Lilly’s Oral GLP-1 Orforglipron Shows Superior Results in Two Phase 3 Trials for Type 2 Diabetes | iPharmaCenter

Eli Lilly and Company has announced a major milestone in the development of its oral GLP-1 receptor agonist, orforglipron, following successful results from two large Phase 3 clinical studies—ACHIEVE-2 and ACHIEVE-5. These findings highlight orforglipron’s potential to become a foundational treatment for type 2 diabetes, offering both physicians and patients a new oral option in diabetes care.

Key Study Highlights:

In the ACHIEVE-2 trial, orforglipron lowered average HbA1c (a marker of long-term blood sugar control) by up to 1.7% after 40 weeks, outperforming dapagliflozin (an SGLT-2 inhibitor), which lowered HbA1c by 0.8%. All tested doses of orforglipron met the primary and key secondary endpoints, also delivering notable weight loss and improvements in cardiovascular risk factors.

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The ACHIEVE-5 trial compared orforglipron plus insulin glargine to placebo plus insulin glargine in patients with poorly controlled diabetes. Orforglipron induced up to a 2.1% drop in HbA1c versus a 0.8% reduction in the placebo group, again meeting all major efficacy targets.

In both studies, the safety and tolerability profile of orforglipron was consistent with previous findings; the most common side effects were mild-to-moderate gastrointestinal symptoms, with no liver safety signals observed.

About Orforglipron:

Orforglipron is an investigational, once-daily, non-peptide, oral GLP-1 receptor agonist developed by Chugai Pharmaceutical Co. and licensed by Lilly. Unlike injectable GLP-1 drugs, orforglipron is designed for convenient oral use without food or water restrictions.

Lilly is currently running further global Phase 3 trials, with plans to submit orforglipron for regulatory approval for type 2 diabetes in 2026, and for obesity by the end of 2025.