COMBINATION_PRODUCT
Exenatide Implant
Exenatide Implant is a drug:device combination that delivers steady levels of exenatide, a glucagon-like peptide-1(GLP-1) receptor agonist, for an extended period of time following subdermal insertion.
Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant
Status
Completed
Phase
Phase 1
Enrollment
24
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
The purpose of this study is to evaluate the safety, tolerability and drug levels of an exenatide implant administered subcutaneously.
Interventions
Treatment arms and agents.
DRUG
Bydureon BCise (exenatide extended release)
glucagon-like peptide-1 (GLP-1) receptor agonist
DRUG
Semaglutide, 1.0 mg/mL
glucagon-like peptide-1 (GLP-1) receptor agonist
Timeline
From registration to results.
First posted
Jan 4, 2023
Study start
Dec 20, 2024
Primary completion
Aug 21, 2025
Study completion
Aug 21, 2025
Results posted
Not reported
Registry updated
Sep 23, 2025
Outcomes
What the study measures.
Primary outcomes
Area under the plasma concentration-time curve (AUC)
Time frame · 9 weeks
Total exenatide concentration
Maximum plasma concentration observed (Cmax)
Time frame · 9 weeks
Maximal exenatide concentration
Time to maximum plasma concentration observed (Tmax)
Time frame · 9 weeks
Time to reach maximal exenatide concentration
Adverse events
Time frame · 9 weeks
Incidence of treatment-emergent adverse events
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Sex
- ALL
- Healthy volunteers
- Yes
Inclusion Criteria: * BMI 27 to 40 kg/m\^2 * Estimated glomerular filtration rate (eGFR) \>/= 90 mL/min/1.73 m\^2 * HbA1c \< 6.0% and FPG \< 6.7 mol/L Exclusion Criteria: * Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being * History of Type 1 or Type 2 Diabetes * History of, or currently has, acute or chronic pancreatitis or has triglyceride concentrations ≥500 mg/dL * 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
Study locations
1 registered sites.
Australia. Showing up to 24 locations stored in the fast local snapshot.
CMax
Adelaide, Australia
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Exenatide.
NCT IDStudyPhase / statusEnrollmentUpdated
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Recruiting
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Phase 3
Completed
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Not applicable
Active, not recruiting
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Phase 3
Completed
44
2026-05
Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's Disease
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Completed
194
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.