Clinical Trial

Gene Therapy Trial for Otoferlin Gene-mediated Hearing Loss

Recruiting Phase 1/2
View on ClinicalTrials.gov →
Summary
Part A of this trial will evaluate the safety and tolerability of a single surgical administration procedure in one or both ear(s) with one of two dose levels of AAVAnc80-hOTOF and will evaluate the Akouos Delivery Device, together with the Precision Delivery Mechanism, to safely achieve the intended product performance.
Protocol Amendment History 17 amendments
This ClinicalTrials.gov record has been amended 17 times since 2023-04-18; most recent amendment 2026-03-03.
Trial Details
NCT Number NCT05821959
Lead Sponsor Akouos, Inc.
Collaborators: Eli Lilly and Company
Conditions Sensorineural Hearing Loss, Bilateral
Enrollment 22 participants
Start Date 2023-09-15
Primary Completion 2028-10 (estimated)
Study Completion 2028-10 (estimated)
Updated on ClinicalTrials.gov 2026-03-04