Efficacy and Safety of Tirzepatide Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-1)

Official Summary

This Phase 3 study evaluates the efficacy and safety of once-weekly subcutaneous tirzepatide (a dual GIP and GLP-1 receptor agonist) at 5 mg, 10 mg, or 15 mg versus placebo, each used with a reduced-calorie diet and increased physical activity, in adults without type 2 diabetes who have obesity or are overweight with weight-related comorbidities. The primary efficacy assessment is at Week 72. Participants with prediabetes at randomization may continue in an additional long-term treatment period to assess progression to type 2 diabetes and longer-term weight outcomes.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: DOUBLE
• Enrollment: 2,539 participants

Interventions

• DRUG: Tirzepatide — (once-weekly SC injection; doses 5/10/15 mg)
• DRUG: Placebo — (once-weekly SC injection)
• BEHAVIORAL: Reduced-calorie diet — increased physical activity counseling

Primary Outcomes

• Mean percent change in body weight from randomization (72 Weeks)
• Percentage of participants achieving ≥5% body weight reduction from randomization (72 Weeks)

Secondary Outcomes

• Mean change in body weight (72 Weeks)
• Changes in cardiometabolic measures in triglycerides (72 weeks)

Trial Locations

• Peking University Shenzhen Hospital, Shenzhen, Guangdong, China

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