Sensorineural Hearing LossPhase 2VESTANCT05061758
A Trial of LY3056480 in Patients With SNLH
A Phase 2 study testing LY3056480 in people with Sensorineural Hearing Loss, run by Audion Therapeutics BV at 3 sites in United States.
Trial summary
A phase 2 trial with LY3056480 in patients with stable SNHL Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sensorineural Hearing Loss
- What is being tested?
- LY3056480
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2022to Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female between 18 - 65 years of age;
- Minimum of six months of documented stable hearing loss (+/- 5dB);
- A documented stable word recognition test (stable for ~ 6 months +/- 6%/3 words)
Who cannot join
- Presenting with a primary complaint of tinnitus
- 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;
- Partial deafness as defined as hearing loss in any frequency (up to 8 kHz) greater than 80dB
- 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
- 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)
- Any therapy known as ototoxic
- Participant in a previous trial of LY3056480
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
New York Eye and Ear Infirmary ICAHN school of Medicine Mount Sinai
New York, New York, 10010
Eastern Virginia Medical School
Norfolk, Virginia, 23507
About this study
Official title: 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
Read the 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).
- Conditions
- Sensorineural Hearing Loss
- Being tested
- LY3056480
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3056480Drug
LY3056480 is an inhibitor of gamma-secretase
| Study group | Role | What they receive |
|---|---|---|
| Four injections of 250µg LY3056480 | Experimental | 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 Receives: Drug: LY3056480 |
| Four injections of placebo | Placebo comparator | 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 Receives: Drug: LY3056480 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study startSep 2022 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionMar 2025 (estimated)
Why it stopped: Study put on hold
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensorineural Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blinded, randomized, placebo controlled, multi center efficacy phase 2 study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Audion Therapeutics BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061758
- Sponsor's protocol ID
- AUT-003
- Acronym
- VESTA
- Status last verified
- Aug 2022
- First submitted
- 15 Sep 2021
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05061758
- Acronym / sponsor ID
- VESTA / AUT-003
- Conditions
- Sensorineural Hearing Loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study put on hold
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Audion Therapeutics BVIndustry (pharma, biotech, devices)
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 30 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 2 trial with LY3056480 in patients with stable SNHL
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double blinded, randomized, placebo controlled, multi center efficacy phase 2 study
| Arm | Type | Receives |
|---|---|---|
| Four injections of 250µg LY3056480 | Experimental | Drug: LY3056480The 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 |
| Four injections of placebo | Placebo comparator | Drug: LY3056480The 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 may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female between 18 - 65 years of age;
- Minimum of six months of documented stable hearing loss (+/- 5dB);
- A documented stable word recognition test (stable for ~ 6 months +/- 6%/3 words)
Key exclusion criteria (8 listed)
- Presenting with a primary complaint of tinnitus
- 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;
- Partial deafness as defined as hearing loss in any frequency (up to 8 kHz) greater than 80dB
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY3056480LY3056480 is an inhibitor of gamma-secretase | Drug | Four injections of 250µg LY3056480, Four injections of placebo |
Primary outcome
the efficacy of local treatment with LY3056480 in terms of hearing function
Time frame: 6 months
• Number of drug responders with at least a 2dB improvement in an adaptive sentence in noise test (international matrix test) compared to placebo
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY3056480 in people with Sensorineural Hearing Loss, run by Audion Therapeutics BV at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the efficacy of local treatment with LY3056480 in terms of hearing function (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.