Eli Lilly plans to seek FDA approval for its once daily GLP-1 pill – the oral version of its Zepbound and Mounjaro – after the success of its phase 3 clinical trial for the oral form of the diabetes and weight-loss medication.
The trial of the drug, orforglipron, measured its efficacy and safety in adults with type 2 diabetes compared with a placebo, and found the pill lowered A1C, a blood level used to diagnose diabetes, by an average of 1.3% to 1.6%, across different doses, after 40 weeks.
Participants taking the highest dose also lost an average of 7.2kg, reports CBS.
“Given that participants had not yet reached a weight plateau at the time the study ended, it appears that full weight reduction was not yet attained,” the company said in a news release. It did not include information on the demographics of the people who participated in the trial.
The most commonly reported adverse effects were mild to moderate gastrointestinal issues, including diarrhoea, nausea, indigestion, constipation and vomiting.
The pill, which would offer an alternative to injections, is the first small molecule oral GLP-1 to succeed in a phase 3 trial, the company said.
Eli Lilly plans to submit orforglipron to the FDA for approval as a type 2 diabetes treatment in 2026.
For weight management, it plans to submit the drug to global regulatory agencies by the end of this year.
“If approved, the company plans…. to launch orforglipron worldwide without supply constraints, furthering Lilly’s mission to reduce chronic diseases like type 2 diabetes, which is expected to affect an estimated 760m adults by 2050,” the company said.
Dr Louis Aronne, director of the Comprehensive Weight Control Centre at Weill Cornell Medicine, described the new drug as “transformational”.
Just think about having a pill that can be distributed anywhere in the world, that doesn’t need to be refrigerated, Aronne told CBS. “It’s as effective as the injectable semaglutide. That is a big deal.”
See more from MedicalBrief archives:
Zepbound slashes diabetes risk by 94% – Eli Lilly
Eli Lilly slashes insulin prices by 70%
WHO warning about weight-loss drugs as obesity guidelines amended