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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

Evaluation of Miricorilant on Liver Fat in Patients With MASLD

A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Evaluation of Miricorilant on Liver Fat in Patients With MASLD (NCT06947304) is a Phase 1 interventional studying Nonalcoholic Steatohepatitis (NASH) and Metabolic Dysfunction-Associated Steatohepatitis (MASH), sponsored by Corcept Therapeutics. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients with Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Nonalcoholic Steatohepatitis (NASH), a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 8 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - AST \> 17 U/L for women and AST \> 20 U/L for men. The AST inclusion criterion does not apply to participants with an eligible historical liver biopsy performed within 12 months of screening showing one of the following: 1. NAFLD Activity Score (NAS) ≥ 4 (with at least 1 point in each subcomponent of steatosis, inflammation, and ballooning) and NASH Clinical Research Network (CRN) fibrosis score of F0 OR 2. NAS ≥ 3 (with at least 1 point in each subcomponent of steatosis, inflammation, and ballooning) and NASH CRN fibrosis score of F1 OR 3. NAS ≥ 2 (with at least 1 point in subcomponent of ballooning or inflammation) and a NASH CRN fibrosis score of F2-3 - MRI-PDFF with ≥ 8% steatosis; this assessment must be performed within 4 weeks of the Baseline Visit. - Presence of at least 1 of the following metabolic syndrome characteristics that increase the risk of MASH: a. Diagnosis of type 2 diabetes managed with diet alone or diet and metformin (metformin dose must be stable for at least 1 month prior to screening) OR b. Presence of 3 or more components of metabolic syndrome: i. Fasting blood glucose ≥ 100 mg/dL (5.6 mmol/L) or treatment for elevated blood glucose with metformin ii. Systolic blood pressure ≥ 130 mm Hg, diastolic blood pressure ≥ 85 mm Hg, or treatment for hypertension iii. Serum TG ≥ 150 mg/dL (1.7 mmol/L) iv. Serum high-density lipoprotein cholesterol (HDL) \< 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. Having overweight or obesity (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 (men ≥ 90 cm \[35.4 in\]; women ≥ 80 cm \[31.5 in\] in Asians). Other inclusion criteria may apply Who Should NOT Join This Trial: - Participation in another clinical trial for MASH or weight loss (e.g., GLP-1 receptor agonists) within the last 3 months. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * AST \> 17 U/L for women and AST \> 20 U/L for men. The AST inclusion criterion does not apply to participants with an eligible historical liver biopsy performed within 12 months of screening showing one of the following: 1. NAFLD Activity Score (NAS) ≥ 4 (with at least 1 point in each subcomponent of steatosis, inflammation, and ballooning) and NASH Clinical Research Network (CRN) fibrosis score of F0 OR 2. NAS ≥ 3 (with at least 1 point in each subcomponent of steatosis, inflammation, and ballooning) and NASH CRN fibrosis score of F1 OR 3. NAS ≥ 2 (with at least 1 point in subcomponent of ballooning or inflammation) and a NASH CRN fibrosis score of F2-3 * MRI-PDFF with ≥ 8% steatosis; this assessment must be performed within 4 weeks of the Baseline Visit. * Presence of at least 1 of the following metabolic syndrome characteristics that increase the risk of MASH: a. Diagnosis of type 2 diabetes managed with diet alone or diet and metformin (metformin dose must be stable for at least 1 month prior to screening) OR b. Presence of 3 or more components of metabolic syndrome: i. Fasting blood glucose ≥ 100 mg/dL (5.6 mmol/L) or treatment for elevated blood glucose with metformin ii. Systolic blood pressure ≥ 130 mm Hg, diastolic blood pressure ≥ 85 mm Hg, or treatment for hypertension iii. Serum TG ≥ 150 mg/dL (1.7 mmol/L) iv. Serum high-density lipoprotein cholesterol (HDL) \< 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. Having overweight or obesity (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 (men ≥ 90 cm \[35.4 in\]; women ≥ 80 cm \[31.5 in\] in Asians). Other inclusion criteria may apply Exclusion Criteria: * Participation in another clinical trial for MASH or weight loss (e.g., GLP-1 receptor agonists) within the last 3 months. * Participation in any other clinical trial within the last 3 months or 5 half-lives of the treatment, whichever is longer. * Women who are pregnant, planning to become pregnant, or lactating. * BMI \< 18 kg/m² or \> 45 kg/m². * Significant alcohol consumption exceeding 20 g/day for women or 30 g/day for men within 1 year prior to screening. * Positive urine drug screen for amphetamines, cocaine, opiates, or cannabinoids. * Known or suspected cirrhosis or signs of hepatic decompensation. * Other chronic liver diseases such as hepatitis B or C, autoimmune hepatitis, primary biliary cholangitis, or Wilson's disease. * History of myocardial infarction, unstable angina, or stroke within 3 months prior to screening. * Uncontrolled hypertension (systolic \> 160 mm Hg or diastolic \> 100 mm Hg). * Current use of medications prohibited due to potential drug-drug interactions with study treatment. * Contraindications to magnetic resonance imaging (MRI). Other exclusion criteria may apply

Treatments Being Tested

DRUG

Miricorilant

100 mg administered orally, once daily

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University of Missouri
Columbia, Missouri, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06947304), the sponsor (Corcept Therapeutics), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06947304 clinical trial studying?

A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients with Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH) The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06947304?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06947304?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06947304. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06947304. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.