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Eli Lilly's Oral GLP-1 Pill Achieves Key Milestone in Diabetes and Weight Loss Treatment

Orforglipron, a once-daily oral therapy, shows significant blood sugar and weight reduction in Phase 3 trial, paving the way for regulatory submissions in 2025 and 2026.

An Eli Lilly and Company pharmaceutical manufacturing plant is pictured at 50 ImClone Drive in Branchburg, New Jersey, March 5, 2021.
INDIANAPOLIS, INDIANA - MARCH 17: A flag flies above the headquarters campus of Eli Lilly and Company on March 17, 2024 in Indianapolis, Indiana. Lilly, a pharmaceutical company, employs more than 12.000 people in Indianapolis and more than 42,000 worldwide. (Photo by Scott Olson/Getty Images)
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Overview

  • The ACHIEVE-1 Phase 3 trial demonstrated that orforglipron reduced HbA1c levels by 1.3% to 1.6% and body weight by up to 7.9% over 40 weeks in adults with type 2 diabetes.
  • More than 65% of participants on the highest dose achieved HbA1c levels of 6.5% or less, a key diabetes control benchmark.
  • Orforglipron is the first oral small-molecule GLP-1 therapy to complete a Phase 3 trial without food or water restrictions, offering a needle-free alternative to injectable treatments.
  • The safety profile was consistent with other GLP-1 therapies, with common side effects including nausea, diarrhea, and vomiting, leading to treatment discontinuation rates of 4%–8%.
  • Eli Lilly plans to seek regulatory approval for obesity treatment by the end of 2025 and for type 2 diabetes in 2026, with additional data presentations expected later this year.