Eli Lilly and Company announced positive topline results from the Phase 3 ACHIEVE-2 and ACHIEVE-5 trials. ACHIEVE-2, the second head-to-head trial in the program, evaluated orforglipron versus dapagliflozin, an SGLT-2 inhibitor, in adults with type 2 diabetes inadequately controlled on metformin. Separately, ACHIEVE-5 assessed orforglipron versus placebo in adults with type 2 diabetes and inadequate glycaemic control with titrated insulin glargine, with or without metformin and/or SGLT-2 inhibitors.
In both trials, orforglipron (3 mg, 12 mg, 36 mg) met the primary and all key secondary endpoints at 40 weeks for both the efficacy and treatment-regimen estimands. The results showed significant A1C reduction and weight loss as well as improvements in multiple cardiovascular risk factors, consistent with previously disclosed studies in type 2 diabetes.
Jeff Emmick, M.D., Ph.D., senior vice president of product development, Lilly Cardiometabolic Health, said: “Orforglipron has now demonstrated superiority over two active comparators in clinical trials for type 2 diabetes. In ACHIEVE-2, orforglipron outperformed dapagliflozin, a commonly used SGLT-2 therapy, and in ACHIEVE-3, showed greater efficacy than oral semaglutide. The findings from ACHIEVE-5 add to this momentum, showing significant A1C reduction and weight loss when used in combination with titrated basal insulin. Together, these results reinforce orforglipron’s potential to become a new standard of care for people living with type 2 diabetes.”
In both trials, the overall safety and tolerability profile of orforglipron, as well as treatment discontinuation rates, were consistent with previous studies. The most common adverse events were gastrointestinal-related and generally mild to moderate in severity. No hepatic safety signal was observed.
The detailed results of these trials will be presented at a future medical meeting and published in a peer-reviewed journal. Results from ACHIEVE-4, the final global registration trial in the ACHIEVE programme, are expected in the first quarter of 2026. Lilly plans to submit orforglipron for the treatment of type 2 diabetes to global regulatory agencies in 2026, while submission for the treatment of obesity is on track to occur by the end of this year.
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