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Dazucorilant for Amyotrophic Lateral Sclerosis (ALS)

This study is testing a drug called dazucorilant for people with Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease. Researchers want to see if dazucorilant is safe and if it can help improve daily function for people with ALS. You might receive 300 mg of dazucorilant, 150 mg of dazucorilant, or a placebo (an inactive substance that looks like the study drug). The study will measure changes in your ALS Functional Rating Scale-Revised (ALSFRS-R) score, which assesses your ability to perform daily tasks, and track any side effects. This study is currently recruiting adults aged 18 and older with sporadic or familial ALS.

Study design
This study has two parts. In Part 1, about 279 participants will be randomly assigned to one of three groups (dazucorilant 300 mg, dazucorilant 150 mg, or placebo) for 24 weeks, and neither you nor your doctor will know which treatment you are receiving (double-blind).
What's involved
In Part 1, you would participate in a 24-week treatment period. If you complete this, you may be eligible for an open-label extension study lasting 132 weeks, or a 132-week follow-up period.
Compensation
Not stated in the trial record.
Follow-up
Participants who complete the double-blind treatment period and do not enter the open-label extension will enter a 132-week follow-up period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05407324

Dazucorilant in Patients With Amyotrophic Lateral Sclerosis

Recruiting
PHASE2Ages 18+InterventionalTreatment
Corcept Therapeutics
~279 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:Dazucorilant 300 mgDazucorilant 150 mgPlaceboDazucorilant

At a glance

Recruiting sites
6 of 35 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline to Week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R) total score.
Measured over Baseline to Week 24
+3 more outcomes measured

Conditions

Amyotrophic Lateral Sclerosis

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Where you'd take part

This study runs at 35 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • 062

    Phoenix, Arizonano site contact published

    Recruiting

  • 264

    Utrecht, Netherlandsno site contact published

    Recruiting

  • 270

    Bonn, Germanyno site contact published

    Recruiting

  • 278

    San Francisco, Californiano site contact published

    Recruiting

  • 287

    Neptune City, New Jerseyno site contact published

    Recruiting

  • 353

    New York, New Yorkno site contact published

    Recruiting

  • 108

    Leuven, Belgiumno site contact published

    Active, not recruiting

  • 115

    Barcelona, Spainno site contact published

    Active, not recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Sophia Majeed, PharmD, PhD · STUDY_DIRECTOR · Corcept Therapeutics Incorporated

Who to contact

Clinical Trial Lead
[email protected]
(650) 249-9965 · ext. +1
Email the study team

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Eligibility criteria

Inclusion

Male and female patients ≥18 years of age with sporadic or familial ALS. In Part 1, patients must have a risk of ALS progression characterized by a European Network for the Cure of ALS (ENCALS) risk profile score ≥ -6 and ≤ -3. In Part 2 patients must have a risk of ALS progression characterized by an Treatment Research Initiative to Cure ALS (TRICALS) risk profile score ≥ -7 and ≤ -3.
If taking riluzole, edaravone, and/or sodium phenylbutyrate and taurursodiol, must be on a stable dose prior to Screening. Sodium phenylbutyrate and taurursodiol are not permitted for patients enrolled in Part 2 of the study.
Part 2 only: Patients with a pathogenic mutation in superoxide dismutase 1 gene (SOD1) must not be receiving treatment with tofersen or eligible for treatment with tofersen if available. Patients who have received prior treatment with tofersen and discontinued due to safety and/or efficacy reasons prior to Screening are eligible.
Part 2 only: Use of ultra high-dose methylcobalamin for the treatment of ALS is permitted provided the patient has been on a stable dose for ≥11 weeks prior to the Day 1 visit.

Exclusion

History of a clinically significant non-ALS neurologic disorder
Inability to swallow capsules.
Blood platelet count \<150,000/mm\^3.
Renal impairment indicated by Estimated Glomerular Filtration Rate (eGFR) ≤30 mL/min/1.73 m\^2. Part 2 only: Patients with a recent history of acute kidney injury should have returned to their baseline renal function (i.e, eGFR prior to acute kidney injury) prior to enrollment.
Human immunodeficiency virus (HIV) or current chronic/active infection with hepatitis C virus or hepatitis B virus. Part 2 only: Known history of HIV or chronic/active infection with hepatitis C or hepatitis B virus; testing does not need to be performed if infection status is unknown.
Women who are pregnant, planning to become pregnant, or are breastfeeding.
Use of non-invasive ventilation (NIV) or mechanical ventilation via tracheostomy, or on any form of oxygen supplementation.
Cancer that is currently being treated (except adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin, stage I endometrial cancer or carcinoma in situ of the cervix or breast) or a history of cancer with an expected survival \< 2 years.
Current or anticipated need of a diaphragm pacing system (DPS).
Previous exposure or treatment with glucocorticoid receptor modulators or antagonists.
Taking, or have taken, any systemic, inhaled, or potent dermatologic topical corticosteroids (Class I to III) within a period equivalent to 5 half-lives of the corticosteroid used prior to first dose of study drug. Patients who have stopped glucocorticoid use should have an alternative option if their condition deteriorates during the study.

What this trial measures

  • Change from Baseline to Week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R) total score.Baseline to Week 24

    This outcome measure is assessed in study Part 1.

  • Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, AEs by severity, and deaths due to AEsBaseline to Week 24

    This outcome measure is assessed in study Part 1.

  • Incidence of treatment-emergent AEs and SAEsBaseline up to Week 12

    This outcome measure is assessed in study Part 2.

  • Incidence of treatment-emergent AEs leading to dose interruptions, dose reductions, and/or discontinuations of study drugBaseline up to Week 12

    This outcome measure is assessed in study Part 2.