Skip to main content
OpenTrials
Completed

NCT Number: NCT05670379

Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type2diabetes

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CMax

Adelaide, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: NPM115/NPM119

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

Other names: Wegovy, Ozempic

Primary outcomes

  1. Area under the plasma concentration-time curve (AUC)

    Time frame: 9 weeks

    Total exenatide concentration

  2. Maximum plasma concentration observed (Cmax)

    Time frame: 9 weeks

    Maximal exenatide concentration

  3. Time to maximum plasma concentration observed (Tmax)

    Time frame: 9 weeks

    Time to reach maximal exenatide concentration

  4. Adverse events

    Time frame: 9 weeks

    Incidence of treatment-emergent adverse events

Sponsors and collaborators

Lead sponsor

Vivani Medical, Inc

Industry

Collaborators

  • Avance Clinical Pty Ltd.

Registry information

Official study title

A Randomized, Parallel-Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Exenatide Implant

Acronym: LIBERATE-1

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 4, 2023
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.