Oral semaglutide (Rybelsus)

Oral peptide GLP-1 agonist · GLP-1 class · oral peptide · Novo Nordisk

Top dose
25 mg
HbA1c reduction
-1.80%
at week 52 · treatment policy
AE discontinuation
7.0%
Status
approved

Pivotal trial

Trial
PIONEER PLUS
Indication
type 2 diabetes
Duration
52 weeks
ClinicalTrials.gov
NCT04707469
Sponsor
Novo Nordisk

Notes

PIONEER PLUS (Aroda Lancet 2023): oral semaglutide 25 mg HbA1c -1.8% and 50 mg -2.0% vs 14 mg -1.5%, baseline 9.0%. Higher doses (25/50 mg) approved 2025. Requires fasting administration.

Publication

Lancet 2023 (PIONEER PLUS)