NCT05061758

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• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Audion Therapeutics BV · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Sensorineural Hearing Loss

Interventions

Type	Name	Description
DRUG	LY3056480	LY3056480 is an inhibitor of gamma-secretase

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-09-01
• Completion: 2025-03-01
• First posted: 2021-09-30
• Last updated: 2022-08-25

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study