A study of the safety and efficacy of a new drug, a gamma secretase inhibitor, to treat people with sensorineural hearing loss.

A phase I/II multiple ascending dose open-label safety and efficacy study of the Notch Inhibitor LY3056480 in patients with mild to moderate sensorineural hearing loss. - REGAIN

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004544-10-GB

Enrollment

Registered

2017-04-28

Start date

2017-09-18

Completion date

Unknown

Last updated

2019-12-16

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

Conditions

Sensorineural hearing loss (SNHL) MedDRA version: 20.0 Level: LLT Classification code 10040016 Term: Sensorineural hearing loss System Organ Class: 100000004854

Interventions

Product Name: Notch Inhibitor LY3056480 Pharmaceutical Form: Solution for injection INN or Proposed INN: LY3056480 CAS Number: 2064292-78-8 Current Sponsor code: LY3056480 Other descriptive name: Notc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female between 18 and 80 years of age; 2. A primary complaint of hearing loss of =20 years in duration, the history suggesting this hearing-loss to be of age-related, noise-induced or idiopathic origin; 3. A bilateral, symmetrical (=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: 1. Presenting with a primary complaint of tinnitus 2. A ‘true’ air-bone gap =15 dBHL in 3 or more contiguous frequencies between 0.5, 1, 2, 4 kHz 3. History of suspected or diagnosed genetic cause of hearing loss 4. Suspected or known diagnosis of 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 5. Evidence of acute or chronic otitis media or otitis externa on examination; or a history of middle ear pathology and/or surgery 6. Any therapy known as ototoxic within 12 months of screening

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objectives of this trial (Part B) are: 1. Main objective is to establish the efficacy of local treatment with LY3056480 in terms of hearing at 12 weeks; 2. To establish the efficacy of local treatment with LY3056480 in terms of hearing at 6 weeks; 3. To assess the safety and tolerance of local treatment with LY3056480 ;Secondary Objective: Not applicable;Primary end point(s): Primary outcome measure for part B is change in hearing from baseline at week 12 in the treated ear accross three frequencies as measured by pure tone audiometry.;Timepoint(s) of evaluation of this end point: Safety endpoints will be evaluated from baseline up to week 12.	—

Measure

Time frame

Main Objective: The main objectives of this trial (Part B) are: 1. Main objective is to establish the efficacy of local treatment with LY3056480 in terms of hearing at 12 weeks; 2. To establish the efficacy of local treatment with LY3056480 in terms of hearing at 6 weeks; 3. To assess the safety and tolerance of local treatment with LY3056480 ;Secondary Objective: Not applicable;Primary end point(s): Primary outcome measure for part B is change in hearing from baseline at week 12 in the treated ear accross three frequencies as measured by pure tone audiometry.;Timepoint(s) of evaluation of this end point: Safety endpoints will be evaluated from baseline up to week 12.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints for Part B are change from baseline to 6 and 12 weeks in hearing, tinnitus, balance, facial nerve function and taste, and occurrence and severity of local and systemic adverse events related to treatment and/or procedure, and clinically significant changes in ECG, vital signs, physical examination findings and laboratory tests.;Timepoint(s) of evaluation of this end point: At 6 and 12 weeks after starting the treatment.	—

Measure

Time frame

Secondary end point(s): Secondary endpoints for Part B are change from baseline to 6 and 12 weeks in hearing, tinnitus, balance, facial nerve function and taste, and occurrence and severity of local and systemic adverse events related to treatment and/or procedure, and clinically significant changes in ECG, vital signs, physical examination findings and laboratory tests.;Timepoint(s) of evaluation of this end point: At 6 and 12 weeks after starting the treatment.

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Countries

Germany, Greece, United Kingdom

Contacts

Public ContactClinical Trial Information

Audion Therapeutics

rjrutten@audiontherapeutics.com0031 6 46767255

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026