Source – Eli Lilly
On June 24, 2023, Eli Lilly and Company’s tirzepatide showed promising results in the SURMOUNT-2 Phase III clinical trial, which evaluated its effectiveness and safety for chronic weight management in individuals with obesity or overweight and type 2 diabetes. The detailed findings, presented at the American Diabetes Association’s 83rd Scientific Sessions and published in The Lancet, revealed that both doses of tirzepatide (10 mg and 15 mg) outperformed the placebo regarding weight reduction.
Tirzepatide successfully met both efficacy estimands’ co-primary endpoints and key secondary endpoints. Participants taking tirzepatide achieved a mean weight reduction of 13.4% (10 mg) and 15.7% (15 mg) compared to 3.3% with the placebo for the efficacy estimand. Moreover, a significant percentage of individuals on tirzepatide (81.6% for 10 mg and 86.4% for 15 mg) achieved at least a 5% reduction in body weight compared to 30.5% of those on the placebo.
“People living with type 2 diabetes in many cases have been exposed to excess weight for years and often face increased difficulties in achieving weight loss results, typically losing 30% less weight than those who have obesity without type 2 diabetes. They need options to help overcome those challenges and achieve meaningful weight reductions. Tirzepatide not only helped people achieve body weight reductions of up to 15.7%, but also helped significantly lower A1C without severe hypoglycemia and improved other cardiometabolic endpoints.”
– W. Timothy Garvey, MD, MACE, MABOM, Professor of Medicine at the University of Alabama at Birmingham (UAB), Director of the UAB Diabetes Research Center and Principal Investigator of SURMOUNT-2
At the 72-week mark, both tirzepatide doses demonstrated positive outcomes for various secondary endpoints, including achieving ≥15% and ≥20% body weight reductions, A1C levels below 5.7%, reduction in waist circumference, and fasting glucose levels. Furthermore, pooled tirzepatide doses significantly improved systolic blood pressure, fasting triglycerides, HDL-cholesterol, and non-HDL-cholesterol compared to the placebo.
Regarding the treatment-regimen estimand, which represents the average results of all study participants regardless of treatment adherence, tirzepatide consistently met the co-primary and key secondary endpoints, including body weight reductions and A1C levels.
The safety profile of tirzepatide aligned with previous SURMOUNT and SURPASS trials and was similar to approved incretin-based therapies for obesity and overweight. The most commonly reported adverse events were gastrointestinal-related, with mild to moderate severity, mostly occurring during the dose-escalation period.
The U.S. regulatory submission for tirzepatide in adults with obesity or overweight and weight-related comorbidities is expected to undergo review by the end of 2023.
