Study put on hold

A phase 2 trial with LY3056480 in patients with stable SNHL

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).

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