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Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant

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NCT05670379

Sponsored by Vivani Medical, Inc (industry) · VANI — their whole pipeline →. With Avance Clinical Pty Ltd..

Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
24actual
Sites
1
Country
Australia

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2024-12-20actualWhen the study began enrolling
Primary completion2025-08-21actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2025-08-21actualThe whole study's end, after follow-up
First posted2023-01-04actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2025-09-23actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

  • Overweight and Obesity
  • Type2diabetes

Interventions

  • Combination product: Exenatide Implant — also filed as NPM115/NPM119
  • Drug: Bydureon BCise (exenatide extended release)
  • Drug: Semaglutide, 1.0 mg/mL — also filed as Wegovy, Ozempic

Primary outcomes

what the primary-completion date above is the date OF
Area under the plasma concentration-time curve (AUC)
measured 9 weeks
Maximum plasma concentration observed (Cmax)
measured 9 weeks
Time to maximum plasma concentration observed (Tmax)
measured 9 weeks
Adverse events
measured 9 weeks

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