Eli Lilly has asked the Food and Drug Administration to approve orforglipron after completing a Phase 3 trial showing it helped people maintain weight loss after stopping injectable drugs such as Wegovy and Zepbound.
The request follows another Phase 3 trial indicating the drug produced double-digit weight loss in people with Type 2 diabetes.
Currently, GLP-1 drugs used to treat obesity and diabetes are injectable. Eli Lilly is among several companies developing an oral GLP-1 medication, though pill versions typically have more restrictions than injections. Lilly says orforglipron could be a more convenient alternative.
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“Obesity is a chronic, progressive disease, and sustaining weight loss remains a significant challenge for many,” said Kenneth Custer, executive vice president and president of Lilly Cardiometabolic Health. He said the medication “helped people maintain the weight they worked hard to lose” and allowed patients “to switch directly from the highest tolerated doses of available injectable therapies onto oral doses of orforglipron.”
In the latest study, participants who had used Wegovy lost an average of 41 pounds. After a year on orforglipron, they regained about 2 pounds. Participants who used Zepbound lost an average of 55 pounds, and those who switched to orforglipron regained 11 pounds over the same period.
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Lilly says the pill helped participants keep more weight off compared to those taking a placebo, even with similar diet and exercise counseling.
In an earlier study involving people with Type 2 diabetes, participants taking 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 were considered overweight or obese and had Type 2 diabetes.
