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

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).

Timeline

Start

2022-02-04

Primary completion

2023-06-28

Completion

2023-08-08

Publications

• Nielsen MS, Brondsted L, Kankam M, Morelli G, Nguyen D, Skjoth TV, Patted UR, van Hout M. A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants. Diabetes Ther. 2025 Feb;16(2):269-287. doi: 10.1007/s13300-024-01674-8. Epub 2024 Dec 21.

Drugs

Indications