A Trial of LY3056480 in Patients With SNLH

NCT05061758 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: AUT-003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

A phase 2 trial with LY3056480 in patients with stable SNHL

Conditions

Sensorineural Hearing Loss

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Four injections of 250µg LY3056480

EXPERIMENTAL

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

Four injections of placebo

PLACEBO COMPARATOR

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

Interventions

LY3056480 DRUG

LY3056480 is an inhibitor of gamma-secretase

Four injections of 250µg LY3056480; Four injections of placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Audion Therapeutics BV: lead

Study Sites (3)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

New York Eye and Ear Infirmary ICAHN school of Medicine Mount Sinai

New York, New York, 10010, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: double blinded, randomized, placebo controlled, multi center efficacy phase 2 study

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 30, 2021
• Study Start: September 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: March 1, 2025
• Last Updated: August 25, 2022

Record last verified: 2022-08

Locations

US (3)