Brief Title
A Trial of LY3056480 in Patients With SNLH
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
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).
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
the efficacy of local treatment with LY3056480 in terms of hearing function
Condition
Sensorineural Hearing Loss
Intervention
LY3056480
Study Arms / Comparison Groups
Four injections of 250µg LY3056480
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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
135
Start Date
September 2022
Completion Date
March 2025
Primary Completion Date
September 2024
Eligibility 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
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
, +31613328444, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT05061758
Organization ID
AUT-003
Responsible Party
Sponsor
Study Sponsor
Audion Therapeutics BV
Study Sponsor
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Verification Date
February 2022