Lilly’s tirzepatide shows superior weight reduction in phase 3 trial

Eli Lilly and Company (Lilly) said that tirzepatide has shown superior efficacy over placebo in chronic weight management, according to the results from the phase 3 clinical trial SURMOUNT-2.

Tested on patients with obesity or overweight and type 2 diabetes, the trial reported that tirzepatide, at doses of 10 mg and 15 mg, led to a significant weight reduction in contrast to the placebo. These findings were unveiled at the American Diabetes Association’s (ADA) 83rd Scientific Sessions and concurrently published in The Lancet.

The SURMOUNT-2 study confirmed that tirzepatide met both co-primary endpoints and all key secondary endpoints, demonstrating a mean weight reduction of 13.4% (10 mg) and 15.7% (15 mg) compared to 3.3% with placebo. Additionally, over 80% of participants taking tirzepatide achieved at least a 5% body weight reduction, while this percentage was around 30% for the placebo group.

Lilly’s tirzepatide outperforms placebo in chronic weight management in phase 3 clinical trial. Photo courtesy of Momoneymoproblemz/Wikimedia Commons.

All key secondary endpoints were achieved by both doses of tirzepatide at the 72-week treatment mark, including improvements in waist circumference, fasting glucose, and significant reduction in body weight. Other measures, such as systolic blood pressure, fasting triglycerides, HDL-cholesterol, and non-HDL-cholesterol, also saw substantial improvements compared to placebo.

Mike Mason — Executive Vice President and President, Lilly Diabetes and Obesity, said: “At Lilly, bringing new treatments to people with obesity is a priority and we are proud to share more evidence that solidifies our belief in tirzepatide as a treatment that will impact the way patients manage this disease.

“With these results in hand, we have completed our submission for chronic weight management to the U.S. FDA. We look forward to the future of obesity care and the opportunity to bring potential new treatments, like tirzepatide, to people with obesity and overweight.”

In terms of safety, tirzepatide’s profile was in line with the previously reported SURMOUNT and SURPASS trials, with the most frequently reported adverse events being gastrointestinal-related and generally mild to moderate in severity. The once-weekly GIP and GLP-1 receptor agonist is anticipated to receive regulatory approval in the US for adults with obesity or overweight and weight-related comorbidities by the end of 2023.