Eli Lilly And Co.'s (LLY) investigational oral GLP-1 receptor agonist, orforglipron, demonstrated compelling efficacy and a safety profile aligned with that of injectable GLP-1 therapies, according to full Phase 3 results published in The New England Journal of Medicine.
The once-daily pill significantly reduced A1C levels by an average of 1.3% to 1.6% across doses in adults with type 2 diabetes, with improvements observed as early as four weeks. In the ACHIEVE-1 study, a key secondary endpoint showed that orforglipron achieved an average weight loss of 16.0 pounds (7.9%) at the highest dose by week 40. The safety findings were consistent with the broader GLP-1 class profile.
ACHIEVE-1 is a phase 3 trial, which evaluated the safety and efficacy of orforglipron compared to placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. Orforglipron is the first oral small molecule (non-peptide) glucagon-like peptide-1 (GLP-1) receptor agonist, taken without food and water restrictions, to successfully complete a Phase 3 trial.
At 40 weeks, all three doses (3 mg, 12 mg, 36 mg) of orforglipron achieved the primary endpoint of superior A1C reduction. In addition, the 12 mg and 36 mg doses showed clinically meaningful and statistically significant reductions in body weight vs. placebo. In the study, orforglipron had a safety profile similar to the established GLP-1 class, and the most frequently reported adverse events were gastrointestinal-related.
In key secondary endpoints, up to 76.2% of participants taking orforglipron achieved the American Diabetes Association (ADA) treatment target A1C of <7%, 66.0% achieved an A1C of =6.5%, and 25.8% achieved <5.7%, defined as a normal A1C value. Improvements in A1C were observed as early as four weeks and were accompanied by similar reductions in fasting serum glucose, the company said.
Later this year, Lilly plans to share topline results from ACHIEVE-2, evaluating orforglipron compared with dapagliflozin, and ACHIEVE-3, evaluating orforglipron compared to oral semaglutide, both in adults with type 2 diabetes inadequately controlled with metformin. ATTAIN-1 and ATTAIN-2, evaluating orforglipron for weight management, will also be shared in the third quarter of this year.
Lilly said it remains on track to submit orforglipron for weight management to global regulatory agencies by the end of this year and for the treatment of type 2 diabetes in 2026.
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