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Phase 3 Trials Show Greater Weight Loss With 7.2 mg Injection and 25 mg Oral Semaglutide

Regulators are assessing new dosing options following trial results showing greater weight loss with added side effects.

Overview

  • A once-daily 25 mg oral semaglutide pill produced a mean 13.6% weight reduction versus placebo in a 64–71 week trial, with 16.6% average loss among adherent participants and 34.4% achieving at least 20% weight loss.
  • In adults with obesity and type 2 diabetes, a 7.2 mg weekly injection cut body weight by 13.2% over 72 weeks versus 10.4% with the approved 2.4 mg dose and 3.9% with placebo, and delivered larger waist reductions.
  • Gastrointestinal symptoms were frequent with the oral pill (74% versus 42.2% on placebo), while the 7.2 mg injection showed higher dysesthesia rates (18.9% versus 4.9% at 2.4 mg) and more dose reductions, with one death possibly related to the drug.
  • Novo Nordisk has filed a U.S. application for the oral formulation, with an FDA decision expected by year-end 2025, and says a pill could broaden access for patients who avoid injections or lack refrigeration.
  • Both studies were company-funded; the oral trial excluded people with diabetes, and independent experts are calling for longer-term safety data and clearer measures of fat versus lean mass changes.