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Eli Lilly's Oral GLP-1 Pill Demonstrates Success in Phase 3 Trials

The first nonpeptide oral GLP-1 therapy, orforglipron, matches injectable drugs in weight-loss and glucose-control efficacy, with FDA filings planned for late 2025.

An Eli Lilly and Company pharmaceutical manufacturing plant is pictured at 50 ImClone Drive in Branchburg, New Jersey, March 5, 2021.
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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)

Overview

  • Orforglipron reduced A1C levels by up to 1.6% and achieved an average 7.9% weight loss in Type 2 diabetes patients over 40 weeks.
  • Over 65% of participants on the highest dose reached A1C levels at or below 6.5%, considered below the diabetic threshold.
  • The safety profile was consistent with injectable GLP-1 drugs, with mild to moderate gastrointestinal side effects reported.
  • Eli Lilly plans to file for regulatory approval for obesity treatment by the end of 2025 and for diabetes management in 2026.
  • If approved, orforglipron could simplify treatment accessibility and manufacturing, addressing global demand for diabetes and obesity therapies.