Amyotrophic Lateral SclerosisPhase 2DAZALSNCT05407324
Dazucorilant in Patients With Amyotrophic Lateral Sclerosis
A Phase 2 study testing Dazucorilant 300 mg, Dazucorilant 150 mg and Dazucorilant in people with Amyotrophic Lateral Sclerosis, run by Corcept Therapeutics at 35 sites in 10 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Dazucorilant 300 mg, Dazucorilant 150 mg and Dazucorilant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 279 participants
- Where
- 35 sitesin 10 countries
- Study dates
- 15 Nov 2022to Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
35 sites in 10 countries.
35 sites in 10 countries
France8 sites
422
Bron, 69500
258
Lille, 59037
257
Limoges, 87042
261
Marseille, 13385
423
Montpellier, 42395
259
Nice, 06001
262
Paris, 75651
256
Tours, 37000
Germany8 sites
255
Berlin, 13353
270
Bonn, 53127
268
Dresden, 1307
260
Hanover, 30625
265
Jena, 7747
386
München, 81675
267
Rostock, 18147
269
Ulm, 89081
Spain5 sites
302
Barcelona, 08003
115
Barcelona, 08035
303
Madrid, 28046
282
Málaga, 29010
194
Valencia, 46026
United States4 sites
287
Neptune City, New Jersey, 07753
353
New York, New York, 10032
062
Phoenix, Arizona, 85013
278
San Francisco, California, 94109
Poland4 sites
283
Bydgoszcz, 85-163
385
Krakow, 30721
254
Warsaw, 01-684
274
Warsaw, 02-473
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety and Efficacy of CORT113176 (Dazucorilant) in Patients With Amyotrophic Lateral Sclerosis (DAZALS)
The purpose of this 2-part study is to assess the safety and efficacy of CORT113176 (dazucorilant) in patients with Amyotrophic Lateral Sclerosis (ALS).
Read the detailed description
In Part 1, eligible ALS patients will be randomized to one of three treatment arms (1:1:1) across North America and Europe for a 24-week double-blind treatment period. Patients who complete participation (i.e., complete all visits) in the double-blind treatment period will be eligible for participation in a 132-week open-label extension (OLE) study. A daily dose of 300 mg dazucorilant will be used in the OLE period. Patients who complete the double-blind treatment period and who do not enter the OLE will enter the 132-week follow-up period.
In Part 2, eligible ALS patients will receive open-label treatment to evaluate dose titration and tolerability of dazucorilant. The dose titration will begin with an initial 75 mg once daily dose, and the dose will be titrated up as tolerated in 75 mg increments until the 300 mg once daily target dose is reached and maintained for 3 weeks. Patients who complete participation in the dose-titration treatment period will be eligible to continue treatment with dazucorilant 300 mg once daily in a 52-week open-label extension portion of the study.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Dazucorilant 300 mg, Dazucorilant 150 mg, Placebo, Dazucorilant
- Keywords
- ALS, Amyotrophic Lateral Sclerosis
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dazucorilant 300 mgDrug
Also called CORT113176
300 mg of dazucorilant will be administered once daily in 4 capsules of 75 mg dazucorilant/capsule.
Dazucorilant 150 mgDrug
Also called CORT113176
Dazucorilant and placebo will be administered once daily in 4 capsules, 2 capsules with 75 mg dazucorilant/capsule, and 2 capsules of placebo equivalent.
PlaceboOther
Placebo will be administered once daily in capsules of placebo equivalent.
DazucorilantDrug
Also called CORT113176
Dazucorilant will be administered once daily in 75-mg capsules.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: CORT113176 (Dazucorilant) 300 mg | Experimental | 300 mg of dazucorilant will be administered once daily. Receives: Drug: Dazucorilant 300 mg |
| Part 1: CORT113176 (Dazucorilant) 150 mg | Experimental | 150 mg of dazucorilant will be administered once daily. Receives: Drug: Dazucorilant 150 mg; Other: Placebo |
| Part 1: Placebo (matched to study drug) | Placebo comparator | Placebo will be administered once daily. Receives: Other: Placebo |
| Part 2: CORT113176 (Dazucorilant) 75 - 300 mg Dose-titration | Experimental | 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. Receives: Drug: Dazucorilant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to Week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R) total score.
This outcome measure is assessed in study Part 1.
Measured: Baseline to Week 24
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, AEs by severity, and deaths due to AEs
This outcome measure is assessed in study Part 1.
Measured: Baseline to Week 24
Incidence of treatment-emergent AEs and SAEs
This outcome measure is assessed in study Part 2.
Measured: Baseline up to Week 12
Incidence of treatment-emergent AEs leading to dose interruptions, dose reductions, and/or discontinuations of study drug
This outcome measure is assessed in study Part 2.
Measured: Baseline up to Week 12
Secondary outcomes (4)
Change from Baseline to Week 24 in muscle strength (assessed using hand-held dynamometer)
This outcome measure is assessed in study Part 1.
Measured: Baseline to Week 24
Change from Baseline to Week 24 in Percent Slow Vital Capacity
This outcome measure is assessed in study Part 1.
Measured: Baseline to Week 24
Change from Baseline to Week 24 in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
This outcome measure is assessed in study Part 1.
Measured: Baseline to Week 24
Time to Death
This outcome measure is assessed in study Part 1.
Measured: From randomization date to the date of death from any cause up to 156 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start15 Nov 2022
- Primary completionOct 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 279 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sophia Majeed, PharmD, PhD, Study director, Corcept Therapeutics Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407324
- Sponsor's protocol ID
- CORT113176-652
- Other IDs
- 2021-005611-31
- Acronym
- DAZALS
- Status last verified
- Sep 2026
- First submitted
- 2 Jun 2022
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety and Efficacy of CORT113176 (Dazucorilant) in Patients With Amyotrophic Lateral Sclerosis (DAZALS)
- ClinicalTrials.gov ID
- NCT05407324
- Acronym / sponsor ID
- DAZALS / CORT113176-652
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- ALS, Amyotrophic Lateral Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 279 participants (estimated)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this 2-part study is to assess the safety and efficacy of CORT113176 (dazucorilant) in patients with Amyotrophic Lateral Sclerosis (ALS).
Detailed description
In Part 1, eligible ALS patients will be randomized to one of three treatment arms (1:1:1) across North America and Europe for a 24-week double-blind treatment period. Patients who complete participation (i.e., complete all visits) in the double-blind treatment period will be eligible for participation in a 132-week open-label extension (OLE) study. A daily dose of 300 mg dazucorilant will be used in the OLE period. Patients who complete the double-blind treatment period and who do not enter the OLE will enter the 132-week follow-up period.
In Part 2, eligible ALS patients will receive open-label treatment to evaluate dose titration and tolerability of dazucorilant. The dose titration will begin with an initial 75 mg once daily dose, and the dose will be titrated up as tolerated in 75 mg increments until the 300 mg once daily target dose is reached and maintained for 3 weeks. Patients who complete participation in the dose-titration treatment period will be eligible to continue treatment with dazucorilant 300 mg once daily in a 52-week open-label extension portion of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: CORT113176 (Dazucorilant) 300 mg | Experimental | Drug: Dazucorilant 300 mg300 mg of dazucorilant will be administered once daily. |
| Part 1: CORT113176 (Dazucorilant) 150 mg | Experimental | Drug: Dazucorilant 150 mg, Other: Placebo150 mg of dazucorilant will be administered once daily. |
| Part 1: Placebo (matched to study drug) | Placebo comparator | Other: PlaceboPlacebo will be administered once daily. |
| Part 2: CORT113176 (Dazucorilant) 75 - 300 mg Dose-titration | Experimental | Drug: Dazucorilant75 mg of dazucorilant will be administered once daily for 1 week, and increased weekly in 75 mg increments up to 300 mg once daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dazucorilant 300 mgAlso: CORT113176300 mg of dazucorilant will be administered once daily in 4 capsules of 75 mg dazucorilant/capsule. | Drug | Part 1: CORT113176 (Dazucorilant) 300 mg |
| Dazucorilant 150 mgAlso: CORT113176Dazucorilant and placebo will be administered once daily in 4 capsules, 2 capsules with 75 mg dazucorilant/capsule, and 2 capsules of placebo equivalent. | Drug | Part 1: CORT113176 (Dazucorilant) 150 mg |
| PlaceboPlacebo will be administered once daily in capsules of placebo equivalent. | Other | Part 1: CORT113176 (Dazucorilant) 150 mg, Part 1: Placebo (matched to study drug) |
| DazucorilantAlso: CORT113176Dazucorilant will be administered once daily in 75-mg capsules. | Drug | Part 2: CORT113176 (Dazucorilant) 75 - 300 mg Dose-titration |
Primary outcome
Change from Baseline to Week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R) total score.
Time frame: 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 AEs
Time frame: Baseline to Week 24
This outcome measure is assessed in study Part 1.
Incidence of treatment-emergent AEs and SAEs
Time frame: Baseline 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 drug
Time frame: Baseline up to Week 12
This outcome measure is assessed in study Part 2.
4 secondary outcomes
Change from Baseline to Week 24 in muscle strength (assessed using hand-held dynamometer)
Time frame: Baseline to Week 24
Change from Baseline to Week 24 in Percent Slow Vital Capacity
Time frame: Baseline to Week 24
Change from Baseline to Week 24 in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
Time frame: Baseline to Week 24
Time to Death
Time frame: From randomization date to the date of death from any cause up to 156 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophia Majeed, PharmD, PhD study director
Corcept Therapeutics Incorporated
35 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dazucorilant 300 mg, Dazucorilant 150 mg and Dazucorilant in people with Amyotrophic Lateral Sclerosis, run by Corcept Therapeutics at 35 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in France, Germany, Spain, United States, Poland and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.