A Clinical Study to Assess the Efficacy and Safety of Leriglitazone in Adult Male Subjects With Cerebral Adrenoleukodystrophy

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 groups

Sponsors and collaborators