Lilly ready to file for approval of oral GLP-1 orforglipron

US pharma major Eli Lilly’s (NYSE: LLY) shares rose 2.6% to $713.69 in early trading today, after it released positive top-line results from the Phase III ATTAIN-2 trial, evaluating orforglipron, an investigational oral GLP-1 receptor agonist, in adults with obesity or overweight and type 2 diabetes.

In the trial, all three doses of orforglipron met the primary and all key secondary endpoints, delivering significant weight loss, meaningful A1C reductions, and improvements in cardiometabolic risk factors at 72 weeks. For the primary endpoint, orforglipron 36mg, taken once per day without food and water restrictions, lowered weight by an average of 10.5% (22.9 lbs) compared to 2.2% (5.1 lbs) with placebo using the efficacy estimand.

With the completion of ATTAIN-2, Lilly said that it now has the full clinical data package required to initiate global regulatory submissions for orforglipron.