SURMOUNT-2 (tirzepatide 10 mg)
Trial question
What is the role of once-weekly tirzepatide in patients with obesity and T2DM?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
51.0% female
49.0% male
N = 627
627 patients (317 female, 310 male).
Inclusion criteria: adult patients with BMI ≥ 27 kg/m² and HbA1c 7-10%.
Key exclusion criteria: change in bodyweight > 5 kg within 3 months before screening; previous or planned surgical treatment for obesity; treatment with anti-obesity medications, DPP4 inhibitors, oral GLP-1 receptor agonist, or any injectable therapy for T2DM within 3 months before screening.
Interventions
N=312 tirzepatide (initiated at 2.5 mg SC once weekly and increased by 2.5 mg every 4 weeks to a maintenance dose of 10 mg once weekly, and continued for a total of 72 weeks).
N=315 placebo (matching placebo once weekly for 72 weeks).
Primary outcome
Least-squares mean reduction in body weight at week 72
12.8%
3.2%
12.8 %
9.6 %
6.4 %
3.2 %
0.0 %
Tirzepatide
Placebo
Significant
increase ▲
NNT = 10
Significantly greater reduction in least-squares mean body weight at week 72 (12.8% vs. 3.2%; ETD 9.6, 95% CI 8.1 to 11.1).
Secondary outcomes
Significant increase in the percentage of patients achieving a weight reduction of ≥ 5% at week 72 (79% vs. 32%; OR 8.3, 95% CI 5.6 to 12.3).
Significant increase in the percentage of patients achieving a weight reduction of ≥ 10% at week 72 (61% vs. 9%; OR 16.1, 95% CI 9.9 to 26.1).
Significantly greater reduction in HbA1c at week 72 (2.07% vs. 0.51%; ETD 1.55, 95% CI 1.37 to 1.74).
Safety outcomes
No significant difference in ≥ 1 treatment-emergent adverse events or serious adverse events.
Conclusion
In adult patients with BMI ≥ 27 kg/m² and HbA1c 7-10%, tirzepatide was superior to placebo with respect to a least-squares mean reduction in body weight at week 72.
Reference
W Timothy Garvey, Juan P Frias, Ania M Jastreboff et al. 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. Lancet. 2023 Aug 19;402(10402):613-626.
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