Lilly's tirzepatide shows additional 21.1% weight loss after 12 weeks of intensive lifestyle intervention, for a total mean weight loss of 26.6% from study entry over 84 weeks

Eli Lilly and Company has released the full results of its SURMOUNT-3 clinical trial, which evaluated the efficacy of tirzepatide in adults with obesity or overweight and weight-related comorbidities. The trial, which included a 12-week intensive lifestyle intervention lead-in period, demonstrated that tirzepatide was superior to placebo in achieving weight loss during the 72-week double-blind treatment period.

The results of the SURMOUNT-3 trial were published in Nature Medicine and presented at ObesityWeek® 2023. The trial involved 806 participants who had at least a 5% body weight reduction by the end of the lead-in period. Participants were then randomized to receive either tirzepatide or placebo.

The study found that participants taking tirzepatide achieved an additional 21.1% mean weight loss after the lead-in period, resulting in a total mean weight loss of 26.6% from study entry over 84 weeks. In comparison, participants on placebo achieved a total mean weight loss of 3.8% over the same period.

Dr. Jeff Emmick, Senior Vice President of Product Development at Lilly, highlighted the significance of these findings, stating, “In this study, people who added tirzepatide to diet and exercise saw greater, longer-lasting weight reduction than those taking placebo. While intensive lifestyle intervention is an important part of obesity management, these results underscore the difficulty some people face maintaining weight loss with diet and exercise alone.”

The safety profile of tirzepatide in the SURMOUNT-3 trial was similar to previous trials, with the most commonly reported adverse events being gastrointestinal-related and generally mild to moderate in severity. Adverse events led to discontinuation of study treatment in 10.5% of participants taking tirzepatide and 2.1% taking placebo.

Tirzepatide is a once-weekly GIP receptor and GLP-1 receptor agonist that activates the body’s receptors for GIP and GLP-1, natural incretin hormones involved in appetite regulation. It is currently under review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for adults with obesity or overweight and weight-related comorbidities.

The SURMOUNT clinical trial program for tirzepatide began in 2019 and has enrolled over 5,000 individuals across six registration studies. The program aims to evaluate the potential of tirzepatide in chronic weight management and its effectiveness in treating other conditions such as heart failure, sleep apnea, and non-alcoholic steatohepatitis.

Eli Lilly and Company is committed to making life better for people around the world through its pioneering discoveries and innovative medicines. With a focus on addressing significant health challenges, the company aims to improve the lives of millions of individuals by providing accessible and affordable treatments.

Overall, the results of the SURMOUNT-3 trial demonstrate the potential of tirzepatide as an effective treatment for weight loss in individuals with obesity or overweight and weight-related comorbidities. These findings offer hope for those struggling to maintain weight loss through diet and exercise alone, providing a new option for long-lasting weight reduction.