Pharmacokinetic Bioequivalence of Orforglipron Tablets and Capsules in Healthy Participants With Obesity or Overweight
Authors' conclusion
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.
Study context
- Population
- Otherwise healthy adults with obesity or overweight
- Participants
- 429 adults
- Comparison
- Orforglipron capsules vs dose-adjusted tablets
- Outcome
- Steady-state AUC0-24,ss and Cmax,ss
Methodological detailsphase 1, multicenter, open-label, multiple-dose, dose-escalation, prespecified mixed scaling approach
- Phase 1
- Multicenter
- Open-label
- Multiple-dose
- Dose-escalation
- Prespecified mixed scaling approach
Main finding
As reported in the abstract
Bioequivalence (AUC0-24,ss and Cmax,ss)
- Bioequivalence demonstrated between capsules and dose-adjusted tablets across all six doses; 90% CI of geometric least-squares mean ratios of AUC0-24,ss and Cmax,ss met predefined bioequivalence criteria for each dose
Safety
Safety and tolerability
- Similar safety profiles between tablets and capsules; no apparent differences or trends in treatment-emergent AE incidence by presentation or with increasing dose
Original publication
Pharmacokinetic Bioequivalence of Orforglipron Tablets and Capsules in Healthy Participants With Obesity or Overweight. Diabetes Obes Metab. Published 17 April 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →