After a successful third phase 3 trial for its oral GLP-1 drug orforglipron, Eli Lilly says it has the full clinical data package required to initiate global regulatory submissions and bring to market a once-daily pill to treat obesity.
“With these positive data in hand, we are moving with urgency toward global regulatory submissions to potentially meet the needs of patients who are waiting,” said Kenneth Custer, Ph.D., Lilly executive vice president and president of Lilly Cardiometabolic Health.
Orforglipron is an investigational oral GLP-1 receptor agonist with a similar efficacy and safety profile to injectable GLP-1 therapies.
The phase 3 ATTAIN-2 trial assessed orforglipron in adults with obesity or overweight with type 2 diabetes. Orforglipron met the primary endpoint, reducing weight by an average of 10.5% (22.9 lbs) when taken at the highest dose of 36 mg without food or water restrictions. This was compared to a weight loss of 2.2% (5.1 lbs) with the placebo. The drug also met all the key secondary endpoints, including lowering A1C on all doses by 1.3% to 1.8% from a baseline of 8.1%. It also achieved improved cardiometabolic risk factors at 72 weeks.
Earlier this month, Lilly reported positive results for its first phase 3 trial, ATTAIN-1, which achieved an average weight loss of 12.4% (27.3 lbs) in patients without diabetes.