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New drug shows promise against fatty liver disease in Mid-Stage trial

NCT ID NCT06108219

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 called miricorilant in 175 adults with nonalcoholic steatohepatitis (NASH), a serious fatty liver disease. Participants are randomly assigned to receive either the drug or a placebo, and researchers measure changes in liver fat using MRI scans over 24 to 48 weeks. The goal is to see if miricorilant can safely reduce liver fat and improve liver health.

Why investors are watching

Corcept Therapeutics is running a Phase 2b trial of miricorilant in patients with nonalcoholic steatohepatitis, a common liver disease. For a small company, this mid-stage readout is a major test of whether the drug can treat the condition better than a placebo. The result will help investors judge the drug's commercial potential.

If it works: A positive result could show miricorilant works and is safe, which might support further development and eventual approval. That would give Corcept a new product in a large patient population.

If it fails: The trial could fail to show miricorilant beats placebo, or safety problems could emerge. Many Phase 2 trials fail, and a negative result would likely hurt the company's prospects for this drug.

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

175 people

The number who actually took part.

Started

Oct 2023

Expected to finish

Sep 2026

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 to 75 years

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: * Cohort A: Histological diagnosis of NASH/MASH with NAS ≥ 4 (≥ 1 point in each subcomponent of steatosis, inflammation, and ballooning) and NASH-CRN fibrosis score of 2 or 3 based on the consensus method of histological assessment. A historical liver biopsy within 6 months of Screening with reading confirmed during the Screening period by a consensus panel is acceptable. * Cohort B: Have a liver biopsy result that does not meet with the criteria for inclusion in Cohort A and is consistent with one of the following based on the consensus method of histological assessment: * NAS ≥ 3 with ≥1 point in each subcomponent of steatosis, inflammation, and ballooning, and a NASH-CRN fibrosis score of F1 or * NAS ≥ 2 with ≥1 point in subcomponent of steatosis and ≥ 1 point in subcomponent of ballooning or inflammation and a NASH-CRN fibrosis score of F2 or 3 * AST \> 17 U/L for women and AST \> 20 U/L for men. * FibroScan® liver stiffness measurement ≥ 8 kPa and CAP ≥ 280 dB/m. * MRI-PDFF with ≥ 8% steatosis * Presence of at least 1 of the following metabolic syndromes that increase the risk of NASH/MASH: 1. Diagnosis of type 2 diabetes OR 2. Presence of 2 or more components of metabolic syndrome: i. Fasting blood glucose ≥ 100 mg/dL (5.6 mmol/L) or treatment for elevated blood glucose ii. Systolic blood pressure ≥ 130mmHg, diastolic blood pressure ≥ 85mmHg, or treatment for hypertension iii. Serum triglycerides ≥ 150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides iv. Serum high-density lipoprotein (HDL) cholesterol \< 40 mg/dL (1 mmol/L) in men and \< 50 mg/dL (1.3 mmol/L) in women or drug treatment for low HDL v. Overweight or obese (body mass index \[BMI\] ≥ 25 kg/m2 \[BMI ≥ 23 kg/m2 in Asians\]), or increased waist circumference ≥ 102 cm (40 in) in men and ≥ 88 cm (35 in) in women (male ≥ 90 cm \[35.4 in\]; women ≥ 80 cm \[31.5 in\] in * Other inclusion criteria may apply Exclusion Criteria: * Have participated in another clinical trial within the last 3 months of Screening where the patient received active treatment for NASH/MASH. * Have participated in a clinical trial for any other indication within the last 3 months or 5 half-lives of the treatment, whichever is longer. * Are pregnant or lactating women * Have a BMI \< 18 kg/m2 or \> 45 kg/m2.• Have had liver transplantation or plan to have liver transplantation during the study * Have type 1 diabetes or poorly controlled type 2 diabetes. * Are pregnant or lactating women * Have a BMI \< 18 kg/m2 or \> 45 kg/m2 * Have had successful weight-loss surgery within 2 years prior to Screening or are planning weight-loss surgery during the study. * Have a \>5% weight change within 3 months prior to Screening. * Have significant alcohol consumption of more than 20 g per day for women and 30 g per day for men within 1 year prior to screening or score of ≥8 on AUDIT questionnaire * Have any other chronic liver disease * History of cirrhosis or evidence of cirrhosis by clinical, imaging, or liver biopsy evaluation * Have hepatic decompensation * Other exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

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

Metabolic dysfunction associated steatohepatitis (MASH) Nonalcoholic steatohepatitis (NASH)

Contacts and locations

Locations

  • Site # 066

    Houston, Texas, 77030, United States

  • Site # 101

    Gainesville, Florida, 32610, United States

  • Site # 485

    Jaipur, Rajasthan, 302004, India

  • Site # 494

    Rohtak, Haryana, 124001, India

  • Site # 546

    Arlington, Texas, 76012, United States

  • Site #061

    Metairie, Louisiana, 70006, United States

  • Site #207

    Chandler, Arizona, 85224, United States

  • Site #209

    Tucson, Arizona, 85712, United States

  • Site #211

    Austin, Texas, 78757, United States

  • Site #212

    San Antonio, Texas, 78229, United States

  • Site #213

    Edinburg, Texas, 78539, United States

  • Site #214

    Panorama City, California, 91402, United States

  • Site #215

    Edinburg, Texas, 78539, United States

  • Site #226

    Seattle, Washington, 98105, United States

  • Site #228

    Kansas City, Missouri, 64131, United States

  • Site #233

    Santa Ana, California, 92704, United States

  • Site #305

    Houston, Texas, 77079, United States

  • Site #370

    Dallas, Texas, 75230, United States

  • Site #373

    Los Angeles, California, 90056, United States

  • Site #378

    Huntington Park, California, 90255, United States

  • Site #430

    Hialeah Gardens, Florida, 33016, United States

  • Site #431

    Georgetown, Texas, 78626, United States

  • Site #432

    Brownsville, Texas, 78520, United States

  • Site #433

    San Antonio, Texas, 78125, United States

  • Site #434

    Waco, Texas, 78125, United States

  • Site #437

    Westlake, Ohio, 44145, United States

  • Site #438

    Miami Lakes, Florida, 33016, United States

  • Site #439

    Lancaster, California, 93534, United States

  • Site #440

    Rockville, Maryland, 20854, United States

  • Site #441

    West Jordan, Utah, 84088, United States

  • Site #442

    Saint Paul, Minnesota, 55114, United States

  • Site #445

    East Syracuse, New York, 13057, United States

  • Site #447

    Beavercreek, Ohio, 45440, United States

  • Site #448

    Dayton, Ohio, 45145, United States

  • Site #451

    Marrero, Louisiana, 70072, United States

  • Site #452

    Boca Raton, Florida, 33434, United States

  • Site #453

    Houma, Louisiana, 70363, United States

  • Site #454

    New York, New York, 10033, United States

  • Site #455

    Jackson, New Jersey, 08724, United States

  • Site #457

    San Juan, 00927-4807, Puerto Rico

  • Site #458

    Lakewood Rch, Florida, 38018, United States

  • Site #459

    Katy, Texas, 77494, United States

  • Site #460

    Viera, Florida, 32940, United States

  • Site #461

    Cordova, Tennessee, 38018, United States

  • Site #463

    Manassas, Virginia, 20110, United States

  • Site #464

    Morehead City, North Carolina, 29557, United States

  • Site #465

    Hallandale, Florida, 33009, United States

  • Site #469

    Long Beach, California, 90815, United States

  • Site #470

    Columbus, Ohio, 43234, United States

  • Site #475

    Largo, Florida, 33777, United States

  • Site #482

    New Delhi, 110029, India

  • Site #486

    Hyderabad, Telangana, 500003, India

  • Site #487

    Kolkata, West Bengal, 700020, India

  • Site #488

    Varanasi, Uttar Pradesh, 221005, India

  • Site #489

    Jaipur, Rajasthan, 302001, India

  • Site #490

    Surat, Gujarat, 395009, India

  • Site #491

    Kolkata, West Bengal, 700150, India

  • Site #492

    Ahmedabad, Gujarat, 380053, India

  • Site #493

    Kolkata, West Bengal, 700073, India

  • Site #495

    Ludhiana, Punjab, 141002, India

  • Site #496

    Pune, Maharashtra, 412201, India

  • Site #500

    Nagpur, Maharashtra, 440009, India

  • Site #501

    New Delhi, 110070, India

  • Site #502

    Vadodara, Gujarat, 390007, India

  • Site #503

    Varanasi, Uttar Pradesh, 221005, India

  • Site #504

    Dehradun, Uttarakhand, 248001, India

  • Site #506

    Guwahati, Assam, 781032, India

  • Site #507

    Thiruvananthapuram, Kerala, 695011, India

  • Site #508

    Madurai, Tamil Nadu, 625020, India

  • Site #509

    Mumbai, Maharashtra, 400062, India

  • Site #510

    New Delhi, 110060, India

  • Site #511

    Mysore, Karnataka, 570015, India

  • Site #512

    Mumbai, Maharashtra, 400008, India

  • Site #513

    Rajkot, Gujarat, 360001, India

  • Site #514

    Surat, Gujarat, 395009, India

  • Site #545

    Austin, Texas, 78756, United States

  • Site #549

    Lucknow, Uttar Pradesh, 226003, India

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Other studies related to the condition(s) this trial covers.