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Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant
Plain-language guide to NCT05670379: phase 1 randomized trial of Semaglutide and Exenatide, 24 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05670379
- Phase
- phase 1
- Status
- completed
- Start
- 2024-12-20
- Completion (planned or actual)
- 2025-08-21
- Participants
- 24 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Overweight and Obesity; Type2diabetes
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Semaglutide and Exenatide.
The purpose of this study is to evaluate the safety, tolerability and drug levels of an exenatide implant administered subcutaneously.
It had three arms (groups): Exenatide Implant (experimental), Bydureon BCise (exenatide extended release) (active comparator) and Semaglutide (active comparator).
The registry classes the interventions as combination product and drug.
Who Took Part
Enrollment: 24 actual participants took part.
It was open to people of any sex aged from 18 years up to 55 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: BMI 27 to 40 kg/m\^2.
The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: history of type 1 or type 2 diabetes; has medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia (men ii) or a family history of mtc or men ii; current or past exposure to exenatide.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Being open-label, the Semaglutide study did not mask who received what.
It started in 2024-12-20 with completion listed for 2025-08-21.
It ran at 1 site in Australia.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Area under the plasma concentration-time curve (AUC) (time frame: 9 weeks). Maximum plasma concentration observed (Cmax) (time frame: 9 weeks). Time to maximum plasma concentration observed (Tmax) (time frame: 9 weeks).
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Semaglutide and Exenatide 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 and the Exenatide compound page, all human trials.
Our Notes on the Compounds
Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).
Exenatide: A 39-amino-acid GLP-1 receptor agonist first identified in Gila monster venom; sold as Byetta and Bydureon for type 2 diabetes.
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.