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NCT05784402 · ClinicalTrials.gov registry record · Phase 1
A Research Study to Compare How Much Semaglutide is Found in the Blood With Different Tablets of Oral Semaglutide in Healthy Participants
A Phase 1 study, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 1
- Development phase
- 264
- Enrollment target
NCT05784402 is a Phase 1 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 264 participants.
The verdict
NCT05784402, a Phase 1 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 264 participants
- Enrollment target
Study Summary
In this study, a known investigational medicine called 'semaglutide' will be tested in 2 different tablet versions. In addition to semaglutide, the tablet versions contain different helping agents in different amounts. Both tablet versions have a helping agent called SNAC. The main aim of this study is to investigate semaglutide of 4 different doses in a new tablet by determining the amount of semaglutide in the blood and compare the concentration in the blood for the new tablet with the tablet currently investigated in a phase 3b study (current version). For this purpose, the amount of semaglutide in the blood will be measured after multiple doses of semaglutide, at different doses. Which doses participant will get will be decided by chance. The study will have 4 groups (A-D) and will include up to 260 participants. The doses participant get depends on the group they are (enrolled) in. All four groups will be receiving the investigational medicine for 15 weeks in total. Group A will start testing the dose level 1 (new tablet) for 5 weeks. Then receiving the current tablet of semaglutide C for 5 weeks and then testing the dose level 3 (new tablet) for 5 weeks. Group B will start receiving the current tablet semaglutide C for 5 weeks and then testing the dose level 2 (new tablet) in 5 weeks and dose level 4 (new tablet) in 5 weeks. Group C will start testing the dose level 1 (new tablet) and dose level 3 (new tablet) for 5 weeks each and then receiving the current tablet of semaglutide C (2x dose) for 5 weeks. Group D will start testing the dose level 2 (new tablet) for 5 weeks. Then receiving the current tablet of semaglutide C (2x dose) for 5 weeks and then testing the dose level 4 (new tablet) for 5 weeks. Participants will be receiving doses of semaglutide for 6 weeks before being assigned to one of the 4 groups (A-D) to reduce the risk of side effects. Participants cannot choose which group they want to be in, and they can only participate in one group in this s
Interventions
- DRUG Semaglutide J
- DRUG Semaglutide C
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 264 participants |
| Start Date | 2023-03-16 |
| Est. Completion | 2024-03-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05784402
The ClinicalTrials.gov registry entry for NCT05784402 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 264 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Semaglutide J is the first listed.
NCT05784402 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05784402 about?
NCT05784402 is a clinical study titled "A Research Study to Compare How Much Semaglutide is Found in the Blood With Different Tablets of Oral Semaglutide in Healthy Participants". In this study, a known investigational medicine called 'semaglutide' will be tested in 2 different tablet versions. In addition to semaglutide, the tablet versions contain different helping agents in different amounts. Both tablet versions have a helping agent called SNAC. The main aim of this study...
What is the current status of trial NCT05784402?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 264 participants. The study started on 2023-03-16. Estimated completion is 2024-03-29.
What interventions are being tested in trial NCT05784402?
The interventions under investigation include: Semaglutide J (DRUG), Semaglutide C (DRUG).
Who is sponsoring clinical trial NCT05784402?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
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