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Dazucorilant in Patients With Amyotrophic Lateral Sclerosis

NCT05407324 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 279

Last updated 2026-03-30

No results posted yet for this study

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

Interventions

DRUG

Dazucorilant 300 mg

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

DRUG

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.

OTHER

Placebo

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

DRUG

Dazucorilant

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

Sponsors & Collaborators

  • Corcept Therapeutics

    lead INDUSTRY

Principal Investigators

  • Sophia Majeed, PharmD, PhD · Corcept Therapeutics Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-15
Primary Completion
2026-09-30
Completion
2027-11-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Ireland
  • Netherlands
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05407324 on ClinicalTrials.gov