NCT07472907

A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations

A Randomized, Double-blind, Placebo-controlled, Ascending Volume Phase 1B/2A Clinical Trial to Investigate the Safety and Efficacy of a Single Transtympanic Injection of CIL001 (Paliroden) for the Treatment of Cochlear Synaptopathy in Participants With type2 Diabetes

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Cilcare SAS · Industry
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Like retinopathy, neuropathy and nephropathy, sensorineural hearing loss is a common and underserved complication of uncontrolled diabetes. Neuroinflammation in diabetes can cause auditory nerve damage (cochlear synaptopathy) which first translates into speech-in-noise intelligibility deficit. CIL001 is a neurotrophic small molecule that aims to repair auditory nerve when applied locally by transtympanic injection. Transtympanic injection of paliroden is anticipated to improve the symptoms of cochlear synaptopathy. Furthermore, by addressing auditory or vestibular dysfunction early and effectively, this approach may contribute to limiting or delaying, over the long term, the onset of secondary neurological disorders, such as dementia.

Conditions

• Cochlear Synaptopathy

Interventions

Type	Name	Description
DRUG	CIL001 (Paliroden)	Single unilateral transtympanic administration
DRUG	Placebo	Placebo

Timeline

• Start date: 2026-08-01
• Primary completion: 2027-07-01
• Completion: 2027-12-01
• First posted: 2026-03-16
• Last updated: 2026-03-16