A Trial of LY3056480 in Patients With SNLH

Sensorineural Hearing Loss Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05061758
• Other study ID #: AUT-003
• Status: Withdrawn
• Phase: Phase 2
• Start date: September 2022
• Est. completion date: March 2025

Study information

• Verified date: August 2022
• Source: Audion Therapeutics BV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A phase 2 trial with LY3056480 in patients with stable SNHL

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss

Intervention

Drug:
• LY3056480
LY3056480 is an inhibitor of gamma-secretase

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	New York Eye and Ear Infirmary ICAHN school of Medicine Mount Sinai	New York	New York
United States	Eastern Virginia Medical School	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Audion Therapeutics BV

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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