Recruiting
Phase 2

CORT113176

Sponsor:

Corcept Therapeutics

Code:

NCT05407324

Conditions

Amyotrophic Lateral Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dazucorilant 300 mg

Dazucorilant 150 mg

Placebo

Dazucorilant

Study Details

Brief summary:

The purpose of this 2-part study is to assess the safety and efficacy of CORT113176 (dazucorilant) in patients with Amyotrophic Lateral Sclerosis (ALS).

Conditions

Amyotrophic Lateral Sclerosis

Study ID

NCT05407324

Start date

Nov 15, 2022

Status verified date

Jun, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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 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 (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.

Study Design

Enrollment

279 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: CORT113176 (Dazucorilant) 300 mg

300 mg of dazucorilant will be administered once daily.

experimental: Part 1: CORT113176 (Dazucorilant) 150 mg

150 mg of dazucorilant will be administered once daily.

placebo comparator: Part 1: Placebo (matched to study drug)

Placebo will be administered once daily.

experimental: Part 2: CORT113176 (Dazucorilant) 75 - 300 mg Dose-titration

75 mg of dazucorilant will be administered once daily for 1 week, and increased weekly in 75 mg increments up to 300 mg once daily.

Interventions

Dazucorilant 300 mg

300 mg of dazucorilant will be administered once daily in 4 capsules of 75 mg dazucorilant/capsule.

Dazucorilant 150 mg

Dazucorilant and placebo will be administered once daily in 4 capsules, 2 capsules with 75 mg dazucorilant/capsule, and 2 capsules of placebo equivalent.

Placebo

Placebo will be administered once daily in capsules of placebo equivalent.

Dazucorilant

Dazucorilant will be administered once daily in 75-mg capsules.

Primary outcome measure

  • Change from Baseline to Week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R) total score. [ Time Frame: Baseline to Week 24 ]
  • Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, AEs by severity, and deaths due to AEs [ Time Frame: Baseline to Week 24 ]
  • Incidence of treatment-emergent AEs and SAEs [ Time Frame: Baseline up to Week 12 ]
  • Incidence of treatment-emergent AEs leading to dose interruptions, dose reductions, and/or discontinuations of study drug [ Time Frame: Baseline up to Week 12 ]

Central Contacts and Locations

Central contacts

Clinical Trial Lead

(650) 249-9965study652@corcept.com

Locations

062

Recruiting

Phoenix, Arizona, United States, 85013

278

Recruiting

San Francisco, California, United States, 94109

287

Recruiting

Neptune City, New Jersey, United States, 07753

353

Recruiting

New York, New York, United States, 10032

More Information

Sponsor

Corcept Therapeutics

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Keywords

  • ALS, Amyotrophic Lateral Sclerosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Corcept Therapeutics on 2026-06-16.