Phase 2 Hearing Loss Trial, Recruiting NCT05821959 Sponsor: Akouos, Inc. Condition: Hearing Loss
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Phase 2 Hearing Loss Trial, Recruiting

NCT05821959
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People of any age may be considered, depending on which group (cohort) within the trial they are being assessed for
  • People who have at least two changes (mutations) in a specific gene called the otoferlin gene
  • People who have been assessed and found to have severe hearing loss in both ears, caused by a problem with the inner ear or hearing nerve (confirmed through a specialised hearing test called an ABR)
  • People whose inner ear still shows some preserved function on a specific type of hearing test called a DPOAE test
  • People who are able and willing to follow all study requirements, including taking part in a separate long-term follow-up study after this trial ends

Who may not be able to join:

  • People who have ongoing ear infections, unusual ear anatomy, or other health conditions that would make surgery, anaesthesia, or receiving an experimental gene therapy unsafe
  • People who already have a cochlear implant in the ear that would be treated in this trial
  • People who have taken part in a study involving an experimental drug within the six months before treatment, or who have ever previously taken part in any gene therapy clinical trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Peter Marks, MD, Eli Lilly and Company

Phone: +1 857-410-1816

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Akouos, Inc.
Registry
ClinicalTrials.gov
Start date
15 September 2023
Est. completion
1 October 2028

Where this trial is recruiting

🇨🇦 Canada 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Frequency of Adverse Events (AEs)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov