A Trial of LY3056480 in Patients With SNLH

Phase 2

Withdrawn

• Conditions: Sensorineural Hearing Loss
• Interventions: Drug: LY3056480

• Registration Number: NCT05061758
• Lead Sponsor: Audion Therapeutics BV

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 Timeline

• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-09-27
• Study First Posted: 2021-09-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-23
• Last Update Posted: 2022-08-25
• Study Start: 2022-09
• Primary Completion: 2024-09
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Four injections of 250µg LY3056480	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
Four injections of placebo	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

Primary Outcome Measures

Name	Time	Method
the efficacy of local treatment with LY3056480 in terms of hearing function	6 months	• Number of drug responders with at least a 2dB improvement in an adaptive sentence in noise test (international matrix test) compared to placebo

Trial Locations

Locations (3)

Eastern Virginia Medical School; 🇺🇸 Norfolk, Virginia, 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