India Pharma Outlook Team | Friday, 19 September 2025
Eli Lilly and Company announced promising topline findings from its ACHIEVE-3 Phase 3 study, revealing that their investigational GLP-1 receptor agonist, orforglipron, which is administered orally once a day, was associated with better results than oral semaglutide in adults with type 2 diabetes whose blood sugar was inadequately controlled on metformin.
This 52-week randomized trial involved 1,698 participants from the United States, Asia, and Latin America directly comparing orforglipron at both 12 mg and 36 mg doses to oral semaglutide at both 7 mg and 14 mg doses.
The trial demonstrated that orforglipron met all primary and key secondary endpoints, with greater reductions in A1C and weight loss than semaglutide. At week 52, orforglipron reduced A1C by 1.9% (12 mg) and 2.2% (36 mg) while the reductions for semaglutide were 1.1% and 1.4%, respectively.
Also Read: Oral GLP-1 Drugs: Expanding Patient Access in Obesity and Diabetes Care
Notably, nearly three times as many patients achieved background levels of blood sugar on the highest dose of orforglipron compared to the highest dose of semaglutide. Weight loss results also favored Lilly's treatment, with patients on orforglipron losing up to 19.7 lbs (9.2%) compared to 11 lbs (5.3%) on semaglutide.
The therapy also produced improvements in cardiovascular risk factors, including cholesterol, blood pressure, and triglycerides. Safety findings were consistent with previous trials, and gastrointestinal events were the most prevalent but were slightly higher for orforglipron for discontinuation rates.
Lilly intends to submit global regulatory submissions for orforglipron in 2026, making it a candidate to become a next generation oral therapy for type 2 diabetes. The ACHIEVE Phase 3 program involves more than 6,000 patients globally and is expected to generate additional data throughout 2026.
