Eli Lilly’s SURMOUNT-2 results show tirzepatide led to superior weight reduction

Detailed results from SURMOUNT-2, a phase 3 clinical trial evaluating the efficacy and safety of Eli Lilly’s tirzepatide for chronic weight management in participants with obesity or overweighti and type 2 diabetes, showed that tirzepatide led to superior weight reduction versus placebo for both doses. The data were presented during a symposium at the American Diabetes Association’s 83rd Scientific Sessions and were simultaneously published in The Lancet. Tirzepatide met both co-primary endpoints and all key secondary endpoints compared to placebo for both estimands, with those taking tirzepatide achieving a mean weight reduction of 13.4% on 10 mg and 15.7% on 15 mg compared to 3.3% on placebo for the efficacy estimand, which evaluates the treatment effect if all participants adhered to treatment. For the efficacy estimand, 81.6% and 86.4% of people taking tirzepatide achieved at least 5% body weight reduction, compared to 30.5% of those taking placebo. Both doses of tirzepatide achieved all key secondary endpoints at 72 weeks of treatment for the efficacy estimand. Additionally, tirzepatide met the co-primary and all key secondary endpoints for the treatment-regimen estimand, which represents the average results of all study participants regardless of treatment adherence. The overall safety profile of tirzepatide was consistent with previously reported SURMOUNT and SURPASS trials and similar to incretin-based therapies approved for the treatment of obesity and overweight. The most commonly reported adverse events were gastrointestinal-related and were generally mild to moderate in severity, and usually occurred during the dose-escalation period. Regulatory action for the U.S. submission for tirzepatide in adults with obesity, or overweight with weight-related comorbidities is expected by the end of 2023.