Eli Lilly, in the race to develop the first major oral GLP‑1 drug for weight loss, says its pill orforglipron will be submitted for approval this year after a Phase 3 study found it delivered double-digit weight loss in people with Type 2 diabetes.
The announcement comes as Eli Lilly concludes a Phase 3 study that found orforglipron delivered "significant weight loss, meaningful A1C reductions, and improvements in cardiometabolic risk factors" after 72 weeks.
Eli Lilly says trial participants who took the highest dose of orforglipron lost an average of 10.5% of their body weight after 72 weeks. Those on lower doses lost between 5.5% and 7.8%. All participants in the study were considered overweight or obese and had Type 2 diabetes.
A similar study on the highest dosage of Zepbound, Eli Lilly's injectable weight loss drug, showed an average weight loss of 12% among people with Type 2 diabetes who were obese or overweight. Among those without diabetes, participants lost an average of 18% of their total body weight.
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"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, Lilly executive vice president. "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."
Currently, GLP-1 drugs to treat obesity and diabetes are injectable. Eli Lilly is among several companies working to create a GLP-1 pill, but oral versions generally have more restrictions than injectable ones. Eli Lilly says it hopes the pill could be available as soon as this year.
According to the Cleveland Clinic, these drugs help manage blood sugar levels by triggering insulin release from the pancreas. The drugs also help slow digestion, which causes less glucose to enter the bloodstream. The medicine also affects satiety, allowing patients to feel full after eating, the Cleveland Clinic said.
