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Dazucorilant treatment for people with ALS.

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety and Efficacy of CORT113176 (Dazucorilant) in Patients With Amyotrophic Lateral Sclerosis (DAZALS)

Phase 2 Interventional Corcept Therapeutics · NCT05407324

This trial will test whether dazucorilant is safe and helps adults with ALS by comparing two doses with placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment279 (estimated)
Ages18 Years and up
SexAll
SponsorCorcept Therapeutics Industry-sponsored
Locations35 sites (Phoenix, Arizona and 34 other locations)
Trial IDNCT05407324 on ClinicalTrials.gov

What this trial studies

In Part 1, adults with ALS are randomized 1:1:1 to dazucorilant 150 mg, dazucorilant 300 mg, or placebo for a 24-week double-blind period across sites in North America and Europe. Patients who complete the double-blind period may enter a 132-week open-label extension at 300 mg once daily, while those who do not enter the extension will have a 132-week follow-up. Part 2 uses an open-label dose-titration design starting at 75 mg daily and increasing in 75 mg increments to a 300 mg target dose to evaluate tolerability, with a 52-week open-label extension for completers. The study focuses on safety, tolerability, and potential effects on disease progression in people meeting specific ENCALS risk-score criteria.

Who should consider this trial

Good fit: Adults (≥18) with sporadic or familial ALS who meet the trial's ENCALS risk-score range and are on stable doses of approved ALS medications are the intended participants, with Part 2 including additional exclusions related to certain therapies and SOD1 treatment status.

Not a fit: Patients with very advanced disease outside the ENCALS eligibility window, those receiving disallowed therapies (for example, tofersen in Part 2), or those with major comorbidities may be unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, dazucorilant could slow ALS progression or help stabilize motor function for some patients.

How similar studies have performed: This mechanism and compound represent a relatively novel approach in ALS, and there are limited prior clinical data showing clear disease-modifying benefit for similar strategies.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 ENCALS 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 Criteria:

* 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 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.
* Current or anticipated need of a diaphragm pacing system (DPS).
* Currently using glucocorticoids or have a history of regular systemic glucocorticoid use within the last 12 months.
* Previous exposure or treatment with glucocorticoid receptor modulators or antagonists.

Where this trial is running

Phoenix, Arizona and 34 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Amyotrophic Lateral SclerosisALS, Amyotrophic Lateral Sclerosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.