NCT05227196

A Research Study Looking at the Comparability of 2 Different Forms of Oral Semaglutide in Healthy People

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 546 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood in two different tablet versions of Semaglutide. The study will consist of 3 groups and the treatment the participants will get is dependent on the group the participants will be enrolled in. The participants in group 1 will receive treatment for 22 weeks, group 2 for 21 weeks and group 3 for 20 weeks. The study will last up to 29 to 31 weeks for each participant. This includes a screening period (up to 4 weeks), a dose escalation period (up to 2 weeks), a treatment period (20 weeks) and a follow-up period (5 weeks after the last dose).

Conditions

• Healthy Volunteers
• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Semaglutide D Dose 1	Tablet given orally
DRUG	Semaglutide D Dose 2	Tablet given orally
DRUG	Semaglutide D Dose 3	Tablet given orally
DRUG	Semaglutide Dose 4	Tablet given orally
DRUG	Semaglutide Dose 5	Tablet given orally
DRUG	Semaglutide Dose 6	Tablet given orally

Timeline

• Start date: 2022-02-04
• Primary completion: 2023-06-28
• Completion: 2023-08-08
• First posted: 2022-02-07
• Last updated: 2024-09-19

Locations

3 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study