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16-week Flexible vs. 8-week Semaglutide Titration
Plain-language guide to NCT04447859: phase 3 randomized trial of Semaglutide, 100 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04447859
- Phase
- phase 3
- Status
- status unknown
- Start
- 2020-02-23
- Completion (planned or actual)
- 2022-05-10
- Participants
- 100 (estimated)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes type2
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Semaglutide.
It had two arms (groups): label recommended titration (active comparator) and Slow semaglutide titration (experimental).
The registry classes the interventions as drug and other.
Who Took Part
Enrollment: 100 planned participants were the target.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Have personally signed and dated the informed consent form indicating that he/she has been informed of all pertinent aspects of the trial. Be willing and able to comply with the scheduled visits and other study procedures. Meet one of the following categories:. The subject is a male. Non-hormonal intrauterine device (IUD).
The full record lists 12 inclusion and 5 exclusion criteria; among the exclusions: has a known contraindication to use of glp-1 agonists; has been treated with a glp-1 agonist in the last 30 days; has a history of type 1 diabetes mellitus.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.
The Semaglutide group and the comparison group ran side by side rather than switching.
Being open-label, the Semaglutide study did not mask who received what.
It started in 2020-02-23 with completion listed for 2022-05-10.
It ran at 1 site in Israel.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Gastrointestinal adverse events (GI-AEs) (time frame: 16 weeks - from visit one to visit seven (and in each visit alone)).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Semaglutide in 100 people.
Its status is unknown; 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.