Eli Lilly (LLY.US) announced Wednesday that its oral weight loss candidate drug, orforglipron, has met its primary endpoints in two Phase III clinical trials involving patients with type 2 diabetes, highlighting the drug's potential in blood sugar control. The Indiana-based pharmaceutical company indicated that, based on the results of the ACHIEVE-2 and ACHIEVE-5 trials, the once-daily GLP-1 receptor agonist orforglipron is poised to become a new standard in type 2 diabetes treatment. Preliminary results show that the ACHIEVE-2 trial achieved its primary endpoint, with orforglipron reducing the diabetes biomarker hemoglobin A1C levels by up to 1.7%, compared to a 0.8% reduction with AstraZeneca's (AZN.US) Farxiga. The ACHIEVE-5 trial also reached its primary endpoint, with orforglipron combined with insulin glargine further lowering hemoglobin A1C levels by 2.1%.

As the second head-to-head study in the company's ACHIEVE clinical trial program, ACHIEVE-2 enrolled adult patients with type 2 diabetes who had poor blood sugar control after treatment with metformin, while ACHIEVE-5 targeted similar patients with inadequate control using insulin glargine. Both 40-week studies tested three doses: 3mg, 12mg, and 36mg. Eli Lilly further noted that both trials gathered safety and tolerability data, and the drug's treatment interruption rates aligned with prior trial data. The final global registration trial of the ACHIEVE program is expected to report results in the first quarter of 2026, and the company plans to seek global regulatory approval for orforglipron's type 2 diabetes indication next year. Additionally, Eli Lilly reiterated its intention to submit approval data for the drug's use in obesity treatment by the end of 2025.