Orforglipron: Phase 3 Data Shows Ozempic-Like Results, In Pill Form

Eli Lilly’s oral GLP-1 candidate orforglipron met all primary and secondary endpoints in a Phase 3 study of adults with type 2 diabetes, the company announced Thursday. At the highest dose, participants lost 7.9 percent of their body weight over 40 weeks, with A1C reductions reaching as much as 1.6 percentage points.

These numbers are exactly what Lilly was looking for.

Lilly plans to submit orforglipron for FDA approval after its obesity focused Phase 3 trials conclude later this year. The drug has already been granted priority review, positioning it for a potential regulatory decision by mid 2026. That timeline could shift if the agency experiences further internal disruption, but Lilly has already begun manufacturing at scale.

The update places Lilly in a commanding position in the oral GLP-1 race. Novo Nordisk’s oral semaglutide program has technically shown similar efficacy at very high doses. In the PIONEER PLUS trial, 25 and 50 milligram versions of Rybelsus led to body weight reductions of 7.3 and 8.5 percent, respectively. But those doses required such a large volume of semaglutide that Novo has slow walked its potential launch. Industry observers widely believe the company is rationing its active pharmaceutical ingredient to maintain global supply of the injectable versions, particularly Ozempic and Wegovy, which remain constrained.

By contrast, orforglipron is a small molecule. It does not rely on peptide synthesis, cold chain logistics, or acid blockers. It can be produced more efficiently, stored more easily, and scaled to meet demand without drawing from the same supply pool as injectables.

This differentiation becomes even more significant in the wake of Pfizer’s withdrawal from the oral small-molecule GLP-1 space. Just last week, Pfizer announced it had ended development of danuglipron following a case of liver injury during long term use. Danuglipron had once been considered a potential competitor to orforglipron. That window has closed.

The population in Lilly’s latest trial consisted of adults with type 2 diabetes, a group that historically sees less weight loss than those without. Results from orforglipron’s obesity specific trials, which are expected sometime in July of 2025, will offer a more complete view of the drug’s potential. Phase 2 studies in people without diabetes showed double digit weight loss.

Lilly now stands alone with a viable oral GLP-1 candidate in late stage development. Obesity results are on deck. Manufacturing is in place. Millions of dollars in inventory have already been produced. Orforglipron may become the first oral obesity drug to rival injectables in both efficacy and scalability.