Nearly 18-times more patients on trizepatide 15 mg achieved a body weight reduction of 15% or more compared to placebo.
Patients with obesity and type 2 diabetes (T2D) or with overweight and T2D lost an estimated 34.4 pounds (15.7%) of body weight with 10 mg and 15 mg of tirzepatide (Mounjaro; Eli Lilly and Company), according to findings from the SURMOUNT-2 global phase 3 trial. Specifically, tirzepatide at 10 mg reduced body weight by 5% or more in 79.2% of patients and reduced average body weight by 12.8%, while the 15 mg dose reduced weight in 82.7% of patients and decreased average body weight by 14.7%.
"Obesity is a difficult-to-manage disease, and it's even more difficult for people living with type 2 diabetes," said Jeff Emmick, MD, PhD, senior vice president, product development, Lilly, in a recent press release. "The degree of mean weight reduction seen in SURMOUNT-2 has not been previously achieved in phase 3 trials for obesity or overweight and type 2 diabetes."
Tirzepatide is a GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagon-like peptide-1) receptor agonist; GIP and GLP-1 receptors regulate appetite. The once-weekly molecule acts on these receptors to decrease food intake and modulate the body’s use of fat.
More than 5000 patients with obesity or overweight have enrolled in the SURMOUNT phase 3 global clinical program since late 2019. SURMOUNT is evaluating tirzepatide for chronic weight management in adults with obesity or overweight and weight-related comorbidities.
SURMOUNT-2 (NCT04657003) was a multi-center, randomized, double-blind, parallel, placebo-controlled trial in the SURMOUNT clinical program. Investigators compared the efficacy and safety of tirzepatide at 10 mg and 15 mg to placebo as an adjunctive therapy to a reduced-calorie diet and increased physical activity in adults with obesity or overweight and type 2 diabetes.
Primary endpoints were superiority of tirzepatide 10 mg and/or 15 mg for average percent change in body weight from baseline compared to placebo, and percent of participants on tirzepatide with a 5% or more increase in body weight reduction at 72 weeks compared to placebo. The trial enrolled 938 patients worldwide who were randomized 1:1:1 to receive tirzepatide at 10 mg or 15 mg, or given placebo.
Tirzepatide 15 mg was most effective for body weight reduction of 15% or more. A 15% reduction in body weight was achieved in 48% of patients on tirzapetide 15 mg, 39.7% of patients on tirzapetide 10 mg, and 2.7% of patients on placebo.
The overall safety profile was consistent with previously reported SURMOUNT and SURPASS trials. The most common adverse events (AEs) included mild to moderate gastrointestinal-related issues during escalation. Patients experienced nausea (20.2% and 21.9% with 10 mg and 15 mg, respectively), diarrhea (19.9%, 21.5%), vomiting (10.9%, 13.2%), and constipation (8.0%, 9.0%).
Results from SURMOUNT-2 trial will be presented at the American Diabetes Association's 83rd Scientific Sessions. Lilly will submit results to a peer-reviewed journal and the FDA later this year.
Lilly's tirzepatide achieved up to 15.7% weight loss in adults with obesity or overweight and type 2 diabetes in SURMOUNT-2. News Release. April 27, 2023. Accessed on April 28, 2023. https://investor.lilly.com/news-releases/news-release-details/lillys-tirzepatide-achieved-157-weight-loss-adults-obesity-or