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Active, not recruitingNCT05819866CALYXUpdated Jul 29, 2026

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

A Phase 3 interventional study of Leriglitazone and Placebo in Cerebral Adrenoleukodystrophy (cALD), sponsored by Minoryx Therapeutics, S.L.. Active, not recruiting at 11 sites in 8 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by Minoryx Therapeutics, S.L. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study summary

A Clinical Study to Assess the Efficacy and Safety of Leriglitazone in Adults Male Subjects with Cerebral Adrenoleukodystrophy.

02

Conditions studied

  • Cerebral Adrenoleukodystrophy (cALD)

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03

In context

Adrenoleukodystrophy

68 studies on the registry are indexed under Adrenoleukodystrophy; 19 are open to participants now.

This study's planned enrollment of 40 is above the median of 31 across 40 interventional studies indexed under Adrenoleukodystrophy.

Browse Adrenoleukodystrophy studies →

Lead sponsor

Minoryx Therapeutics, S.L. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Subject is male and aged ≥18 years.
  • Subject has progressive cALD, defined as GdE+ brain lesions.
  • Subjects for whom 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.

Key Exclusion Criteria:

  • 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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    Leriglitazone

    Leriglitazone Treatment

    Drug: Leriglitazone

  • Placebo comparator
    Placebo

    Placebo

    Drug: Placebo

Interventions

  • DrugLeriglitazone

    Leriglitazone at a strength of 15 mg/ml. Once-daily dosing at an initial volume of 10 ml

  • DrugPlacebo

    Placebo will match the study drug visually and by taste

06

What researchers measure

Primary outcomes

  1. The primary endpoint will be the time to death or the subject becoming bedridden with a requirement for permanent ventilatory support, wichever comes earlier, in subjects treated with leriglitazone compared to placebo.

    The primary endpoint will be the time to death or the subject becoming bedridden with a requirement for permanent ventilatory support, wichever comes earlier, in subjects treated with leriglitazone compared to placebo.

    Time frame: Interim analysis 1 (at 18 months of treatment)

  2. The primary endpoint will be the time to death or the subject becoming bedridden with a requirement for permanent ventilatory support, wichever comes earlier, in subjects treated with leriglitazone compared to placebo.

    The primary endpoint will be the time to death or the subject becoming bedridden with a requirement for permanent ventilatory support, wichever comes earlier, in subjects treated with leriglitazone compared to placebo.

    Time frame: Interim analysis 2 (at 27 months of treatment)

  3. The primary endpoint will be the time to death or the subject becoming bedridden with a requirement for permanent ventilatory support, wichever comes earlier, in subjects treated with leriglitazone compared to placebo.

    The primary endpoint will be the time to death or the subject becoming bedridden with a requirement for permanent ventilatory support, wichever comes earlier, in subjects treated with leriglitazone compared to placebo.

    Time frame: Final analysis (at 36 months of treatment)

Secondary outcomes

  1. Change from Baseline in Loes Score.

    Change from Baseline in Loes Score. Loes Score Minimum = 0 Maximum =34 0 better outcome (healthy) 34 worst osutcome

    Time frame: Interim analysis 1 (at 18 months of treatment)

  2. Change from Baseline in Loes Score

    Change from Baseline in Loes Score. Loes Score Minimum = 0 Maximum =34 0 better outcome (healthy) 34 worst osutcome

    Time frame: Interim analysis 2 (at 27 months of treatment)

  3. Change from Baseline in Loes Score

    Change from Baseline in Loes Score. Loes Score Minimum = 0 Maximum =34 0 better outcome (healthy) 34 worst osutcome

    Time frame: Final analysis (at 36 months of treatment)

07

Study locations

11 sites
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05819866
Lead sponsor
Minoryx Therapeutics, S.L.
Responsible party
Sponsor
First posted
Apr 19, 2023
Start date
Jul 12, 2023
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Jul 29, 2026

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Leriglitazone

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