Pharmacokinetic Bioequivalence of Orforglipron Tablets and Capsules in Healthy Participants With Obesity or Overweight

AIMS: To evaluate the bioequivalence of orally administered orforglipron tablets and capsules in participants with obesity or overweight who were otherwise healthy. MATERIALS AND METHODS: ). A prespecified mixed scaling approach was applied to evaluate bioequivalence. Safety and tolerability of the tablets and capsules were also assessed. RESULTS: between each capsule dose and corresponding tablet dose met the predefined criteria for bioequivalence. The safety profiles were similar between tablets and capsules, with no apparent differences or trends in the incidence of treatment-emergent adverse events by presentation or with increasing dose. CONCLUSIONS: Once-daily orforglipron capsules and dose-adjusted tablets demonstrated pharmacokinetic bioequivalence at all tested doses and showed similar safety and tolerability profiles, with mostly mild treatment-emergent adverse events consistent with previous orforglipron clinical trials. CLINICALTRIALS: gov Identifier: NCT06440980.