A Trial of LY3056480 in Patients With SNLH (VESTA)

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

A phase 2 trial with LY3056480 in patients with stable SNHL

Study Overview

• Status: Withdrawn
• Conditions: Sensorineural Hearing Loss
• Intervention / Treatment: Drug: LY3056480

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 Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine
  • New York
    • New York, New York, United States, 10010
      • New York Eye and Ear Infirmary ICAHN school of Medicine Mount Sinai
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Eastern Virginia Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: LY3056480; LY3056480 is an inhibitor of gamma-secretase
Placebo Comparator: 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	Drug: LY3056480; LY3056480 is an inhibitor of gamma-secretase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Audion Therapeutics BV

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: September 27, 2021
• First Posted (Actual): September 30, 2021

Study Record Updates

• Last Update Posted (Actual): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural
• Other Study ID Numbers: AUT-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No