India Pharma Outlook Team | Tuesday, 21 October 2025
Eli Lilly and Company has announced strong Phase 3 data for its investigational oral GLP-1 therapy Orforglipron from ACHIEVE-2 and ACHIEVE-5 trials, which could potentially lay the groundwork for a new treatment standard in type 2 diabetes.
In the ACHIEVE-2 trial, Orforglipron was tested head-to-head against dapagliflozin (an SGLT-2 inhibitor) in adults with type 2 diabetes who remained uncontrolled on metformin.
All primary and key secondary endpoints were achieved at week 40, with both A1C reduction and meaningful weight loss significantly greater with Orforglipron versus dapagliflozin based on every assessed outcome.
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The ACHIEVE-5 trial compared Orforglipron with placebo in adults with type 2 diabetes who were using titrated basal insulin. Here, Orforglipron also achieved all endpoints at week 40, boosting A1C, weight, and cardiovascular risk improvement in all three doses (3 mg, 12 mg, and 36 mg) tested.
Dr. Jeff Emmick, Senior Vice President of Product Development at Lilly Cardiometabolic Health, stated that Orforglipron runs superior to the comparison groups, dapagliflozin and oral semaglutide, as the potential new first-line treatment for people living with type 2 diabetes.
From an industry perspective, the findings are quite remarkable. An oral GLP-1 treatment that has similar or better glucose and weight control capabilities than currently available injectables could change the entire landscape of diabetes care, especially within primary care.
The safety profile remained consistent with previous studies where most adverse events were mild to moderate gastrointestinal events and there were no hepatic safety signal concerns.
Eli Lilly intends to submit Orforglipron for regulatory approval by 2026 for t2DM, and could potentially submit for obesity before the end of this year. Final results from Phase 3 ACHIEVE-4 study will be in early 2026.
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