A Trial of LY3056480 in Patients With SNLH

NCT ID: NCT05061758

Last Updated: 2022-08-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2025-03-31

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).

Conditions

Sensorineural Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Four injections of 250µg LY3056480

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

Group Type: EXPERIMENTAL

LY3056480

Intervention Type: DRUG

LY3056480 is an inhibitor of gamma-secretase

Four injections of placebo

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

Group Type: PLACEBO_COMPARATOR

LY3056480

Intervention Type: DRUG

LY3056480 is an inhibitor of gamma-secretase

Interventions

LY3056480

LY3056480 is an inhibitor of gamma-secretase

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Audion Therapeutics BV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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, United States

Countries

United States

Other Identifiers

AUT-003

Identifier Type: -

Identifier Source: org_study_id