← Human Trials & Peer-Reviewed Studies
Effect of Renal Impairment on the Pharmacokinetics of NN9535
Plain-language guide to NCT00833716: phase 1 non-randomized trial of Semaglutide, 62 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00833716
- Phase
- phase 1
- Status
- completed
- Start
- 2009-02-02
- Completion (planned or actual)
- 2010-07-26
- Participants
- 62 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 2; Renal Impairment
- 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 the United States of America (USA).
It had 1 arm (groups): A (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 62 actual participants took part.
It was open to people of any sex aged from 18 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject). Subjects meeting the pre-defined GFR (glomerular filtration rate) criteria (estimated by the Cockcroft \& Gault formula) for any of the renal function groups. Body Mass Index (BMI) equal to or less than 40kg/m2.
The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: known or suspected allergy to trial product(s) or related products; renal transplanted patients; certain cardiac problems (heart failure, unstable angina, mi (myocardial infarction) within the last 3 months).
How the Study Was Run
Design: non-randomized, single-group and open-label.
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.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2009-02-02 with completion listed for 2010-07-26.
It ran at 3 sites in United States (3).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): AUC of NN9535 (time frame: at 21 days).
It also tracked 1 secondary outcome, for example Laboratory safety, adverse events.
What This Means in Plain Language
Put simply, this is a phase 1, non-randomized trial of Semaglutide in 62 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.