What side effects are associated with this type of intervention?

Common treatments for Sensorineural Hearing Loss (SNHL) include corticosteroids, which can cause side effects such as weight gain, high blood pressure, and mood swings. Ototoxic drugs like aminoglycoside antibiotics and platinum-based chemotherapies can lead to permanent hearing loss and balance issues. Emerging therapies, including those similar to LY3056480, which target specific molecular pathways, may have side effects such as dizziness, nausea, and potential ototoxicity. It is crucial to discuss these potential side effects with a healthcare provider to weigh the benefits and risks of each treatment option.

What prior FDA approvals exist?

Currently, there are no FDA-approved therapeutics specifically for the treatment of Sensorineural Hearing Loss (SNHL). The development of pharmacological treatments for SNHL faces significant challenges, including the limited regeneration capacity of cochlear cells. LY3056480 is being studied in clinical trials for its potential to address this unmet need, but no similar drugs have received FDA approval to date.

What other types of research exist?

Promising alternatives to LY3056480 for SNHL include Bevacizumab and Everolimus. Bevacizumab, an anti-VEGF antibody, has shown efficacy in reducing vestibular schwannoma growth and improving hearing in NF2 patients by inhibiting angiogenesis. Everolimus, an mTORC1 inhibitor, targets cellular pathways involved in cell growth and proliferation, showing potential in treating NF2-related tumors. Both drugs offer novel mechanisms targeting pathways relevant to hearing loss.

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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;

Must not have

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

History of suspected or diagnosed genetic cause of hearing loss

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have a genetic reason for my hearing loss.

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

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I have not taken any medication known to affect hearing.

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I am experiencing constant ringing in my ears.

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I have significant hearing loss in one or more frequencies.

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I have a diagnosed or suspected inner ear condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

the efficacy of local treatment with LY3056480 in terms of hearing function

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

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Sensorineural Hearing Loss (SNHL) often target the molecular pathways involved in cochlear cell damage and auditory nerve function. These treatments include antioxidants to reduce oxidative stress, anti-inflammatory agents to mitigate inflammation, and neurotrophic factors to support nerve cell survival and regeneration. LY3056480, being studied in clinical trials, likely targets specific pathways or receptors involved in hearing loss, such as those regulating cellular stress responses or promoting hair cell regeneration. Understanding these mechanisms is crucial for SNHL patients as it provides insight into how these treatments can potentially restore hearing function or prevent further deterioration by addressing the underlying causes of hearing loss at a molecular level.

Investigational Medicinal Products for the Inner Ear: Review of Clinical Trial Characteristics in ClinicalTrials.gov.An update on drug design strategies to prevent acquired sensorineural hearing loss.Emerging Therapies for Sensorineural Hearing Loss.