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Trial Results Position Mounjaro for Weight Loss Drug Approval

Published: 4/28/23 10:30 am
By Susannah Chen

Eli Lilly’s SURMOUNT-2 trial clinical trial results show substantial weight loss in people with type 2 diabetes taking Mounjaro (tirzepatide) at high doses, positioning the injectable drug for FDA approval as an obesity drug.

Drug maker Eli Lilly released data on April 27 from a clinical trial that demonstrates its tirzepatide medication Mounjaro is effective and safe for chronic weight management in adults with type 2 diabetes with obesity or overweight.

Lilly says the data will be used together with earlier data to fast-track approval for Mounjaro for weight loss, setting it up to compete directly against Novo Nordisk’s highly buzzed-about blockbuster weight loss drug Wegovy (available for diabetes management at lower doses under the name brand Ozempic) as early as the end of this year.

In Lilly’s SURMOUNT-2 global phase 3 clinical trial, 938 adult participants with type 2 diabetes and obesity or overweight took either weekly treatments of 15 mg tirzepatide, 10 mg tirzepatide, or placebo for 72 weeks.

Participants taking the highest dose achieved weight reductions of 15.7% on average of their body weight, losing up to 34.4 lbs (15.6 kg); while those taking 10 mg dose lost up to 13.4%, or 29.8 lbs (13.5 kg).

In comparison, participants in the placebo group only lost an average of 3.3%, or 7 lbs (3.2 kg) over the 72 weeks.

Lilly also reported that nearly 4 out of every 5 participants achieved a body weight reduction of more than 5%, and nearly 2 out of every 5 participants achieved a body weight reduction of more than 15%.

A Lilly clinical trial last year in people with obesity but not diabetes, called SURMOUNT-1, tested tirzepatide 5 mg, 10 mg, or 15 mg. The results, published in the New England Journal of Medicine, showed participants lost an average of 52 pounds – more than 20% of their weight – on the highest dose.

Mounjaro is currently only approved to improve control of blood glucose in adults with type 2 diabetes. Lillly stated that it plans to submit the new results to a peer-reviewed journal and that it plans to use these results, along with data from previous clinical trials, to ask for accelerated approval of Mounjaro as a weight loss and obesity drug.

The company expects a decision on FDA approval as soon as later this year. FDA approval of tirzepatide for weight loss would position Mounjaro to join a class of medications that have emerged as extremely effective weight loss and diabetes treatments, and have quickly gained star status as so-called miracle drugs for weight loss in celebrity and social media circles, leading to a surge in demand as well as a global shortage. (While similar to GLP-1 receptor agonist medications, tirzepatide is a dual GIP and GLP-1 receptor agonist.)

A series of trials have attempted to compare tirzepatide’s effectiveness against semaglutide. Lilly is currently recruiting participants for a major clinical trial that directly compares weight loss with Mounjaro directly against Wegovy.

Photo Credit: Julie Keller Heverly

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About the authors

Prior to joining The diaTribe Foundation in 2023, Susannah Chen was a longtime freelance writer and editorial content strategist with a focus on food, drink, and travel. A two-year saga... Read the full bio »