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A Clinical Trial Comparing Semaglutide in Healthy People Who Eat and Take the Medicine at Different Times
Plain-language guide to NCT04513704: phase 1 randomized trial of Semaglutide, 156 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04513704
- Phase
- phase 1
- Status
- completed
- Start
- 2020-08-28
- Completion (planned or actual)
- 2021-04-20
- Participants
- 156 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Healthy Volunteers Type 2 Diabetes
- 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.
Participants with type 2 diabetes are recommended to take semaglutide on an empty stomach, and they should not eat, drink, or take any oral medicine for at least 30 minutes after that.
It had five arms (groups): Oral Semaglutide A (experimental), Oral Semaglutide B (experimental), Oral Semaglutide C (experimental), Oral Semaglutide D (experimental) and Oral Semaglutide E (active comparator).
The registry classes the interventions as drug.
Who Took Part
156 actual participants took part.
It was open to people of any sex aged from 18 years up to 64 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Male or female, aged 18-64 years (both inclusive) at time of signing informed consent. Body mass index (BMI) between 20.0 and 29.9 kg/m\^2 (both inclusive).
The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: use of tobacco and nicotine products, defined as any of the below:; smoking more than 5 cigarettes or the equivalent per day; not willing to refrain from smoking and use of nicotine substitute products during the in-house period.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.
The Semaglutide group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.
It started in 2020-08-28 with completion listed for 2021-04-20.
It ran at 1 site in United Kingdom.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Semaglutide in 156 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.