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Lilly Says Oral GLP-1 Pill Is Ready for Global Filings After Late-Stage Results

Peer-reviewed publication remains pending ahead of regulatory review.

Eli Lilly Biotechnology Center is shown in San Diego, California, U.S. March 1, 2023. REUTERS/Mike Blake/File Photo
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Overview

  • At the top 36 mg dose, participants lost an average of 22.9 pounds, or 10.5% of body weight, after 72 weeks of once-daily orforglipron.
  • The trial also showed an average A1C reduction of 1.8% in people with type 2 diabetes.
  • Reported side effects were generally mild to moderate and similar to injectable GLP-1s, with upset stomach most commonly noted.
  • Lilly has already begun mass production of orforglipron tablets to prepare for potential demand.
  • The pill would enter a crowded field that includes Novo Nordisk’s oral Wegovy under FDA review and offers dosing without the fasting restrictions of Rybelsus.