A Clinical Study to Assess the Efficacy and Safety of Leriglitazone in Adult Male Subjects With Cerebral Adrenoleukodystrophy
NCT ID: NCT05819866
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
40 participants
INTERVENTIONAL
2023-07-12
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Leriglitazone
Leriglitazone Treatment
Leriglitazone
Leriglitazone at a strength of 15 mg/ml. Once-daily dosing at an initial volume of 10 ml
Placebo
Placebo
Placebo
Placebo will match the study drug visually and by taste
Interventions
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Leriglitazone
Leriglitazone at a strength of 15 mg/ml. Once-daily dosing at an initial volume of 10 ml
Placebo
Placebo will match the study drug visually and by taste
Eligibility Criteria
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Inclusion Criteria
* Subject has progressive cALD, defined as GdE+ brain lesions.
* Subjects for whom HSCT is not recommended by the investigator or subject is not willing to undergo HSCT.
* Subject has a Loes score ≥0.5 and ≤12 at Screening.
* Subject does not have major functional disability in the Major Functional Disabilities-Neurological Function Score (MFD-NFS), except for "wheelchair bound" or "total incontinence", which will be allowed as these are considered expected symptoms of AMN in the time course of the disease
* Subject does not have major cognitive impairment which would impair his ability to take part in the study as determined by the investigator at screening.
Exclusion Criteria
* Subject has known type 1 or type 2 diabetes.
* Subject has known hypersensitivity or intolerance to pioglitazone or any other thiazolidinedione.
* Subject is taking or has taken honokiol, pioglitazone, or other thiazolidinediones within 3 months prior to Screening.
* Subject with current participation in another interventional clinical study or within 1 month prior to Screening.
* Subject with other medical, neuropsychiatric or social conditions that, in the opinion of the investigator, are likely to adversely affect the risk-benefit of study participation, interfere with study compliance, or confound the study results.
18 Years
MALE
No
Sponsors
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Minoryx Therapeutics, S.L.
INDUSTRY
Responsible Party
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Locations
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Stanford University Medical Center
Palo Alto, California, United States
Neuro Medicine Hospital / UF Health
Gainesville, Florida, United States
Kennedy Krieger Institute
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Minnesota
Minneota, Minnesota, United States
Health University of Utah
Salt Lake City, Utah, United States
Hospital Austral
Buenos Aires, , Argentina
Federal University of Sao Paulo
São Paulo, , Brazil
ICM La Pitie Salpetriere
Paris, , France
Klinik und Poliklinik für Neurologie-Leipzig
Leipzig, , Germany
Sir Ganga Ram Hospital
New Delhi, , India
Hospital 12 de Octubre
Madrid, , Spain
National Hospital for Neurology and Neurosurgery
London, , United Kingdom
Countries
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Facility Contacts
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Other Identifiers
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MT-3-01
Identifier Type: -
Identifier Source: org_study_id
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