Two more phase 3 wins for orforglipron in type 2 diabetes

Eli Lilly reported on October 15, 2025, that its experimental oral GLP-1 drug, orforglipron, met its main goals in two more Phase 3 trials for type 2 diabetes, adding to a growing package of data the company plans to file with regulators in 2026 ^[1]. Orforglipron is a once-daily pill, not an injection like Ozempic or Mounjaro, and it does not yet have a brand name for this use ^[1].

In the first trial, called ACHIEVE-2, researchers gave 962 adults with type 2 diabetes either orforglipron or dapagliflozin (Farxiga), a common SGLT-2 inhibitor pill, on top of metformin ^[1]. Starting from an average A1C of 8.1%, orforglipron lowered blood sugar by 1.3% to 1.7%, depending on the dose, compared with a 0.8% drop for dapagliflozin ^[1][2]. All three orforglipron doses beat dapagliflozin by a statistically significant margin ^[1].

The second trial, ACHIEVE-5, tested orforglipron in 546 adults whose diabetes was not controlled by insulin glargine, with or without metformin or an SGLT-2 drug ^[1]. Starting from a higher average A1C of 8.5%, orforglipron lowered blood sugar by 1.5% to 2.1%, versus 0.8% for placebo, again meeting the study's main goal ^[1][2]. Lilly said patients in both trials also lost weight and saw improvements in several heart-related risk factors, though the company did not release specific weight-loss figures for these two trials ^[1].

The most common side effects were stomach and digestive problems, described as generally mild to moderate, and the company said it saw no signal of liver damage ^[1]. Lilly said the safety profile and the rate at which patients dropped out of the studies were similar to earlier orforglipron trials ^[1]. In an earlier head-to-head trial, ACHIEVE-3, orforglipron also outperformed Rybelsus, Novo Nordisk's oral semaglutide pill, on blood sugar and weight measures ^[2].

Why it matters for patients

These results matter because they show orforglipron working not just against a placebo, but against two treatments doctors already prescribe: an SGLT-2 pill and insulin ^[1][2]. For people who take multiple medications to manage type 2 diabetes, evidence that a single daily pill can outperform or add to those existing options could eventually change how doctors think about treatment order. Because orforglipron is a pill rather than an injection, it could also appeal to patients who want to avoid needles, if it is approved.

Still, this is not yet an approved medicine. The company has released only topline numbers so far; full results have not yet been presented at a medical meeting or published in a peer-reviewed journal, so independent experts have not yet reviewed the complete data ^[1]. Reuters noted the drug still needs approval from the Food and Drug Administration before it can reach patients ^[2].

What happens next

Lilly said results from ACHIEVE-4, the final trial in its five-study registration program for type 2 diabetes, are expected in the first quarter of 2026 ^[1]. The company said it plans to submit orforglipron to global regulators for type 2 diabetes sometime in 2026, while a separate submission for obesity treatment is expected by the end of 2025 ^[1][2]. The overall ACHIEVE program has enrolled more than 6,000 people with type 2 diabetes since it began in 2023 ^[1]. Until the FDA reviews the full data and makes a decision, orforglipron remains investigational and is not available by prescription ^[1][2].