Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant
NCT ID: NCT05670379
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2024-12-20
2025-08-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Exenatide Implant
One Exenatide Implant that delivers approximately 52 microgram/day of exenatide will be inserted subdermally just under the skin of the upper outer arm for the 9-week treatment period.
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.
Bydureon BCise (exenatide extended release)
2 mg subcutaneous injection every week for a duration of 9 weeks
Bydureon BCise (exenatide extended release)
glucagon-like peptide-1 (GLP-1) receptor agonist
Semaglutide
1.0 mg subcutaneous injection every week for a duration of 9 weeks
Semaglutide, 1.0 mg/mL
glucagon-like peptide-1 (GLP-1) receptor agonist
Interventions
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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.
Bydureon BCise (exenatide extended release)
glucagon-like peptide-1 (GLP-1) receptor agonist
Semaglutide, 1.0 mg/mL
glucagon-like peptide-1 (GLP-1) receptor agonist
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Estimated glomerular filtration rate (eGFR) \>/= 90 mL/min/1.73 m\^2
* HbA1c \< 6.0% and FPG \< 6.7 mol/L
Exclusion Criteria
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Avance Clinical Pty Ltd.
INDUSTRY
Vivani Medical, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Lisa Porter, MD
Role: STUDY_DIRECTOR
Vivani Medical, Inc
Locations
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CMax
Adelaide, , Australia
Countries
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Other Identifiers
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VANI-NP-001
Identifier Type: -
Identifier Source: org_study_id
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