A Trial of LY3056480 in Patients With SNLH

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05061758

Acronym

VESTA

Enrollment

Registered

2021-09-30

Start date

2022-09-30

Completion date

2025-03-31

Last updated

2022-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sensorineural Hearing Loss

Brief summary

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).

Interventions

DRUGLY3056480

LY3056480 is an inhibitor of gamma-secretase

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

double blinded, randomized, placebo controlled, multi center efficacy phase 2 study

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Male or female between 18 - 65 years of age; 2. Minimum of six months of documented stable hearing loss (+/- 5dB); 3. A documented stable word recognition test (stable for \ 6 months +/- 6%/3 words)

Exclusion criteria

1. Presenting with a primary complaint of tinnitus 2. 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 3. History of suspected or diagnosed genetic cause of hearing loss; 4. Partial deafness as defined as hearing loss in any frequency (up to 8 kHz) greater than 80dB 5. 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 6. 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) 7. Any therapy known as ototoxic 8. Participant in a previous trial of LY3056480

Design outcomes

Primary

Measure	Time frame	Description
the efficacy of local treatment with LY3056480 in terms of hearing function	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026