Tirzepatide for the treatment of obesity: Rationale and design of the SURMOUNT clinical development program.

ABSTRACT:

Objective

Obesity is a growing global concern compounded by limited availability of effective treatment options. The SURMOUNT development program aims to evaluate the efficacy and safety of tirzepatide as an adjunct to lifestyle intervention compared with placebo on chronic weight management in adults with BMI ≥ 27 kg/m² with or without type 2 diabetes.

Methods

The SURMOUNT program includes four global phase 3 trials NCT04184622 (SURMOUNT-1), NCT04657003 (SURMOUNT-2), NCT04657016 (SURMOUNT-3), and NCT04660643 (SURMOUNT-4). Participants are randomized to once-weekly subcutaneous tirzepatide versus placebo in a double-blind manner. The primary end point in all trials is the percentage change in body weight from randomization to end of treatment. Results for the prim

SUBMITTER: le Roux CW 

PROVIDER: S-EPMC10107501 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature