INDIANAPOLIS — Eli Lilly announced that its investigational oral GLP-1 drug, orforglipron, delivered strong results in a Phase 3 trial of people with obesity or overweight and type 2 diabetes.
In the 72-week ATTAIN-2 study, participants taking the highest dose lost an average of 22.9 pounds (10.5%), compared with 5.1 pounds (2.2%) for the placebo group. The drug also cut average A1C levels by up to 1.8%, and 75% of patients on the highest dose reached an A1C of 6.5% or lower — the threshold for diabetes. Beyond weight and glucose, orforglipron improved cholesterol, blood pressure and markers of inflammation.
“Based on my experience leading clinical trials in obesity and diabetes, these data show the potential for orforglipron to offer an efficacy, safety, and tolerability profile consistent with the injectable GLP-1 class,” said Louis J. Aronne, MD, FACP, DABOM, founder and Chair Emeritus of the American Board of Obesity Medicine, former president of The Obesity Society, Fellow of the American College of Physicians, and world-renowned obesity specialist. “Orforglipron could help health care providers expand treatment options for patients who prefer oral therapies without compromising clinical results.”
“The ATTAIN-2 results reinforce the potential for orforglipron, as a once-daily oral, to deliver meaningful weight loss and A1C reduction, consistent with similar landmark trials for injectable GLP-1s,” said Kenneth Custer, Ph.D., Lilly executive vice president and president of Lilly Cardiometabolic Health. “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. If approved, we are ready to offer a convenient, once-daily pill that can be scaled globally — removing barriers and redefining how obesity is treated around the world.”
Orforglipron belongs to the fast-growing GLP-1 class of medicines, which includes injectable drugs like semaglutide (Ozempic, Wegovy). Unlike injectables, it is a once-daily pill that can be taken without food or water restrictions.
Lilly said the safety profile was consistent with other GLP-1 drugs, with the most common side effects being nausea, diarrhea, and other gastrointestinal issues. The company plans to submit the pill for regulatory approval worldwide later this year.
