Lilly Reports Positive Phase III Results for Orforglipron, Targeting 2025–2026 Approvals

Eli Lilly has announced strong Phase III results for its oral GLP-1 receptor agonist, orforglipron, reinforcing its plans to seek approval for obesity by end-2025 and type 2 diabetes in 2026. The latest data from the ACHIEVE-2 and ACHIEVE-5 trials showed that orforglipron met all primary and key secondary endpoints.

In ACHIEVE-2, orforglipron outperformed dapagliflozin (Farxiga) across three doses (3 mg, 12 mg, 16 mg), reducing A1C by 1.3%, 1.7%, and 1.7%, versus 0.8% with dapagliflozin. ACHIEVE-5, comparing orforglipron to placebo, showed A1C reductions of 1.5%, 2.1%, and 1.9% across dose levels. Both studies demonstrated significant weight loss and improvements in cardiovascular risk factors, with safety consistent with prior trials.

Combined with earlier ACHIEVE-3 and ATTAIN data, the findings position orforglipron as a potential new standard of care in type 2 diabetes. Analysts forecast global sales of $11 billion by 2031, as Lilly competes closely with Novo Nordisk’s Rybelsus (oral semaglutide).

19-10-2025