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A Research Study Investigating How Semaglutide and Dapagliflozin Act in Your Body When Dosed in One Tablet
Plain-language guide to NCT05429593: phase 1 randomized trial of Semaglutide, 152 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05429593
- Phase
- phase 1
- Status
- completed
- Start
- 2022-06-22
- Completion (planned or actual)
- 2023-03-10
- Participants
- 152 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Healthy Volunteers
- 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 will take part in either part 1 or part 2.
It had four arms (groups): Part 1 sequence A (experimental), Part 1 sequence B (experimental), Part 2 sequence A (experimental) and Part 2 sequence B (experimental).
Semaglutide followed by Semaglutide/dapagliflozin.
Semaglutide/dapagliflozin followed by Semaglutide.
Dapagliflozin followed by Semaglutide/dapagliflozin.
The registry classes the interventions as drug.
Who Took Part
The registry lists 152 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 the time of signing informed consent. Body mass index between 20.0 and 29.9 kg/m\^2 (both inclusive).
The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol; 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, crossover and open-label.
The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.
In the crossover set-up each of the participants took both Semaglutide and the comparison in turn, acting as their own control.
Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.
It started in 2022-06-22 with completion listed for 2023-03-10.
It ran at 2 sites in Germany (2).
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Semaglutide in 152 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.