By Fineline Cube 
U.S. pharmaceutical giant Eli Lilly and Company (NYSE: LLY) has announced positive top-line results from its Phase III ACHIEVE-1 study of orforglipron, an oral small-molecule GLP-1 receptor agonist. The trial evaluated the drug’s safety and efficacy in adults with type 2 diabetes (T2D) who had inadequate glycemic control with diet and exercise alone.
Trial Results
The ACHIEVE-1 study met its primary endpoint, demonstrating superior HbA1c reduction with orforglipron compared to placebo at 40 weeks. Using the efficacy estimand, orforglipron lowered HbA1c by 1.3% to 1.6% from a baseline of 8.0%. A key secondary endpoint saw over 65% of participants on the highest dose achieve an HbA1c level ≤6.5%, below the ADA threshold for diabetes diagnosis. Additionally, participants on the highest dose experienced an average weight loss of 16.0 lbs (7.9% of body weight), with weight loss showing potential for further reduction beyond the study period.
Drug Profile
Orforglipron is the first oral small-molecule GLP-1 receptor agonist to successfully complete a Phase III trial. It offers flexible dosing without restrictions on food or water intake. The drug was discovered by Chugai Pharmaceutical Co., Ltd. and licensed to Lilly in 2018.-Fineline Info & Tech