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

NCT07472907 | Not Yet Recruiting Phase 1 DMC

• 2 other identifiers: RESPLAND2025-524383-37-00
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

hearing; diabetes

Outcome Measures

Primary Outcomes (1)

• Frequencies of Treatment-Related Adverse Events with a particular focus on ear and auditory symptomatology

  Over 6 month (168 days) post-injection

Secondary Outcomes (5)

• Determine the concentration in plasma of paliroden with Area under the plasma concentration versus time curve (AUC)

  From the day of injection to 28 days

• Determine the concentration in plasma of paliroden with Peak Plasma Concentration (Cmax)

  From the day of injection to 28 days

• Determine the concentration in plasma of paliroden with Time to maximum concentration (Tmax)

  From the day of injection to 28 days

• Change in speech in noise intelligibility base on the SRT50 result From the Matrix test (SRT50 = Signal-to-noise ratio required to correctly understand 50% of presented speech)

  At Day 84 from baseline

• Change in ABR Wave I amplitude (µV) measured by electrocochleography

  Day 28, Day 84, Day 168

Study Arms (2)

CIL001

EXPERIMENTAL

Single Unilateral transtympanic administration

Drug: CIL001 (Paliroden)

Placebo

PLACEBO COMPARATOR

Single Unilateral transtympanic administration

Drug: Placebo

Interventions

CIL001 (Paliroden) DRUG

Single unilateral transtympanic administration

CIL001

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent form
• Aged between 45 and 75 years old (inclusive) at the time of screening
• Established type 2 diabetes as determined by 7% ≤ hemoglobin A1c (HbA1c) ≤ 9% and diabetes duration of at least 5 years
• Be considered as reliable and capable of adhering to the protocol, according to the judgment of the Investigator
• Participants must be native speakers of the official language(s) of the country in which the study assessments are conducted.
• Women of childbearing potential (WOCBP) must have a negative serum pregnancy test upon entry into this study. In addition, they must agree to use highly effective contraception methods, as defined by regulatory guidance (e.g., combined hormonal contraception, intrauterine device, or surgical sterilization), from the screening visit, for the duration of study treatment and for 30 days after dosing.
• The following audiology assessments, if not performed on the same day as the review of the previous criteria (e.g., when the participant's first visit does not take place at the ENT site), may be scheduled on different days within a maximum interval of 14 days after the first screening visit and must be completed at least 21 days before the baseline visit.
• Normal hearing as defined by PTAv (0.5-1-2kHz-4Khz) \<25dB in both ears.
• Up to mild hearing loss in the high-frequency range (PTAvHF (4-6-8kHz) \<40dB) in both ears.
• Speech-in-noise deficit (at least 3dB SNR loss in comparison to normative value of the Matrix test) in both ears.

You may not qualify if:

• MoCA score \< 26
• Known otologic pathology (e.g., History of autoimmune hearing loss, radiation-induced hearing loss, fluctuating hearing, endolymphatic hydrops, or Menière's disease in either ear)
• Presence of middle ear pathology (e.g., otitis media, tympanic membrane perforation, etc.)
• History of platinum-based chemotherapy
• Previous or concurrent malignancies that require treatment and are not clinically stable
• Current evidence or history of retrocochlear pathology (e.g., acoustic neuroma)
• Hearing aids and cochlear implants.
• History of cancer treated by platinum-based chemotherapy.
• Lactation or known pregnancy or positive pregnancy test at both screening and baseline for women of childbearing potential, or planning to become pregnant during the study
• Liver Enzyme Lab Outcomes:
• Bilirubin \> 2 times the upper limit of normal (ULN)
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (AST/ALT) \>5 times ULN.
• Gamma glutamyltransferase (GGT) \> 5 times ULN
• Maternally Inherited Diabetes
• Congenital hearing loss

Sponsors & Collaborators

• Cilcare SAS: lead

MeSH Terms

Conditions

Hearing Loss, Hidden; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel-group, sequential , ascending volume design, two arms, with up to three cohorts

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 16, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-02