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Corticosteroid
Miricorilant for Non-Alcoholic Steatohepatitis
Phase 2
Recruiting
Research Sponsored by Corcept Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histological diagnosis of NASH 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.
i. Fasting blood glucose ≥ 100 mg/dL (5.6 mmol/L) or treatment for elevated blood glucose
Must not have
Have any other chronic liver disease
Have had liver transplantation or plan to have liver transplantation during the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial is testing a medication called miricorilant to see if it can help adults with a liver disease called NASH. The medication aims to reduce fat and inflammation in the liver. About 150 patients will take either miricorilant or another treatment for several months.
Who is the study for?
Adults with Nonalcoholic Steatohepatitis (NASH) can join this trial. They must have a liver fat level of ≥8% on MRI, a recent NASH diagnosis by biopsy or scans, and certain metabolic risks like type 2 diabetes or obesity. People who've had other treatments for NASH in the last year, are pregnant, have cirrhosis or significant alcohol intake can't participate.
What is being tested?
The MONARCH trial is testing Miricorilant against a placebo to see if it's effective and safe for treating NASH. Participants will be randomly assigned to either the drug or placebo group without knowing which one they're getting (double-blind).
What are the potential side effects?
While specific side effects of Miricorilant aren't listed here, common medication-related issues may include gastrointestinal discomfort, potential liver enzyme changes, fatigue, and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver condition was confirmed as NASH with specific scores on a biopsy.
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My fasting blood sugar is high or I am being treated for high blood sugar.
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My blood pressure is high or I am being treated for high blood pressure.
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My triglyceride levels are high or I am on medication for it.
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My HDL cholesterol is low or I am on medication for low HDL.
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I have been diagnosed with type 2 diabetes.
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I have at least three symptoms of metabolic syndrome.
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I have been diagnosed with NASH based on blood tests and scans.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a long-term liver condition.
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I have had or plan to have a liver transplant during the study.
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I had weight-loss surgery within the last 2 years or plan to during the study.
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I have a history of or current cirrhosis diagnosed by a doctor.
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My liver is not working properly.
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I have type 1 diabetes or my type 2 diabetes is not well-controlled.
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My BMI is either below 18 or above 45.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental (Cohort B)Experimental Treatment1 Intervention
Patients who meet the entry criteria for study CORT118335-862 (Cohort B) will be enrolled to receive 100 mg of miricorilant, twice a week for 6 weeks. Dose will be escalated to 200 mg of miricorilant, twice a week for 18 weeks.
Group II: Experimental (Cohort A)Experimental Treatment1 Intervention
Patients who meet the entry criteria for study CORT118335-862 (Cohort A) will be enrolled to receive 100 mg of miricorilant, twice a week for 48 weeks.
Group III: Placebo (Cohort A)Placebo Group1 Intervention
Patients who meet the entry criteria for study CORT118335-862 (Cohort A) will be enrolled to receive a matching placebo twice a week for 48 weeks.
Group IV: Placebo (Cohort B)Placebo Group1 Intervention
Patients who meet the entry criteria for study CORT118335-862 (Cohort B) will be enrolled to receive a matching placebo twice a week for 24 weeks.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) include lifestyle modifications, vitamin E, pioglitazone, and Selective Glucocorticoid Receptor Modulators (SGRMs) like Miricorilant. Lifestyle changes, such as diet and exercise, help reduce liver fat and improve overall liver function.
Vitamin E, an antioxidant, helps reduce oxidative stress and inflammation in the liver. Pioglitazone, a thiazolidinedione, improves insulin sensitivity and reduces liver fat.
SGRMs like Miricorilant work by modulating the glucocorticoid receptor, which can help reduce liver inflammation and fibrosis. These treatments are crucial for NAFLD patients as they target different aspects of the disease, helping to reduce liver fat, inflammation, and the risk of progression to more severe liver conditions.
Unanticipated increases in hepatic steatosis among human immunodeficiency virus patients receiving mineralocorticoid receptor antagonist eplerenone for non-alcoholic fatty liver disease.
Unanticipated increases in hepatic steatosis among human immunodeficiency virus patients receiving mineralocorticoid receptor antagonist eplerenone for non-alcoholic fatty liver disease.
Find a Location
Who is running the clinical trial?
Corcept TherapeuticsLead Sponsor
69 Previous Clinical Trials
6,288 Total Patients Enrolled
5 Trials studying Non-alcoholic Fatty Liver Disease
166 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Kavita Juneja, MDStudy DirectorCorcept Therapeutics
4 Previous Clinical Trials
313 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
92 Patients Enrolled for Non-alcoholic Fatty Liver Disease
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