← Human Trials & Peer-Reviewed Studies
A Trial Investigating the Influence of Oral Semaglutide on the Pharmacokinetics of Lisinopril and Warfarin in Healthy Subjects
Plain-language guide to NCT02070510: phase 1 non-randomized trial of Semaglutide, 52 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02070510
- Phase
- phase 1
- Status
- completed
- Start
- 2014-02-27
- Completion (planned or actual)
- 2014-08-20
- Participants
- 52 (actual)
- Design
- non-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
This registered phase 1 trial tested Semaglutide.
This trial is conducted in Europe.
It had 1 arm (groups): Victim and perpetrator compounds (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 52 actual participants took part.
It was open to people of any sex aged from 18 years up to 75 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Male or female aged 18-75 years (both inclusive) at time of signing informed consent. Body mass index 20.0-29.9 kg/m\^2 (both inclusive). A good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator.
The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: history of crohn's disease, ulcerative colitis, or other inflammatory bowel disease.
How the Study Was Run
The set-up was non-randomized, crossover and open-label.
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 2014-02-27 with completion listed for 2014-08-20.
It ran at 1 site in Germany.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Area under the S-warfarin concentration-time curve. Area under the R-warfarin concentration-time curve. Area under the lisinopril concentration-time curve.
It also tracked 3 secondary outcomes, for example Maximum observed S-warfarin plasma concentration, Maximum observed R-warfarin plasma concentration and Maximum observed lisinopril plasma concentration.
What This Means in Plain Language
Put simply, this is a phase 1, non-randomized trial of Semaglutide in 52 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.