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A Trial of LY3056480 in Patients With SNLH (VESTA)

Primary Purpose

Sensorineural Hearing Loss

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LY3056480
Sponsored by
Audion Therapeutics BV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sensorineural Hearing Loss

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University Feinberg School of Medicine
  • New York Eye and Ear Infirmary ICAHN school of Medicine Mount Sinai
  • Eastern Virginia Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Four injections of 250µg LY3056480

Four injections of placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 15, 2021
Last Updated
August 23, 2022
Sponsor
Audion Therapeutics BV
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1. Study Identification

Unique Protocol Identification Number
NCT05061758
Brief Title
A Trial of LY3056480 in Patients With SNLH
Acronym
VESTA
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Study put on hold
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Audion Therapeutics BV

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensorineural Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
double blinded, randomized, placebo controlled, multi center efficacy phase 2 study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Four injections of 250µg LY3056480
Arm Type
Experimental
Arm Description
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
Arm Title
Four injections of placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
LY3056480
Intervention Description
LY3056480 is an inhibitor of gamma-secretase
Primary Outcome Measure Information:
Title
the efficacy of local treatment with LY3056480 in terms of hearing function
Description
• 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female between 18 - 65 years of age; Minimum of six months of documented stable hearing loss (+/- 5dB); A documented stable word recognition test (stable for ~ 6 months +/- 6%/3 words) Exclusion Criteria: Presenting with a primary complaint of tinnitus 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 History of suspected or diagnosed genetic cause of hearing loss; Partial deafness as defined as hearing loss in any frequency (up to 8 kHz) greater than 80dB 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 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) Any therapy known as ototoxic Participant in a previous trial of LY3056480
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
New York Eye and Ear Infirmary ICAHN school of Medicine Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Eastern Virginia Medical School
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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A Trial of LY3056480 in Patients With SNLH

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