source · Study protocolSection 6.1 and 6.1.1, page 56

Route

Subcutaneous injection

Read source · Full-text reportProcedures, page 207 (primary report archived by USPTO)

Dose & frequency

Trial escalation: 2.5 mg weekly initially, increasing by 2.5 mg every 4 weeks to the assigned 5, 10, or 15 mg dose. Escalation lasted up to 20 weeks. Describes supervised study treatment.

Read source · Full-text methodsMethods — dose-escalation scheme; Fixed-dose efficacy and safety studies — Study design

Study design

Phase 3, double-blind, placebo-controlled; 1:1:1:1 randomization, stratified by country, sex, and glycemic status. Lifestyle counseling accompanied treatment: a 500-kcal daily deficit and at least 150 minutes of weekly activity.

Read source · Full-text methodsMethods — lifestyle intervention; Fixed-dose efficacy and safety studies — Study design

Duration

Primary treatment period: 72 weeks. Participants with baseline prediabetes were planned to continue to 176 weeks total; that extended period is separate from the 72-week outcomes shown here.

Read source · Full-text methodsTable 1; Fixed-dose efficacy and safety studies — Study design

Reported findings

At 72 weeks, mean weight change (95% CI): 5 mg −15.0% (−15.9 to −14.2); 10 mg −19.5% (−20.4 to −18.5); 15 mg −20.9% (−21.8 to −19.9); placebo −3.1% (−4.3 to −1.9). Treatment-regimen analysis includes participants regardless of treatment discontinuation; these are group estimates, not individual predictions.

Read source · Full-text reportStatistical analysis; Results — Change in body weight; Figure 1A and Table 2 (cached publisher text)

Adverse events

Gastrointestinal events predominated. Adverse-event discontinuation: 4.3%, 7.1%, and 6.2% for 5, 10, and 15 mg versus 2.6% for placebo. Serious adverse events: 6.3%, 6.9%, and 5.1% versus 6.8%. Events occurring during a trial are not necessarily caused by treatment.

Read source · Full-text reportAdverse events; Table 4, page 214 (primary report archived by USPTO)

Monitoring

Additional safety measures included pulse, pancreatic enzymes, liver enzymes, calcitonin, and urine albumin-to-creatinine ratio. Table S7 reports model-based estimates with standard errors, not individual results or a personal monitoring schedule.

Read source · Supplementary materialTable S7, printed page 33 (PDF page 34)