LY3056480 for Hearing Loss

(VESTA Trial)

Recruiting at 2 trial locations

Overseen By Stephanie Moody, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Audion Therapeutics BV

Must not be taking: Ototoxic drugs

Disqualifiers: Tinnitus, Conductive hearing loss, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 2-7 weeks

135 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on any therapy known to be ototoxic (harmful to the ear), you may not be eligible to participate.

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

Your ability to recognize and understand words has remained consistent over the past six months, with a small allowance for change.

You have had consistent hearing loss for at least six months.

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.

You have taken part in a previous study involving LY3056480.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive four injections of 250µg LY3056480 or placebo transtympanically over 2-7 weeks

2-7 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• LY3056480

Trial Overview 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.

Participant Groups

Group I: Four injections of 250µg LY3056480 Experimental Treatment 1 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 placebo Placebo Group 1 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

Who Is Running the Clinical Trial?

Audion Therapeutics BV

Lead Sponsor

Trials

1

Recruited

140+