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Pharmacoscintigraphic Investigation of NN9924 in Healthy Male Subjects
Plain-language guide to NCT01619345: phase 1 randomized trial of Semaglutide, 27 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01619345
- Phase
- phase 1
- Status
- completed
- Start
- 2012-06
- Completion (planned or actual)
- 2012-08
- Participants
- 27 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Healthy
- 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.
This trial is conducted in Europe.
The aim of this trial is to investigate whether the volume of water administered with NN9924 affects the anatomical location (stomach or proximal small bowel) of tablet erosion.
It had two arms (groups): one (experimental) and one (experimental).
The registry classes the interventions as drug.
Who Took Part
27 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: Good general health. Body mass index (BMI) of 18.5-30.0 kg/m\^2 (both inclusive).
The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: participation in another clinical trial within 90 days; any chronic disorder or severe disease; subjects who are smokers.
How the Study Was Run
The set-up was randomized, crossover and open-label.
Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.
Each person switched between Semaglutide and the comparison at some point, usually with a gap in between.
Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.
It started in 2012-06 with completion listed for 2012-08.
It ran at 1 site in United Kingdom.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Anatomical location (stomach or proximal small bowel) of tablet at complete tablet erosion (CTE).
It also tracked 4 secondary outcomes, for example Area under the NN9924 concentration curve, Anatomical location of initial tablet erosion (ITE), Time to ITE and Time to CTE.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Semaglutide in 27 people.
Its size is small, so on its own it can only give an early look.
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.