A Trial of LY3056480 in Patients With SNLH

Launched by AUDION THERAPEUTICS BV · Sep 27, 2021

Keywords

ClinConnect Summary

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).

Gender

ALL

Eligibility criteria

• 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