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Investigation of Optimal Dosing Conditions for a Long Acting GLP-1 Analogue in Healthy Male Subjects
Plain-language guide to NCT01572753: phase 1 randomized trial of Semaglutide, 161 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01572753
- Phase
- phase 1
- Status
- completed
- Start
- 2012-04-12
- Completion (planned or actual)
- 2012-09-08
- Participants
- 161 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 2; Healthy
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Semaglutide.
This trial is conducted in Europe.
It had eight arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).
The registry classes the interventions as drug.
Who Took Part
161 actual participants took part.
It was open to men only aged from 18 years up to 55 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Good general health as judged by the investigator, based on medical history, physical examination, electrocardiogram (ECG), vital signs and clinical laboratory. Body mass index (BMI) of 18.5-30.0 kg/m\^2 (both inclusive).
The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: history of acute idiopathic or chronic pancreatitis; calcitonin value equal to or above 50 ng/l; subjects who are smokers.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.
It started in 2012-04-12 with completion listed for 2012-09-08.
It ran at 1 site in Germany.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 3 secondary outcomes, for example Cmax; The maximum plasma semaglutide concentration, tmax; Time to maximum plasma semaglutide concentration and t1/2; the terminal half-life of semaglutide.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Semaglutide in 161 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.