Lilly reports full phase 3 trial data of Mounjaro for weight loss (NYSE:LLY)
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Eli Lilly (NYSE:LLY) reported full results from a phase 3 trial of its drug Mounjaro (tirzepatide) to treat obesity or overweight in Nature Medicine and also presented it at the ObesityWeek 2023 conference.
Mounjaro, which was approved in in the U.S. in May 2022, is an injectable medicine, used with diet and exercise, to improve blood sugar (glucose) in adults with type 2 diabetes. The drug is currently under review in the U.S. and EU for adults with obesity or overweight with weight-related comorbidities.
In July, the company had reported results from the SURMOUNT-3 and SURMOUNT-4 trials.
The phase 3 study, dubbed SURMOUNT-3, enrolled 806 people and evaluated tirzepatide in adults with obesity or overweight with weight-related comorbidities, excluding type 2 diabetes. The trial met its both co-primary goal by showing superiority to placebo during the 72-week double-blind treatment period.
The study evaluated tirzepatide compared to placebo for 72 weeks after a 12-week intensive lifestyle intervention lead-in period which included a low-calorie diet, exercise and counseling sessions. At study entry, the average body weight was 241.4 lb. (109.5 kg).
After 12 weeks, 579 people achieved at least 5% body weight reduction and were randomized to receive either tirzepatide or placebo.
At the end of the 12-weeks, people achieved 6.9% (7.6 kg or 16.8 lb.) average weight loss. In a co-primary goal, after the lead-in period, participants on tirzepatide achieved an additional 21.1% mean weight loss, according to Lilly (LLY).
In a secondary objective, people achieved a total mean weight loss of 26.6% (29.2 kg or 64.4 lb.) from study entry over 84 weeks.
Participants on placebo saw a total mean weight loss of 3.8% (4.1 kg or 9.0 lb.) from study entry over 84 weeks.
“In this study, people who added tirzepatide to diet and exercise saw greater, longer-lasting weight reduction than those taking placebo,” said Jeff Emmick, Ph.D., senior vice president, product development, Lilly.
The company noted that the most commonly reported adverse events in the study were gastrointestinal-related and were generally mild to moderate in severity.
Lilly (LLY) added that the overall safety profile of tirzepatide in SURMOUNT-3 was similar to previously reported SURMOUNT and SURPASS trials.
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