A phase 1, randomized, double‐blind, placebo‐controlled trial investigating the pharmacokinetics, pharmacodynamics, safety and tolerability of oral semaglutide in healthy Chinese subjects
Authors' conclusion
At steady state, oral semaglutide exposure was dose dependent and close to dose proportionality in healthy Chinese subjects. This is consistent with previous clinical pharmacology results for oral semaglutide.
Study context
- Population
- Healthy Chinese adults
- Participants
- 32 adults
- Comparison
- Once-daily oral semaglutide vs placebo for 12 weeks
- Primary endpoint
- AUC of semaglutide concentration-time curve over a dosing interval (0-24 h) at steady state (AUC0-24h,sema,SS)
- Follow-up
- Steady state
Methodological detailsphase 1, double-blind, placebo-controlled, single-centre, multiple-dose
- Phase 1
- Double-blind
- Placebo-controlled
- Single-centre
- Multiple-dose
Primary result
As reported in the abstract
AUC0-24h,sema,SS
AUC0-24h,sema,SS, 3 mg
233 h·nmol/L
AUC0-24h,sema,SS, 7 mg
552 h·nmol/L
AUC0-24h,sema,SS, 14 mg
1288 h·nmol/L
Further findings
| Outcome | P value |
|---|---|
| Body weight · end of treatmentSignificant reduction with oral semaglutide | P = 0.0001 |
| FPG · end of treatmentSignificant reduction with oral semaglutide | P = 0.0011 |
Cmax,sema,SS · steady state
- Dose-dependent increases in Cmax,sema,SS
Safety
Safety and tolerability
- Severe or blood-glucose-confirmed symptomatic hypoglycaemic events
- 0
- Serious adverse events
- 0
- Deaths
- 0
- Consistent with known GLP-1 RA profile
- Most frequent adverse events were gastrointestinal disorders
Original publication
A phase 1, randomized, double‐blind, placebo‐controlled trial investigating the pharmacokinetics, pharmacodynamics, safety and tolerability of oral semaglutide in healthy Chinese subjects. Diabetes Obes Metab. Published 29 May 2024. doi:10.
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