Eli Lilly has shared positive top-line results from a late-stage study of its investigational oral glucagon-like peptide-1 (GLP-1) receptor agonist as a weight-loss treatment.
The phase 3 ATTAIN-1 trial has been evaluating three once-daily doses of orforglipron in over 3,000 non-diabetic adults who were obese, or overweight with a weight-related medical problem.
All three doses met the primary endpoint and all key secondary endpoints compared to placebo at week 72, with Lilly’s candidate delivering clinically meaningful weight loss when used alongside a healthy diet and physical activity.
The highest dose of 36mg lowered weight by an average of 12.4%, compared to 0.9% with placebo. The middle 12mg dose achieved a 9.3% reduction and patients receiving the lowest 6mg dose saw a 7.8% decrease.
Additionally, 59.6% of patients in the highest dose group lost at least 10% of their body weight, while 39.6% lost at least 15% of their body weight. Among the middle dose group, 45.1% and 24% achieved at least 10% and 15% reductions, respectively. For the low dose cohort, 35.9 % lost at least 10% and 16.5% lost at least 15%.
Orforglipron was also associated with reductions in known markers of cardiovascular risk, and the overall safety profile of the drug was consistent with the established GLP-1 receptor agonist class.
Kenneth Custer, executive vice president and president of Lilly Cardiometabolic Health, said: “With orforglipron, we’re working to transform obesity care by introducing a potential once-daily oral therapy that could support early intervention and long-term disease management, while offering a convenient alternative to injectable treatments.”
Custer added that the company is “planning to submit orforglipron for regulatory review by year-end and [is] prepared for a global launch to address this urgent public health need”.
Discovered by Chugai Pharmaceutical and licensed by Lilly in 2018, orforglipron is designed to stimulate insulin release from the pancreas and slow down the rate at which food travels through the digestive tract, helping patients feel full for longer.
The drug is also being evaluated as a treatment for obstructive sleep apnea and hypertension in adults with obesity.