Overweight and ObesityPhase 1LIBERATE-1NCT05670379
Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant
A Phase 1 study testing Exenatide Implant, Bydureon BCise (exenatide extended release) and Semaglutide, 1.0 mg/mL in people with Overweight and Obesity and Type2diabetes, run by Vivani Medical, Inc at 1 site in Australia.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and drug levels of an exenatide implant administered subcutaneously. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Type2diabetes
- What is being tested?
- Exenatide Implant, Bydureon BCise (exenatide extended release) and Semaglutide, 1.0 mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 20 Dec 2024to 21 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Overweight and Obesity, Type2diabetes
- Being tested
- Exenatide Implant, Bydureon BCise (exenatide extended release), Semaglutide, 1.0 mg/mL
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exenatide ImplantCombination product
Also called NPM115/NPM119
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/mLDrug
Also called Wegovy, Ozempic
glucagon-like peptide-1 (GLP-1) receptor agonist
| Study group | Role | What they receive |
|---|---|---|
| Exenatide Implant | Experimental | 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. Receives: Combination Product: Exenatide Implant |
| Bydureon BCise (exenatide extended release) | Active comparator | 2 mg subcutaneous injection every week for a duration of 9 weeks Receives: Drug: Bydureon BCise (exenatide extended release) |
| Semaglutide | Active comparator | 1.0 mg subcutaneous injection every week for a duration of 9 weeks Receives: Drug: Semaglutide, 1.0 mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve (AUC)
Total exenatide concentration
Measured: 9 weeks
Maximum plasma concentration observed (Cmax)
Maximal exenatide concentration
Measured: 9 weeks
Time to maximum plasma concentration observed (Tmax)
Time to reach maximal exenatide concentration
Measured: 9 weeks
Adverse events
Incidence of treatment-emergent adverse events
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start20 Dec 2024
- Primary completion21 Aug 2025
- Study completion21 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivani Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avance Clinical Pty Ltd.
- Responsible party
- Sponsor
- Investigators
- Lisa Porter, MD, Study director, Vivani Medical, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670379
- Sponsor's protocol ID
- VANI-NP-001
- Acronym
- LIBERATE-1
- Status last verified
- Sep 2025
- First submitted
- 13 Dec 2022
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Exenatide Implant
- ClinicalTrials.gov ID
- NCT05670379
- Acronym / sponsor ID
- LIBERATE-1 / VANI-NP-001
- Conditions
- Overweight and Obesity, Type2diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Vivani Medical, IncIndustry (pharma, biotech, devices)
- Collaborators
- Avance Clinical Pty Ltd.
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 21 Aug 2025 (actual)
- Study completion
- 21 Aug 2025 (actual)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability and drug levels of an exenatide implant administered subcutaneously.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exenatide Implant | Experimental | Combination Product: Exenatide ImplantOne 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) | Active comparator | Drug: Bydureon BCise (exenatide extended release)2 mg subcutaneous injection every week for a duration of 9 weeks |
| Semaglutide | Active comparator | Drug: Semaglutide, 1.0 mg/mL1.0 mg subcutaneous injection every week for a duration of 9 weeks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exenatide ImplantAlso: NPM115/NPM119Exenatide 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. | Combination product | Exenatide Implant |
| Bydureon BCise (exenatide extended release)glucagon-like peptide-1 (GLP-1) receptor agonist | Drug | Bydureon BCise (exenatide extended release) |
| Semaglutide, 1.0 mg/mLAlso: Wegovy, Ozempicglucagon-like peptide-1 (GLP-1) receptor agonist | Drug | Semaglutide |
Primary outcome
Area under the plasma concentration-time curve (AUC)
Time frame: 9 weeks
Total exenatide concentration
Maximum plasma concentration observed (Cmax)
Time frame: 9 weeks
Maximal exenatide concentration
Time to maximum plasma concentration observed (Tmax)
Time frame: 9 weeks
Time to reach maximal exenatide concentration
Adverse events
Time frame: 9 weeks
Incidence of treatment-emergent adverse events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Porter, MD study director
Vivani Medical, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Exenatide Implant, Bydureon BCise (exenatide extended release) and Semaglutide, 1.0 mg/mL in people with Overweight and Obesity and Type2diabetes, run by Vivani Medical, Inc at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration-time curve (AUC) (time frame: 9 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.