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On April 28, 2023, we reported on topline findings from the SURMOUNT-2 clinical trial, the second phase 3 study that evaluated the efficacy and safety of tirzepatide for chronic weight management.
SURMOUNT-2 evaluated 938 adults with overweight or obesity and type 2 diabetes (T2D) for 72 weeks. Investigators randomized participants in a 1:1:1 ratio to receive tirzepatide 10 mg, tirzepatide 15 mg, or placebo. The trial’s coprimary endpoints were mean percentage change in body weight from baseline and the percentage of patients achieving a body weight reduction of 5% or more at 72 weeks compared to placebo, said Lilly in the release. Secondary endpoints included reductions in Hgb A1C and other cardiometabolic parameters.
All participants randomized to the 2 active treatment arms began the study at a dose of 2.5 mg tirzepatide once weekly followed by stepwise increases every 4 weeks until the goal doses of 10 mg or 15 mg were reached. Study participants had a mean baseline body weight of 222 lb and baseline A1C of 8.0%.
SURMOUNT-2 investigators reported mean weight changes among tirzepatide-treated participants of -13.4% for those receiving 10 mg and of -15.7% for those on 15 mg compared to a change of -3.3% in participants receiving placebo.
The majority of participants receiving tirzepatide 10 mg and 15 mg achieved body weight reduction of at least 5% compared with placebo, ie, 81.6%, 86.4%, and 30.5%, respectively.
SURMOUNT-2 also met all its key secondary endpoints, with 41% of participants in the 10 mg and 51.8% of those in the 15 mg study arms losing at least 15% of their baseline body weight compared to 2.6% of those taking placebo.