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A Research Study of How the Medicine NNC0480-0389 Taken With Semaglutide Works in the Body of Healthy Chinese Men
Plain-language guide to NCT05498610: phase 1 randomized trial of Semaglutide, 24 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05498610
- Phase
- phase 1
- Status
- completed
- Start
- 2022-08-11
- Completion (planned or actual)
- 2022-10-12
- Participants
- 24 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 2
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Semaglutide.
NNC0480-0389 is a new medicine that has not been previously approved.
It had three arms (groups): one (experimental), one (experimental) and one (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 24 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: Chinese male participants aged 18-55 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) between 20.0 kg/m\^2 and 27.9 kg/m\^2 (both inclusive). Body weight equal to or greather than 54.0 kg.
The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol; presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
How the Study Was Run
Design: randomized, parallel-group and open-label.
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.
Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2022-08-11 with completion listed for 2022-10-12.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Semaglutide in 24 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.