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Eli Lilly’s Oral Pill Matches Injectable GLP-1 Drugs in Phase 3 Diabetes Trials

Phase 3 data show similar glycemic control to injectables with equivalent weight loss effectiveness, paving the way for an FDA filing by the end of 2025

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Overview

  • Orforglipron’s ACHIEVE-1 trial achieved a 1.3% to 1.6% drop in HbA1c over 40 weeks, aligning with results seen in leading injectable GLP-1 therapies.
  • Patients on the highest dose lost an average of 7.3 kg (7.9%) by week 40, mirroring weight loss outcomes from injectable alternatives.
  • As a non-peptide small molecule, the once-daily pill can be taken without food or water restrictions, offering a more convenient dosing regimen.
  • The safety profile matched existing GLP-1 injectables, with predominantly mild gastrointestinal side effects reported early in treatment.
  • Eli Lilly plans to submit orforglipron for FDA approval by year-end 2025 and aims to make the oral GLP-1 option available in 2026 for diabetes and weight management.