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LY3056480 for Hearing Loss (VESTA Trial)

Phase 2
Waitlist Available
Research Sponsored by Audion Therapeutics BV
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female between 18 - 65 years of age
Male or female between 18 - 65 years of age;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

VESTA Trial Summary

This trial is testing a new drug to see if it can help people with stable hearing loss.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects of LY3056480 are not specified here but could include reactions typical of new medications such as headaches, nausea, dizziness or allergic responses. Participants will be monitored closely for any adverse effects.

VESTA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.
Select...
I am between 18 and 65 years old.

VESTA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
the efficacy of local treatment with LY3056480 in terms of hearing function

VESTA Trial Design

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
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

Find a Location

Who is running the clinical trial?

Audion Therapeutics BVLead Sponsor

Media Library

LY3056480 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05061758 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the criteria for becoming a participant in this clinical experiment?

"This medical study is searching for 135 individuals with hearing loss between the ages of majority and retirement. To be considered, applicants must meet certain criteria: gender (male or female), six months of consistent hearing deficit (+/- 5dB), a stable word recognition test over half-year period (+/- 6%/3 words)."

Answered by AI

How does LY3056480's safety profile measure up against other treatments?

"The safety of LY3056480 is estimated to be a 2, considering the available data from this Phase 2 trial that suggests it has some level of security but no efficacy evidence."

Answered by AI

Does this clinical trial include individuals beyond the age of 60?

"According to the trial's inclusion criteria, only patients aged 18-65 are eligible for enrollment. There is also a separate set of 54 studies dedicated exclusively to minors and 129 specifically designed for senior citizens."

Answered by AI

Are researchers currently recruiting participants for the experiment?

"Data posted on clinicaltrials.gov reveals that the recruitment period for this trial has come to a close, with it originally being listed on September 1st 2022 and last amended February 15th 2022. Nevertheless, there are still 165 other studies accepting patients at present day."

Answered by AI

Who else is applying?

What state do they live in?
New York
Iowa
Michigan
Other
How old are they?
65+
18 - 65
What site did they apply to?
New York Eye and Ear Infirmary ICAHN school of Medicine Mount Sinai
Eastern Virginia Medical School
Northwestern University Feinberg School of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

My son proggressively losing his hearing. I've been all over the internet and at the moment there's no other solution against hearing loss.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Trial of LY3056480 in Patients With SNLH
2022. "A Trial of LY3056480 in Patients With SNLH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05061758.
All > Sensorineural Hearing Loss > Hearing Loss
~22 spots leftby Sep 2024
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