6/29/23, 11:57 PM SURMOUNT-1 (high-dose) Pathway Feedback Search Clinical Topics Home Studies SURMOUNT 1 (high-dose) SURMOUNT 1 (high-dose) Disease Obesity Trial question What is the role of a high dose of tirzepatide in people with obesity? Study design Multi-center Double blinded RCT Population Characteristics of study participants 68.0% female N = 1273 32.0% male 1273 patients (861 female, 412 male) Inclusion criteria: adults with a BMI > 30, or > 27 and at least one weight-related complication, excluding diabetes Key exclusion criteria: diabetes; a change in body weight > 5 kg within 90 days before screening; previous or planned surgical treatment for obesity; treatment with a medication that promotes weight loss within 90 days before screening Interventions N=630 high-dose tirzepatide (a subcutaneous dose of 15 mg once weekly for 72 weeks) N=643 placebo (matching placebo once-weekly) Primary outcome https://web.pathway.md/studies/rec4enXnXQc74FNN1 1/2 6/29/23, 11:57 PM SURMOUNT-1 (high-dose) Pathway Weight reduction at week 72 20.9 % 20.9 15.7 % 10.4 % Significant increase 5.2 % NNT = 6 3.1 0.0 % High-dose tirzepatide Placebo Significant increase in weight reduction at week 72 (20.9% vs. 3.1%; AD 17.8%, 95% CI 16.3 to 19.3) Secondary outcomes Significant increase in the percentage of patients achieving a weight reduction of 5% at week 72 (90.9% vs. 34.5%; AD 56.4%, 95% CI 22.93 to 89.87) Significant increase in the percentage of patients achieving a weight reduction of 10% at week 72 (83.5% vs. 18.8%; AD 64.7%, 95% CI 26.31 to 103.09) Significant increase in reduction in waist circumference (18.5 cm vs. 4 cm; AD 14.5 cm, 95% CI 5.9 to 23.1) Safety outcomes No significant difference in serious adverse events. Conclusion In adults with a BMI > 30, or > 27 and at least one weight-related complication, excluding diabetes, high-dose tirzepatide was superior to placebo with respect to weight reduction at week 72. Reference Ania M Jastreboff, Louis J Aronne, Nadia N Ahmad et al. Tirzepatide Once Weekly for the Treatment of Obesity. N Engl J Med. 2022 Jul 21;387(3):205-216. Open reference URL https://web.pathway.md/studies/rec4enXnXQc74FNN1 2/2