Eli Lilly’s Tirzepatide Succeeds in 2 More Late-Stage Obesity Trials Ahead of FDA Decision

Tirzepatide: Eli Lilly’s Breakthrough Drug for Obesity

Source – Eli Lilly

Eli Lilly continues to gather strong evidence supporting the effectiveness of tirzepatide, its dual GIP/GLP-1 agonist, as a potent weight loss treatment.

Known as Mounjaro when used for its approved indication in type 2 diabetes, tirzepatide demonstrated remarkable weight loss results in two trials, Surmount-3 and Surmount-4. Participants in these trials achieved weight loss of up to 26.6% of their body weight, meeting all primary endpoints as stated by Lilly on Thursday.

In Surmount-3, the trial involved obese or overweight adults who underwent a 12-week intensive lifestyle intervention lead-in period, including a low-calorie diet, exercise, and weekly counseling sessions. Participants who qualified for the trial had to lose at least 5% of their body weight during this lead-in period. Those on tirzepatide lost an additional 21.1% of their body weight from randomization over the 72-week duration, while the placebo group experienced an average weight regain of 3.3%.

Related: Medicare Prescription Coverage For Obesity Is Supported By Legislation By Novo Nordisk, Eli Lilly, And Boehringer Ingelheim

Surmount-4, on the other hand, examined the safety and efficacy of tirzepatide over 52 weeks following a 36-week open-label tirzepatide lead-in period, where all participants received Lilly’s drug. During the Surmount-4 lead-in period, participants lost an average of 21.1% of their body weight. Those who continued with tirzepatide experienced an additional 6.7% weight loss during the trial, while patients on placebo regained an average of 14.8% of their body weight.

Lilly plans to present full results from Surmount-3 and Surmount-4 at upcoming conferences focused on obesity and diabetes research, respectively.

These positive outcomes follow a successful Phase III Surmont-2 study, where tirzepatide helped diabetic patients who were obese or overweight achieve weight loss of up to 15.7%. The drug significantly outperformed placebo across various weight loss and metabolic measurements, meeting its co-primary objectives and all key secondary endpoints.

Tirzepatide’s efficacy is not limited to diabetic patients, as it also demonstrated positive results in the Surmount-1 study involving non-diabetic patients. Based on the results of the first two Phase III trials, Lilly has completed a rolling submission for the drug in adults with obesity or overweight, with a potential approval expected this year.

Related: National Institute For Health And Care Excellence Remains Skeptical About The Effectiveness Of Mounjaro For Diabetes

Despite not yet having an official approval for obesity treatment, Mounjaro (tirzepatide) has become increasingly popular, leading to supply shortages in some doses. The US FDA recently added a fourth dose of the medication to its drug shortage database, and supply issues with three other doses are expected to persist until September 2023. The demand for Mounjaro has surged due to its promising results and potential as an effective weight loss agent.

Share This News