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Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant

NCT05670379 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-09-23

No results posted yet for this study

Summary

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

Conditions

  • Overweight and Obesity
  • Type2diabetes

Interventions

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.

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

Sponsors & Collaborators

  • Avance Clinical Pty Ltd.

    collaborator INDUSTRY

  • Vivani Medical, Inc

    lead INDUSTRY

Principal Investigators

  • Lisa Porter, MD · Vivani Medical, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-20
Primary Completion
2025-08-21
Completion
2025-08-21
FDA Drug
Yes
FDA Device
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05670379 on ClinicalTrials.gov