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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05670379




Registration number
NCT05670379
Ethics application status
Date submitted
13/12/2022
Date registered
4/01/2023

Titles & IDs
Public title
Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant
Scientific title
A Randomized, Parallel-Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of Exenatide Implant
Secondary ID [1] 0 0
VANI-NP-001
Universal Trial Number (UTN)
Trial acronym
LIBERATE-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and Obesity 0 0
Type2diabetes 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Exenatide Implant
Treatment: Drugs - Bydureon BCise (exenatide extended release)
Treatment: Drugs - Semaglutide, 1.0 mg/mL

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


Other interventions: 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.

Treatment: Drugs: Bydureon BCise (exenatide extended release)
glucagon-like peptide-1 (GLP-1) receptor agonist

Treatment: Drugs: Semaglutide, 1.0 mg/mL
glucagon-like peptide-1 (GLP-1) receptor agonist
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area under the plasma concentration-time curve (AUC)
Timepoint [1] 0 0
9 weeks
Primary outcome [2] 0 0
Maximum plasma concentration observed (Cmax)
Timepoint [2] 0 0
9 weeks
Primary outcome [3] 0 0
Time to maximum plasma concentration observed (Tmax)
Timepoint [3] 0 0
9 weeks
Primary outcome [4] 0 0
Adverse events
Timepoint [4] 0 0
9 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/12/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
CMax - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Vivani Medical, Inc
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Avance Clinical Pty Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lisa Porter, MD
Address 0 0
Vivani Medical, Inc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05670379