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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: Completed Phase 1 study, sponsored by Novo Nordisk A/S.

NCT05784402 is a Phase 1 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 264 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (340% higher). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Measured in hours\*nanomoles per liter (h\*nmol/L).

Interventions

  • DRUG Semaglutide J
  • DRUG Semaglutide C

Trial Details

FieldValue
Enrollment Target 264 participants
Start Date 2023-03-16
Est. Completion 2024-03-29
Phase Phase 1
Novo Nordisk A/S

431 total trials

What the finished NCT05784402 record still lists

NCT05784402 is an interventional study that assigns participants to a tested intervention. The registered 264 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (340% higher).

The record links to 0 conditions, and to 2 interventions - of which Semaglutide J is the first listed.

NCT05784402 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT05784402's enrollment target sits among peer trials

264 157th of 2000 higher than 1,843 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05784402, the US trial registry maintained by the National Library of Medicine. NCT05784402 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.