Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant (LIBERATE-1)

September 17, 2025 updated by: Vivani Medical, Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • NPM115/NPM119
Active Comparator: Bydureon BCise (exenatide extended release)
2 mg subcutaneous injection every week for a duration of 9 weeks
Drug: Bydureon BCise (exenatide extended release)
glucagon-like peptide-1 (GLP-1) receptor agonist
Active Comparator: Semaglutide
1.0 mg subcutaneous injection every week for a duration of 9 weeks
Drug: Semaglutide, 1.0 mg/mL
glucagon-like peptide-1 (GLP-1) receptor agonist
Other Names:
  • Wegovy, Ozempic

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c (HbA1c)
Time Frame: 12 weeks
Measure of average glycemic control
12 weeks
Fasting plasma glucose (FPG)
Time Frame: 12 weeks
Measure of short-term glycemic control
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vivani Medical, Inc

Collaborators

Avance Clinical Pty Ltd.

Investigators

  • Study Director: Lisa Porter, MD, Vivani Medical, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2024

Primary Completion (Actual)

August 21, 2025

Study Completion (Actual)

August 21, 2025

Study Registration Dates

First Submitted

December 13, 2022

First Submitted That Met QC Criteria

December 20, 2022

First Posted (Actual)

January 4, 2023

Study Record Updates

Last Update Posted (Estimated)

September 23, 2025

Last Update Submitted That Met QC Criteria

September 17, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VANI-NP-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Overweight and Obesity

Clinical Trials on Bydureon BCise (exenatide extended release)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe