Nonalcoholic Steatohepatitis (NASH)Phase 1NCT06947304
Evaluation of Miricorilant on Liver Fat in Patients With MASLD
A Phase 1 study testing Miricorilant in people with Nonalcoholic Steatohepatitis (NASH) and Metabolic Dysfunction-Associated Steatohepatitis (MASH), run by Corcept Therapeutics at 1 site in United States.
Trial summary
A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients with Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-Associated Steatohepatitis (MASH), Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
- What is being tested?
- Miricorilant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2025to 15 Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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
- NAS ≥ 3 (with at least 1 point in each subcomponent of steatosis, inflammation, and ballooning) and NASH CRN fibrosis score of F1 OR
- 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:
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- 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 cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients with Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Read the detailed description
Approximately 8 patients who are eligible for participation in the study will be assigned to a single dose cohort receiving 100 mg of miricorilant daily. The total duration of participation for each patient is expected to be up to 16 weeks, comprising a 6-week screening period, a 6-week treatment phase, and a 4-week follow-up period.
- Conditions
- Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-Associated Steatohepatitis (MASH), Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), Non-alcoholic Fatty Liver Disease (NAFLD)
- Being tested
- Miricorilant
- Keywords
- Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH), Metabolic dysfunction-Associated Steatohepatitis (MASH), Metabolic dysfunction-Associated Steatosis Liver Disease (MASLD)
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiricorilantDrug
100 mg administered orally, once daily
| Study group | Role | What they receive |
|---|---|---|
| Miricorilant- 100 mg | Experimental | Patients who meet the entry criteria for study CORT118335-858 will be enrolled to receive 100 mg of miricorilant every day for 6 weeks. Receives: Drug: Miricorilant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting hepatic lipogenesis after 6 weeks of treatment
Measured: Baseline to Week 6
Change in peak lipogenesis after 6 weeks of treatment.
Measured: Baseline to Week 6
Secondary outcomes (1)
Change in liver fat content by MRI-PDFF after 6 weeks of treatment
Measured: Baseline to week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start22 Aug 2025
- Primary completion13 Aug 2026
- Study completion15 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Steatohepatitis (NASH)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Missouri-Columbia
- Responsible party
- Sponsor
- Investigators
- Kavita Juneja, MD, Study director, Corcept Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947304
- Sponsor's protocol ID
- CORT118335-858
- Status last verified
- Sep 2026
- First submitted
- 21 Apr 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- ClinicalTrials.gov ID
- NCT06947304
- Acronym / sponsor ID
- CORT118335-858
- Conditions
- Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-Associated Steatohepatitis (MASH), Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), Non-alcoholic Fatty Liver Disease (NAFLD)
- Keywords
- Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH), Metabolic dysfunction-Associated Steatohepatitis (MASH), Metabolic dysfunction-Associated Steatosis Liver Disease (MASLD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- University of Missouri-Columbia
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- 13 Aug 2026 (actual)
- Study completion
- 15 Sep 2026 (actual)
- First posted
- 27 Apr 2025 (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.
A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients with Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Detailed description
Approximately 8 patients who are eligible for participation in the study will be assigned to a single dose cohort receiving 100 mg of miricorilant daily. The total duration of participation for each patient is expected to be up to 16 weeks, comprising a 6-week screening period, a 6-week treatment phase, and a 4-week follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Miricorilant- 100 mg | Experimental | Drug: MiricorilantPatients who meet the entry criteria for study CORT118335-858 will be enrolled to receive 100 mg of miricorilant every day for 6 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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:
- Other inclusion criteria may apply
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| Miricorilant100 mg administered orally, once daily | Drug | Miricorilant- 100 mg |
Primary outcome
Change in fasting hepatic lipogenesis after 6 weeks of treatment
Time frame: Baseline to Week 6
Change in peak lipogenesis after 6 weeks of treatment.
Time frame: Baseline to Week 6
1 secondary outcome
Change in liver fat content by MRI-PDFF after 6 weeks of treatment
Time frame: Baseline to week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 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.
Kavita Juneja, MD study director
Corcept Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Miricorilant in people with Nonalcoholic Steatohepatitis (NASH) and Metabolic Dysfunction-Associated Steatohepatitis (MASH), run by Corcept Therapeutics at 1 site in United States.
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 9 inclusion and 13 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: finished, as of the sponsor's last update on 30 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 1 site in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in fasting hepatic lipogenesis after 6 weeks of treatment (time frame: Baseline to Week 6). The study lists 2 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 30 Sep 2026.