Eli Lilly and Company, a renowned pharmaceutical company, has unveiled the complete results from its Phase 3 trial of Mounjaro (tirzepatide) for the treatment of obesity or overweight. The findings were published in Nature Medicine and were also presented at the ObesityWeek 2023 conference.
- Eli Lilly’s Mounjaro is an injectable medicine designed to improve blood sugar levels in adults with type 2 diabetes.
- The drug received approval in the U.S. in May 2022.
- Mounjaro is currently under review in the U.S. and EU for adults with obesity or overweight who have weight-related comorbidities.
- The Phase 3 study, named SURMOUNT-3, enrolled 806 participants and evaluated tirzepatide in adults with obesity or overweight, excluding those with type 2 diabetes.
- The trial successfully met its primary objectives, demonstrating superiority over a placebo during a 72-week double-blind treatment period.
- Participants on tirzepatide achieved an additional 21.1% mean weight loss, according to Eli Lilly.
- A secondary goal revealed a total mean weight loss of 26.6% from the beginning of the study over 84 weeks.
The Phase 3 study, dubbed SURMOUNT-3, was designed to evaluate the efficacy of tirzepatide in adults with obesity or overweight conditions, excluding those diagnosed with type 2 diabetes. The trial successfully met its primary objectives by demonstrating a significant superiority over a placebo during a 72-week double-blind treatment period.
The study began with a 12-week intensive lifestyle intervention lead-in period, which included a low-calorie diet, exercise, and counseling sessions. At the start of the study, the average body weight of participants was 241.4 lb. (109.5 kg). After the 12-week lead-in period, 579 participants achieved a minimum of 5% body weight reduction and were subsequently randomized to receive either tirzepatide or a placebo. By the end of the 12-week period, participants had achieved an average weight loss of 6.9% (7.6 kg or 16.8 lb.).
In a co-primary objective, following the lead-in period, participants on tirzepatide achieved an additional 21.1% mean weight loss. In a secondary objective, participants achieved a total mean weight loss of 26.6% (29.2 kg or 64.4 lb.) from the start of the study over an 84-week period. In contrast, participants on the placebo reported a total mean weight loss of 3.8% (4.1 kg or 9.0 lb.) over the same 84-week period.
Jeff Emmick, Ph.D., senior vice president of product development at Eli Lilly, commented on the results, stating, “In this study, people who added tirzepatide to diet and exercise saw greater, longer-lasting weight reduction than those taking placebo.” The company also highlighted that the most commonly reported adverse events during the study were gastrointestinal-related and were generally mild to moderate in severity. Furthermore, Eli Lilly added that the overall safety profile of tirzepatide in the SURMOUNT-3 trial was consistent with previously reported SURMOUNT and SURPASS trials.
The introduction of Mounjaro and its potential approval for non-diabetic weight loss represents a significant advancement in the treatment of obesity and overweight conditions. The global obesity epidemic has been a growing concern for health professionals and policymakers alike. According to the World Health Organization, obesity has nearly tripled since 1975. In 2016, more than 1.9 billion adults were overweight, of which over 650 million were obese.
The potential approval of Mounjaro for non-diabetic weight loss could provide a new avenue for individuals struggling with weight management. The drug’s mechanism of action, combined with lifestyle interventions, could offer a comprehensive approach to weight loss, addressing both the physiological and behavioral aspects of obesity.
However, as with all medications, it’s essential for patients and healthcare providers to weigh the benefits against potential risks. While the results from the SURMOUNT-3 trial are promising, long-term studies will be crucial in determining the drug’s safety and efficacy over extended periods.
In conclusion, the results from Eli Lilly’s Phase 3 trial of Mounjaro offer hope to millions of individuals worldwide struggling with obesity and overweight conditions. As the pharmaceutical industry continues to innovate and develop new treatments, it’s crucial for regulatory bodies, healthcare providers, and patients to stay informed and make decisions based on comprehensive data and research.