LY3056480 for Hearing Loss (VESTA Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Audion Therapeutics BV

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called LY3056480 to see if it can help adults with certain types of hearing loss. The drug is injected directly into the ear. Researchers want to find out if this method can improve hearing in people who haven't had success with other treatments.

Eligibility Criteria

Adults aged 18-65 with stable sensorineural hearing loss (SNHL) can join this trial. They must have consistent word recognition and hearing levels for at least six months. Those with tinnitus, conductive hearing loss, genetic hearing issues, severe deafness in any frequency, or previous LY3056480 trials cannot participate.

Inclusion Criteria

I am between 18 and 65 years old.

Exclusion Criteria

I have hearing loss of more than 15 dB at one frequency or more than 10 dB across two frequencies in one ear.

I have a genetic reason for my hearing loss.

I have had ear infections or surgery on my ears, except for ear tubes as a child.

I have not taken any medication known to affect hearing.

I am experiencing constant ringing in my ears.

I have significant hearing loss in one or more frequencies.

I have a diagnosed or suspected inner ear condition.

Treatment Details

The trial is testing a new medication called LY3056480 to see if it helps people with stable SNHL. It's a phase 2 study which means they're looking at how effective the drug is and gathering more information on its safety.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Four injections of 250µg LY3056480Experimental Treatment1 Intervention

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 II: Four injections of placeboPlacebo Group1 Intervention