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A Research Study Comparing the Effect of Different Dosing Conditions on Blood Levels of Semaglutide in a New Tablet Composition in Healthy Participants
Plain-language guide to NCT05996874: phase 1 randomized trial of Semaglutide, 121 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05996874
- Phase
- phase 1
- Status
- completed
- Start
- 2023-08-12
- Completion (planned or actual)
- 2024-04-18
- Participants
- 121 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Healthy Participants
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 1 trial, researchers set out to test Semaglutide.
In this study, a known medicine called 'semaglutide' will be tested in a new tablet version.
The medicine will be tested in healthy men to explore the effect of different water volumes and tablet-meal delays on blood levels of semaglutide after 10 days of oral administration.
Semaglutide tablets, under the brand name Rybelsus, are approved in the EU and USA for the treatment of type 2 diabetes.
It had six arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 121 actual participants took part.
It was open to men only aged from 18 years up to 64 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Body mass index (BMI) between 18.5 and 29.9 kilograms per meter square (kg/m\^2) (both inclusive).
The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: glycated hemoglobin (hba1c) greater than or equal to (\>=) 6.5 percent (%) (48 millimoles per mole \[mmol/mol\]) at screening; use of tobacco and nicotine products, defined as any of the below:; smoking more than 5 cigarettes or the equivalent per day.
How the Study Was Run
Design: randomized, parallel-group and open-label.
The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Being open-label, the Semaglutide study did not mask who received what.
It started in 2023-08-12 with completion listed for 2024-04-18.
It ran at 1 site in Germany.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Semaglutide in 121 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Semaglutide compound page, all human trials.
Our Notes on the Compound
Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.