A Trial of LY3056480 in Patients With SNLH

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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

, , 


Verification Date

February 2022