CClinicalTrials.gg
Sign In
WithdrawnNCT05061758VESTAUpdated Aug 25, 2022

A Trial of LY3056480 in Patients With SNLH

A Phase 2 interventional study of LY3056480 in Sensorineural Hearing Loss, sponsored by Audion Therapeutics BV. Withdrawn at 3 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-08-25.

Sponsored by Audion Therapeutics BV · Phase 2, Interventional, and Treatment

Why this study was withdrawn
Study put on hold
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

A phase 2 trial with LY3056480 in patients with stable SNHL

Read the detailed description

VESTA is a double blinded, randomized, placebo controlled, multi center efficacy phase 2 study comparing three dosing regimens of 250 µg LY3056480. Adult volunteers with stable mild to moderately-severe SNHL will be recruited through Adult Otolaryngology - Head \& Neck Surgery Services in the US. Four injections of 250µg LY3056480 or placebo administered trans-tympanically into one ear (worse hearing ear).

02

Conditions studied

  • Sensorineural Hearing Loss
03

In context

Hearing Loss

1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.

Browse Hearing Loss studies →

Lead sponsor

This is the only study on the registry with Audion Therapeutics BV as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female between 18 - 65 years of age;
  2. Minimum of six months of documented stable hearing loss (+/- 5dB);
  3. A documented stable word recognition test (stable for \~ 6 months +/- 6%/3 words)

Exclusion criteria

Exclusion Criteria:

  1. Presenting with a primary complaint of tinnitus
  2. Any conductive hearing loss of greater than 15 dB at a single frequency or greater than 10 dB at two or more contiguous octave frequencies in the study ear
  3. History of suspected or diagnosed genetic cause of hearing loss;
  4. Partial deafness as defined as hearing loss in any frequency (up to 8 kHz) greater than 80dB
  5. Suspected or known diagnosis of the following inner ear pathology, congenital hearing loss, fluctuating hearing loss, Ménière's disease, or secondary endolymphatic hydrops, perilymph fistula, cochlear barotrauma, autoimmune hearing loss, radiation-induced hearing loss, retro-cochlear lesion, ototoxicity
  6. Evidence of acute or chronic otitis media or otitis externa on examination; or a history of middle ear pathology and/or surgery (except for ear tubes as a child)
  7. Any therapy known as ototoxic
  8. Participant in a previous trial of LY3056480
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Four injections of 250µg LY3056480

    The treatment will be given transtympanically over the course of 2-7 weeks, according to dosing regimens below. * Group 1 - Regimen 1. Day 1, Day 4, Day 8, Day 11 * Group 2 - Regimen 2. Weekly * Group 3 - Regimen 3. Every two weeks

    Drug: LY3056480

  • Placebo comparator
    Four injections of placebo

    The treatment will be given transtympanically over the course of 2-7 weeks, according to dosing regimens below. * Group 1 - Regimen 1. Day 1, Day 4, Day 8, Day 11 * Group 2 - Regimen 2. Weekly * Group 3 - Regimen 3. Every two weeks

    Drug: LY3056480

Interventions

  • DrugLY3056480

    LY3056480 is an inhibitor of gamma-secretase

06

What researchers measure

Primary outcomes

  1. the efficacy of local treatment with LY3056480 in terms of hearing function

    • Number of drug responders with at least a 2dB improvement in an adaptive sentence in noise test (international matrix test) compared to placebo

    Time frame: 6 months

07

Study locations

3 sites
  • Northwestern University Feinberg School of Medicine
    Chicago, Illinois 60611, United States
  • New York Eye and Ear Infirmary ICAHN school of Medicine Mount Sinai
    New York, New York 10010, United States
  • Eastern Virginia Medical School
    Norfolk, Virginia 23507, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05061758
Lead sponsor
Audion Therapeutics BV
Responsible party
Sponsor
First posted
Sep 30, 2021
Start date
Sep 2022 (estimated)
Primary completion
Sep 2024 (estimated)
Completion
Mar 2025 (estimated)
Last update
Aug 25, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hearing Loss→

Start the discussion