Eli Lilly Initiates Phase III Trial of Tirzepatide as First-Line Treatment for Type 2 Diabetes in China

On July 5, Eli Lilly and Company disclosed the Phase III SURPASS-CN-MONO study of tirzepatide for the treatment of patients with type 2 diabetes on the Drug Clinical Trial Registration and Information Disclosure Platform in China.

SURPASS-CN-MONO is a randomized, double-blind, placebo-controlled Phase III study designed to evaluate the efficacy and safety of tirzepatide monotherapy compared to placebo in patients with type 2 diabetes in China.The study plans to enroll 200 patients with type 2 diabetes, with the inclusion criterion that patients have not used any hypoglycemic agents within 90 days prior to Visit 1.(Except for short-term use (≤14 days) of insulin in certain clinical situations, such as acute illness, during hospitalization, or for elective surgery).

Tirzepatide is a once-weekly GLP-1R/GIPR dual agonist that was first approved by the FDA for marketing in May 2022. It is suitable for improving glycemic control in patients with type 2 diabetes based on diet and exercise. Notably, in September 2022, the marketing application for this indication was accepted by the regulatory authority in China.

Recently, Eli Lilly and Company also published the detailed results of the Phase III SURMOUNT-2 study on the efficacy and safety of Tirzepatide for long-term weight management in obese/overweight patients with type 2 diabetes in The Lancet.

Results showed that, compared with the placebo control group, subjects in the Tirzepatide group achieved both co-primary endpoints and all key secondary endpoints. Patients in the Tirzepatide 10mg and 15mg groups experienced an average weight loss of 13.4% (13.5 kg) and 15.7% (15.6 kg), respectively, while subjects in the placebo group lost 3.3% (3.2 kg) of their body weight. Eli Lilly and Company has also submitted a marketing application to the FDA for Tirzepatide as a long-term weight management indication.

Eli Lilly's SURMOUNT series of Phase III global clinical development programs for the long-term weight management of Tirzepatide began at the end of 2019, recruiting more than 5,000 obese or overweight patients across six clinical registration studies, four of which are global studies. The primary SURMOUNT-1 study was completed in 2022, and the SURMOUNT-3/-4 studies are expected to be completed in 2023.

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