Eli Lilly announced positive topline results from a phase 3 trial evaluating the safety and efficacy of its oral small molecule glucagon-like peptide-1 (GLP-1) receptor agonist, orforglipron, in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone.
According to Lilly, orforglipron is the first oral GLP-1, taken without food and water restrictions, to successfully complete a phase 3 trial.
In the first phase 3 trial of the ACHIEVE program, orforglipron met the primary endpoint of superior A1C reduction compared to placebo at 40 weeks, lowering A1C by an average of 1.3% to 1.6% across doses. In an additional key secondary endpoint, participants taking orforglipron lost an average of 16 lbs. at the highest dose. 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 overall safety profile of orforglipron was consistent with the established GLP-1 class. The most commonly reported adverse events were gastrointestinal-related and generally mild to moderate in severity.
If approved, Lilly said it is confident in its ability to launch orforglipron worldwide without supply constraints.
The news comes just days after Pfizer said it will discontinue development of its oral GLP-1, danuglipron, after a single participant in one of the dose-optimization studies experienced a potential drug-induced liver injury which resolved after discontinuation of the drug.