LIBERATE-1

CompletedPhase 1

Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant

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

Lead sponsor

Vivani Medical, Inc

Assets

Exenatide / GLP-1 / incretin class catch-all / Semaglutide

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers, Obesity / overweight

Eligibility highlights

•BMI 27-40•HbA1c ≤6%

Primary endpoints

•AUC•Cmax observed (Cmax)•Cmax observed (Tmax)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05670379

Org study IDVANI-NP-001

Timeline

Milestones

Study first posted2023-01-04actual

Study start2024-12-20actual

Primary completion2025-08-21actual

Study completion2025-08-21actual

Last update posted2025-09-23actual

Assets

Investigational agents

Exenatide GLP-1 / incretin class catch-all Semaglutide

Who this study enrolls

Healthy volunteersObesity / overweight

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

Area under the plasma concentration-time curve (AUC)

Time frame:9 weeks

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

Maximum plasma concentration observed (Cmax)

Time frame:9 weeks

Cmax

concentration, descriptive

Primary/protocol endpoint

Time to maximum plasma concentration observed (Tmax)

Time frame:9 weeks

Tmax

concentration, descriptive

Primary/protocol endpoint

Adverse events

Time frame:9 weeks

Treatment-emergent AEs (any)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.