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Gene Therapy Trial for Otoferlin Gene-mediated Hearing Loss

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: AAVAnc80-hOTOF via Akouos Delivery Device (combination product), AAVAnc80-hOTOF via Akouos Delivery Device and Precision Delivery Mechanism (combination product)
How long the study runs: Study runs about 75 months (dates as stated)
About the drug or intervention: AAVAnc80-hOTOF via Akouos Delivery Device — combination product: AAVAnc80-hOTOF is a sterile suspension intended to be administered via a one-time unilateral intracochlear administration using the Akouos Delivery Device. · AAVAnc80-hOTOF via Akouos Delivery Device and Precision Delivery Mechanism — combination product: AAVAnc80-hOTOF is a sterile suspension intended to be administered via a one-time bilateral intracochlear administration using the Akouos Delivery Device together with the Precision Delivery Mechanism.
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: Not specified
Who: All
Number of participants: 48
Started: 2023-09-15
Last checked: 2026-09

Plain English Summary

What is this study?

• Testing a new treatment for sensorineural hearing loss, bilateral
• Phase3 - 48 participants
• Part A of this trial evaluated 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 (LY888891) and evaluated the Akouos Delivery Device, together with the Precision Delivery Mechanism (as applicable), to safely achieve the intended product performance

Who can take part?

• Adults
• Diagnosed with sensorineural hearing loss, bilateral

Where?

• London - University College London

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

Part A of this trial evaluated 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 (LY888891) and evaluated the Akouos Delivery Device, together with the Precision Delivery Mechanism (as applicable), to safely achieve the intended product performance. Part B of the trial is an open-label, global expansion phase to confirm the efficacy and safety of one dose level of AAVAnc80-hOTOF administered in one or both ear(s). Part B will also evaluate the Intracochlear Delivery System (IDS), which consists of the Akouos Delivery Device, the Precision Delivery Mechanism, and an off-the-shelf syringe. Part C is a region-specific expansion phase. Part C participants will receive the same dose level of AAVAnc80-hOTOF as participants in Part B, in one or both ear(s) utilizing the IDS. Part D is a sequential administration phase that allows participants who received AAVAnc80-hOTOF previously in a single ear to receive AAVAnc80-hOTOF administration in the other ear utilizing the IDS.

More detail

The following two dose levels were tested in Part A: * Up to 4.1E11 total vg/cochlea * Up to 8.1E11 total vg/cochlea The following dose level will be tested in Part B, C, and D: • 8.1E11 total vg/cochlea

Sensorineural Hearing Loss, Bilateral

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: Not specified
Who can join: All genders

What the study is looking for

✓Criteria for Inclusion:
✓Participants may be of any age, based on Cohort Criteria
✓At least two mutations in the otoferlin gene
✓Clinical presentation of Profound (Part A) or Severe to Profound (Parts B, C, and D) bilateral sensorineural hearing...
✓Preserved distortion product otoacoustic emissions (DPOAEs)

See the full criteria

Criteria for Inclusion: 1. Participants may be of any age, based on Cohort Criteria 2. At least two mutations in the otoferlin gene 3. Clinical presentation of Profound (Part A) or Severe to Profound (Parts B, C, and D) bilateral sensorineural hearing loss as assessed by ABR 4. Preserved distortion product otoacoustic emissions (DPOAEs) 5. Able and willing to comply with all study requirements, including willingness to participate in a separate long term follow-up study after completion of this trial Criteria for Exclusion: 1. Persistent ear infections, anatomic or other abnormalities of the ear, and/or medical conditions that would contraindicate undergoing surgery, anesthesia, and/or administration of investigational gene therapy 2. Cochlear Implant(s) in the ear(s) to receive AAVAnc80-hOTOF 3. Prior participation in a clinical trial with an investigational drug, within six months prior to administration, or any prior participation in a gene therapy clinical trial (with the exception of AK-OTOF-101 for Part D participants)

Where Is This Study? (1 UK site)

University College London

London NW1 2PG, United Kingdom

ACTIVE_NOT_RECRUITING

Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net 020 3447 9825

How to Get in Touch

Lilly Clinical Trials

Sponsor contact

CONTACT

+1 857-410-1816 AkouosClinicalTrials@Lilly.com

Data sourced from ClinicalTrials.gov · Last verified: 2026-09