Study S002083

A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

Included trial: extracted data ClinicalTrials.gov record

Registration

Registration: NCT05227196
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 546
Start: 2022-02-04
Primary completion: 2023-06-28
Lead sponsor: Novo Nordisk A/S
Conditions: Healthy Volunteers; Type 2 Diabetes
Interventions: DRUG:Semaglutide D Dose 1; DRUG:Semaglutide D Dose 2; DRUG:Semaglutide D Dose 3; DRUG:Semaglutide Dose 4; DRUG:Semaglutide Dose 5; DRUG:Semaglutide Dose 6
Results posted: FALSE
Individual participant data sharing: YES

Registered primary outcomes

AUC0-24h,semaglutide,SS Area under the semaglutide plasma concentration-time curve during a dosing interval at steady state (SS) [24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.]
Cmax,0-24h.semaglutide,SS Maximum semaglutide plasma concentration at steady state [24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0013595	A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants. Nielsen MS, Diabetes therapy : research, treatment and education of diabetes and related disorders	2025	Randomized trial	PMID 39708086 DOI	cites ClinicalTrials.gov:NCT05227196; registry reference DERIVED:39708086