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New hope for ALS: experimental drug aims to slow muscle decline

NCT ID NCT05407324

Disease control Sponsor: Corcept Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug, dazucorilant, in 279 adults with ALS (Lou Gehrig's disease). The goal is to see if the drug can slow the loss of muscle function and improve quality of life over 24 weeks. Participants will receive either the drug or a placebo, and researchers will monitor safety and changes in daily abilities.

Why investors are watching

Corcept Therapeutics is running a phase 2 trial of its drug dazucorilant in 279 people with ALS, a disease with no cure. For a small company, this readout is a major test of whether the drug can slow the disease, and the result will shape investor views on the company's pipeline.

If it works: A positive result could show that dazucorilant helps ALS patients, which would strengthen Corcept's position in developing treatments for a serious disease. That outcome could lead to larger trials and broader interest in the drug.

If it fails: ALS trials often fail, and a negative or unclear result would likely hurt the company's prospects for this drug. A delay in the trial could also push back any potential progress and disappoint investors waiting for news.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 279 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amyotrophic lateral sclerosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    6 sites in 3 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • 062

    RECRUITING

    Phoenix, Arizona, 85013, United States

  • 108

    ACTIVE_NOT_RECRUITING

    Leuven, 3000, Belgium

  • 115

    ACTIVE_NOT_RECRUITING

    Barcelona, 08035, Spain

  • 194

    ACTIVE_NOT_RECRUITING

    Valencia, 46026, Spain

  • 253

    ACTIVE_NOT_RECRUITING

    Dublin, D09 YD60, Ireland

  • 254

    ACTIVE_NOT_RECRUITING

    Warsaw, 01-684, Poland

  • 255

    ACTIVE_NOT_RECRUITING

    Berlin, 13353, Germany

  • 256

    ACTIVE_NOT_RECRUITING

    Tours, 37000, France

  • 257

    ACTIVE_NOT_RECRUITING

    Limoges, 87042, France

  • 258

    ACTIVE_NOT_RECRUITING

    Lille, 59037, France

  • 259

    ACTIVE_NOT_RECRUITING

    Nice, 06001, France

  • 260

    ACTIVE_NOT_RECRUITING

    Hanover, 30625, Germany

  • 261

    ACTIVE_NOT_RECRUITING

    Marseille, 13385, France

  • 262

    ACTIVE_NOT_RECRUITING

    Paris, 75651, France

  • 263

    ACTIVE_NOT_RECRUITING

    Stoke-on-Trent, ST4 6QG, United Kingdom

  • 264

    RECRUITING

    Utrecht, 3584 CW, Netherlands

  • 265

    ACTIVE_NOT_RECRUITING

    Jena, 7747, Germany

  • 267

    ACTIVE_NOT_RECRUITING

    Rostock, 18147, Germany

  • 268

    ACTIVE_NOT_RECRUITING

    Dresden, 1307, Germany

  • 269

    ACTIVE_NOT_RECRUITING

    Ulm, 89081, Germany

  • 270

    RECRUITING

    Bonn, 53127, Germany

  • 273

    ACTIVE_NOT_RECRUITING

    Montreal, Quebec, H3A2B4, Canada

  • 274

    ACTIVE_NOT_RECRUITING

    Warsaw, 02-473, Poland

  • 278

    RECRUITING

    San Francisco, California, 94109, United States

  • 282

    ACTIVE_NOT_RECRUITING

    Málaga, 29010, Spain

  • 283

    ACTIVE_NOT_RECRUITING

    Bydgoszcz, 85-163, Poland

  • 287

    RECRUITING

    Neptune City, New Jersey, 07753, United States

  • 302

    ACTIVE_NOT_RECRUITING

    Barcelona, 08003, Spain

  • 303

    ACTIVE_NOT_RECRUITING

    Madrid, 28046, Spain

  • 353

    RECRUITING

    New York, New York, 10032, United States

  • 385

    ACTIVE_NOT_RECRUITING

    Krakow, 30721, Poland

  • 386

    ACTIVE_NOT_RECRUITING

    München, 81675, Germany

  • 422

    ACTIVE_NOT_RECRUITING

    Bron, 69500, France

  • 423

    ACTIVE_NOT_RECRUITING

    Montpellier, 42395, France

  • 425

    ACTIVE_NOT_RECRUITING

    Hamilton, Ontario, L8N 3Z5, Canada

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