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Eli Lilly and Company announced Tuesday that it will seek global regulatory approval for its new weight-loss and diabetes drug, orforglipron, after positive late-stage trial results. Orforglipron is a pill form of the popular GLP-1 class of medications, currently only available as injectables such as Lilly’s Mounjaro and Trulicity for diabetes and Zepbound for obesity.
The trial results, while not yet peer-reviewed or published, indicate that orforglipron is both safe and effective. Participants with overweight, obesity, and type 2 diabetes lost an average of 10.5% of their body weight (22.9 pounds) after taking the highest dose (36 mg) daily for 72 weeks. The drug also significantly improved blood sugar control, lowering A1C levels by an average of 1.8%.
The most commonly reported side effect was an upset stomach, generally mild to moderate in severity, mirroring side effects seen with injectable GLP-1 drugs.
This announcement comes as Novo Nordisk also awaits FDA decision on its own oral GLP-1 drug for weight loss. Currently, the only available oral semaglutide, Rybelsus, is limited to treating type 2 diabetes and requires strict dietary restrictions. Orforglipron does not have these limitations.
The development of a GLP-1 pill is a significant step forward, as injectables, while effective, can be inconvenient due to refrigeration requirements, higher production costs, and patient aversion to needles. Lilly, anticipating high demand, has already begun mass production of orforglipron.
The company also plans to publish the full trial results in a peer-reviewed journal and explore the drug’s potential for treating high blood pressure and sleep apnea. Some experts suggest the pill form could serve as a maintenance option after patients achieve desired results with injectables.