SURMOUNT-3
Trial question
What is the role of tirzepatide in adult patients with overweight or obesity who underwent intensive lifestyle intervention?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
63.0% female
37.0% male
N = 579
579 patients (364 female, 215 male).
Inclusion criteria: adult patients with a BMI ≥ 30 or ≥ 27 kg/m² and at least one obesity-related complication, who achieved ≥ 5.0% weight reduction after a 12-week intensive lifestyle intervention.
Key exclusion criteria: T1DM, T2DM, ketoacidosis, or hyperosmolar state/coma; self-reported change in body weight > 5 kg within 3 months before screening; previous planned surgical treatment for obesity; history of chronic or acute pancreatitis.
Interventions
N=287 tirzepatide (initiated at 2.5 mg SC once weekly and increased by 2.5 mg every 4 weeks to a maximum tolerated dose of 10 mg or 15 mg once weekly, and continued for a total of 72 weeks).
N=292 placebo (matching placebo once weekly for 72 weeks).
Primary outcome
Reduction in weight at week 72
18.4%
-2.5%
18.4 %
13.8 %
9.2 %
4.6 %
0.0 %
-4.6 %
Tirzepatide
Placebo
Significant
increase ▲
NNT = 4
Significantly greater reduction in weight at week 72 (18.4% vs. -2.5%; ARD 20.8, 95% CI 18.5 to 23.2).
Secondary outcomes
Significant increase in the percentage of patients achieving a weight reduction of ≥ 5% at week 72 (87.5% vs. 16.5%; OR 34.6, 95% CI 19.2 to 62.6).
Significant increase in the percentage of patients achieving a weight reduction of ≥ 10% at week 72 (76.7% vs. 8.9%; OR 34.7, 95% CI 17.6 to 68.3).
Significantly greater reduction in waist circumference (14.6 cm vs. -0.2 cm; AD 14.8 cm, 95% CI 12.5 to 17.2).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In adult patients with a BMI ≥ 30 or ≥ 27 kg/m² and at least one obesity-related complication, who achieved ≥ 5.0% weight reduction after a 12-week intensive lifestyle intervention, tirzepatide was superior to placebo with respect to reduction in weight at week 72.
Reference
Thomas A Wadden, Ariana M Chao, Sriram Machineni et al. Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. Nat Med. 2023 Nov;29(11):2909-2918.
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