ConditionCerebral Adrenoleukodystrophy (cALD)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorMinoryx Therapeutics, S.L.
About this trial
A Clinical Study to Assess the Efficacy and Safety of Leriglitazone in Adults Male Subjects with Cerebral Adrenoleukodystrophy.
Eligibility criteria
Qualifiers
Subject is male and aged ≥18 years.
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.
Disqualifiers
Subject who had previous bone marrow transplantation (HSCT) or treatment with ex-vivo gene therapy (eli-Cel).
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.
Trial design
Treatments tested in this trial
- Leriglitazone
- Placebo
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov