Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant

Phase 1

Not yet recruiting

• Conditions: Overweight and Obesity; Type2diabetes
• Interventions: Drug: Semaglutide, 1.0 mg/mL; Combination Product: Exenatide Implant; Drug: Bydureon BCise (exenatide extended release)

• Registration Number: NCT05670379
• Lead Sponsor: Vivani Medical, Inc

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and drug levels of an exenatide implant administered subcutaneously.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-13
• Study First Submitted QC: 2022-12-20
• Study First Posted: 2023-01-04
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-29
• Study Start: 2024-11
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Semaglutide	Semaglutide, 1.0 mg/mL	1.0 mg subcutaneous injection every week for a duration of 9 weeks
Exenatide Implant	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.
Bydureon BCise (exenatide extended release)	Bydureon BCise (exenatide extended release)	2 mg subcutaneous injection every week for a duration of 9 weeks

Primary Outcome Measures

Name	Time	Method
Adverse events	9 weeks	Incidence of treatment-emergent adverse events
Area under the plasma concentration-time curve (AUC)	9 weeks	Total exenatide concentration
Maximum plasma concentration observed (Cmax)	9 weeks	Maximal exenatide concentration
Time to maximum plasma concentration observed (Tmax)	9 weeks	Time to reach maximal exenatide concentration