A Trial of LY3056480 in Patients With SNLH

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

Detailed Description
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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).

Official Title
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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

Conditions
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Sensorineural Hearing Loss

Intervention / Treatment
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* Drug: LY3056480


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: double blinded, randomized, placebo controlled, multi center efficacy phase 2 study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Four injections of 250µg LY3056480<br>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<br>* LY3056480 is an inhibitor of gamma-secretase<br>|
| Placebo Comparator: Four injections of placebo<br>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<br>* LY3056480 is an inhibitor of gamma-secretase<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months |