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
Outcome
Met primary endpoint
paper The prespecified EMA, FDA and PMDA bioequivalence criteria were met for 2G versus 1G oral semaglutide for all three dose levels PMID 39708086 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Semaglutide | Peptide | 1.5 mg | Oral |
| Subject | Semaglutide | Peptide | 3 mg | Oral |
| Subject | Semaglutide | Peptide | 4 mg | Oral |
| Subject | Semaglutide | Peptide | 7 mg | Oral |
| Subject | Semaglutide | Peptide | 9 mg | Oral |
| Subject | Semaglutide | Peptide | 14 mg | Oral |