US major Eli Lilly (NYSE: LLY) has announced that the Phase III SURMOUNT-CN study for its glucose-dependent insulinotropic polyptide (GIP)/glucagon-like peptide-1 (GLP-1) receptor agonist tirzepatide has reached the primary endpoint and all pivotal secondary endpoints in obese or overweight Chinese adults. The study demonstrated that the overall safety profile was similar to that of previous tests, with no new safety signals identified.
Study Design and Results
The randomized, double-blind, placebo-controlled Phase III clinical study was designed to assess the efficacy and safety of tirzepatide administered once per week in obese or overweight Chinese adults without type 2 diabetes. The study enrolled 210 subjects, with the primary endpoint being the average percentage of weight change and the percentage of subjects achieving weight loss of ≥5%. The results showed significant efficacy in weight management, aligning with the study’s objectives.
Global Approvals and Research Data
Tirzepatide obtained market approval in the US in May 2022 for improving blood sugar control (based on diet and exercise) in type 2 diabetics. It became the world’s first once-daily GIP/GLP-1 receptor agonist and subsequently gained market approvals in the EU and Japan. Research data has shown that tirzepatide can significantly reduce glycosylated hemoglobin (HbA1c) levels and body weight in patients, while also reducing gastrointestinal side effects and improving biomarkers related to nonalcoholic steatohepatitis (NASH).-Fineline Info & Tech