What side effects are associated with this type of intervention?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) include lifestyle modifications, medications like pioglitazone, vitamin E, and newer agents such as Selective Glucocorticoid Receptor Modulators (SGRMs) like Miricorilant. Known side effects of these treatments can vary. For example, pioglitazone may cause weight gain, edema, and an increased risk of bone fractures. Vitamin E at high doses has been associated with an increased risk of hemorrhagic stroke and prostate cancer. Miricorilant, being an SGRM, is still under investigation, but similar agents may cause side effects such as gastrointestinal disturbances, dizziness, and headache. It is important to discuss these potential side effects with a healthcare provider to tailor the treatment to individual patient needs.

What prior FDA approvals exist?

As of now, there are no FDA-approved medications specifically for the treatment of Non-alcoholic Fatty Liver Disease (NAFLD). Treatments under investigation, such as Miricorilant, a Selective Glucocorticoid Receptor Modulator (SGRM), are part of ongoing clinical trials aimed at addressing this condition. Other investigational drugs for NAFLD include those targeting metabolic pathways, inflammation, and fibrosis, but none have yet received FDA approval.

What other types of research exist?

Promising novel alternatives to Miricorilant for NAFLD patients include: 1) MET409, a structurally optimized FXR agonist; 2) Cilofexor, a nonsteroidal FXR agonist; 3) TERN-101, a liver-distributed FXR agonist; 4) Resmetirom, a selective thyroid hormone receptor-β agonist; and 5) BRL37344, a β3 adrenergic receptor agonist. These treatments have shown efficacy in reducing liver fat and improving liver function in clinical trials.

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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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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.

0 / 15Eligibility criteria met

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.