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A Trial of LY3056480 in Patients With SNLH (VESTA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05061758
Recruitment Status : Withdrawn (Study put on hold)
First Posted : September 30, 2021
Last Update Posted : August 25, 2022
Sponsor:
Information provided by (Responsible Party):
Audion Therapeutics BV

Brief Summary:
A phase 2 trial with LY3056480 in patients with stable SNHL

Condition or disease Intervention/treatment Phase
Sensorineural Hearing Loss Drug: LY3056480 Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double blinded, randomized, placebo controlled, multi center efficacy phase 2 study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Double Blind, Randomized, Placebo Controlled Trial inVEstigating the Effect and Safety of Several Dosing Regimens of LY3056480 in Patients With STAble Sensorineural Hearing Loss
Estimated Study Start Date : September 2022
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
LY3056480 is an inhibitor of gamma-secretase

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
LY3056480 is an inhibitor of gamma-secretase




Primary Outcome Measures :
  1. the efficacy of local treatment with LY3056480 in terms of hearing function [ Time Frame: 6 months ]
    • Number of drug responders with at least a 2dB improvement in an adaptive sentence in noise test (international matrix test) compared to placebo



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05061758


Locations
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United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
United States, New York
New York Eye and Ear Infirmary ICAHN school of Medicine Mount Sinai
New York, New York, United States, 10010
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Audion Therapeutics BV
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Responsible Party: Audion Therapeutics BV
ClinicalTrials.gov Identifier: NCT05061758    
Other Study ID Numbers: AUT-003
First Posted: September 30, 2021    Key Record Dates
Last Update Posted: August 25, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases