Gene Therapy Trial for Otoferlin Gene-mediated Hearing Loss

StatusRecruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary endpoints added 1 → 3 primary endpoints
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Record History

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  1. Primary endpoint(s) modified Show 10 more changesShow less
    • Phase changed: Phase 1/2 → Phase 3
    • Sponsor changed: Akouos, Inc. to Eli Lilly and Company
    • Enrollment increased: 22 → 48 participants
    • Study completion pushed from Oct 2028 to Dec 2029
    • Trial arms changed: 3 → 6
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: 2 to 3
    • Study description expanded, about 21 words
    • Site details revised at 7 of 9 sites
    • Collaborators shortened, about 4 words
  2. Re-verified, no change to tracked fieldsv18
  3. Site contacts updated at 1 of 9 sitesv17
  4. Study sites: 8 to 9v16
  5. Enrollment target: 18 to 22
    • Interventions: AAVAnc80-hOTOF via Akouos Delivery Device (Combination Product), AAVAnc80-hOTOF via Akouos Delivery Device (Combination Product) to AAVAnc80-hOTOF via Akouos Delivery Device (Combination Product), AAVAnc80-hOTOF via Akouos Delivery Device and Precision Delivery Mechanism…
    • Secondary endpoints revised (2)
    • Site contacts updated at 2 of 8 sites
    v15
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  1. Re-verified, no change to tracked fieldsv14
  2. Enrollment target: 14 to 18v13 Show 5 more changesShow less
    • Interventions: AAVAnc80-hOTOF via Akouos Delivery Device (Combination Product) to AAVAnc80-hOTOF via Akouos Delivery Device (Combination Product), AAVAnc80-hOTOF via Akouos Delivery Device (Combination Product)
    • Site contacts updated at 2 of 8 sites
    • Study arms: 2 to 3
    • Eligibility criteria expanded, about 5 words
    • Study description expanded, about 3 words
  3. Study sites: 6 to 8v12
  4. Site contacts updated at 1 of 6 sitesv11
  5. Study sites: 5 to 6v10
  6. Study sites: 4 to 5v9
  7. 2 versions Re-verified since May 30, 2024, no change to tracked fieldsv7-v8
  8. Study sites: 3 to 4
    • Secondary endpoints: details revised at 2 of 2 entries
    • Eligibility criteria expanded, about 1 word
    v6
  9. Eligibility criteria shortened, about 15 wordsv5
  10. Start date changed from estimate of May 2023 to Sep 15, 2023
    • Study sites: 1 to 3
    • Primary and study completion dates: May 2028 to Oct 2028
    v4
  11. Site contact updatedv3
  12. Primary and study completion dates: Apr 2028 to May 2028
    • Start date: Apr 2023 to May 2023
    • Study description expanded, about 15 words
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Eli Lilly
363 trials monitored
See 16 trials at risk
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.
Trial Details
NCT Number NCT05821959
Lead Sponsor Eli Lilly and Company
Conditions
(from sponsor)		 Sensorineural Hearing Loss, Bilateral
Related terms Auditory neuropathy, Deafness, Deafness, Autosomal Recessive 9, Hearing Loss, Hearing Loss, Bilateral, Hearing Loss, Sensorineural
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov