Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant

Sponsor
Vivani Medical, Inc
Study ID
NCT05670379
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Exenatide Implant — COMBINATION_PRODUCT
    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) — DRUG
    glucagon-like peptide-1 (GLP-1) receptor agonist
  • Semaglutide, 1.0 mg/mL — DRUG
    glucagon-like peptide-1 (GLP-1) receptor agonist

Study Details

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

Key Dates

Start date
Dec 20, 2024
Status verified
Sep 2025
Primary completion
Aug 21, 2025
Completion
Aug 21, 2025

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: Bydureon BCise (exenatide extended release)
    2 mg subcutaneous injection every week for a duration of 9 weeks
  • Active Comparator: Semaglutide
    1.0 mg subcutaneous injection every week for a duration of 9 weeks

Primary Outcome Measure

Area under the plasma concentration-time curve (AUC) [ Time Frame: 9 weeks ]

Related Studies