6/29/23, 11:57 PM SURMOUNT-1 (low-dose) Pathway Feedback Search Clinical Topics Home Studies SURMOUNT 1 (low-dose) SURMOUNT 1 (low-dose) Disease Obesity Trial question What is the role of a low 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 (862 female, 411 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 low-dose of tirzepatide (a subcutaneous dose of 5 mg once weekly for 72 weeks) N=643 placebo (matching placebo once-weekly) Primary outcome https://web.pathway.md/studies/rec1AwLkzb1EjQ296 1/2 6/29/23, 11:57 PM SURMOUNT-1 (low-dose) Pathway Weight reduction at week 72 15.0 % 15 11.3 % 7.5 % Significant increase 3.8 % NNT = 8 3.1 0.0 % Low-dose of tirzepatide Placebo Significant increase in weight reduction at week 72 (15% vs. 3.1%; AD 11.9%, 95% CI 10.4 to 13.4) Secondary outcomes Significant increase in the percentage of patients achieving a weight reduction of 5% at week 72 (85.1% vs. 34.5%; AD 50.6%, 95% CI 20.58 to 80.62) Significant increase in the percentage of patients achieving a weight reduction of 10% at week 72 (68.5% vs. 18.8%; AD 49.7%, 95% CI 20.21 to 79.19) Significant increase in reduction in waist circumference (14 cm vs. 4 cm; AD 10.1 cm, 95% CI 4.11 to 16.09) 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, low-dose of 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/rec1AwLkzb1EjQ296 2/2