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Recently, Eli Lilly and Company announced the latest clinical trial results of its diabetes therapy, Mounjaro (tirzepatide), at the American Diabetes Association (ADA) Scientific Sessions. The mechanism of action study of Mounjaro showed that, compared with placebo and active control, Mounjaro led to a greater reduction in fat mass in patients with type 2 diabetes. Exploratory analysis revealed that Mounjaro required less time for patients to reach glycated hemoglobin (A1C) and weight target levels compared to active control.
Mounjaro Recently Approved by U.S. FDA for Improving Blood Sugar Control in Adults with Type 2 Diabetes, in Combination with Diet and Exercise. It is a Dual Agonist of Glucose-Dependent Insulinotropic Polypeptide (GIP) and Glucagon-Like Peptide-1 (GLP-1) Receptors.
In this 28-week randomized, double-blind Phase 1 mechanism of action study, patients received treatment with Mounjaro (15 mg), injectable semaglutide (1 mg), or a placebo. The trial results showed that after 28 weeks, the average weight loss in the Mounjaro group was 11.2 kilograms, compared to 6.9 kilograms in the active control group and 0 kilograms in the placebo group (p<0.001). In terms of reduction in fat mass, the Mounjaro group showed a decrease of 9.7 kilograms, while the active control group showed 5.9 kilograms (p=0.002).
The study also showed that both Mounjaro and the active comparator significantly reduced patients' baseline energy intake as well as appetite indicators.
In addition, exploratory analyses of the Phase 3 clinical trials SURPASS-2 and SURPASS-3 showed that patients receiving Mounjaro reached the endpoints of A1C<7%, A1C≤6.5%, and weight reduction ≥5% in a shorter time compared to the active control groups. Specifically, the median time for the Mounjaro group to reach A1C<7% was 8 weeks, while it took 12 weeks for the two active controls. In achieving A1C≤6.5% and weight reduction ≥5%, the Mounjaro group required 12 weeks, whereas the two active controls required 16 and 24 weeks, respectively.
"We are pleased to report new mechanism of action data and new analyses from the SURPASS clinical development program. This helps us evaluate how Mounjaro can assist adult patients with type 2 diabetes in managing different aspects of the condition," said Dr. Laura Fernández Landó of Eli Lilly and Company's diabetes division.
References:
[1] New analyses of Mounjaro™ (tirzepatide) injection for the treatment of adults with type 2 diabetes presented at the American Diabetes Association's® 82nd Scientific Sessions®. Retrieved June 7, 2022, from https://investor.lilly.com/news-releases/news-release-details/new-analyses-mounjarotm-tirzepatide-injection-treatment-adults
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