What side effects are associated with this type of intervention?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) include glucocorticoid receptor antagonists, lipid-lowering agents, and antifibrotic drugs. Glucocorticoid receptor antagonists, such as those similar to miricorilant, can lead to side effects like weight gain, impaired glucose tolerance, and increased risk of infections. Lipid-lowering agents are generally safe but may cause muscle pain, liver enzyme abnormalities, and gastrointestinal issues. Antifibrotic drugs like nintedanib can slow disease progression but may result in diarrhea, liver enzyme elevation, and cardiovascular risks. Patients should discuss these potential side effects with their healthcare provider to make informed treatment decisions.

What prior FDA approvals exist?

As of now, there are no FDA-approved drugs specifically for the treatment of Non-alcoholic Fatty Liver Disease (NAFLD). However, several treatments are under investigation, including Glucocorticoid Receptor Antagonists like Miricorilant. These investigational drugs aim to address the underlying mechanisms of NAFLD, such as inflammation and fibrosis. Other therapeutic approaches being studied include antifibrotic agents, metabolic modulators, and anti-inflammatory drugs.

What other types of research exist?

Promising alternatives to Miricorilant for NAFLD patients include FXR agonists such as MET409, cilofexor, and TERN-101, as well as the selective thyroid hormone receptor-β agonist resmetirom. These treatments have demonstrated potential in clinical trials for reducing liver fat and improving liver health.

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Corticosteroid

Miricorilant for Liver Impairment

Phase 1

Recruiting

Research Sponsored by Corcept Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 144 hours post-dose

Awards & highlights

Study Summary

This trial will compare how well miricorilant works in people with different degrees of liver impairment.

Who is the study for?

This trial is for adults with moderate liver problems (hepatic impairment) or nonalcoholic fatty liver disease, who are not heavy smokers and have stable body weight. They must be able to swallow tablets, not have had significant alcohol use recently, and agree to contraception if applicable. People with severe liver issues, recent major illnesses or surgeries, uncontrolled diabetes or other serious health conditions cannot join.Check my eligibility

What is being tested?

The study tests how a single dose of the drug Miricorilant behaves in the body when someone has moderate liver problems compared to those with normal liver function. It's looking at whether having a fatty liver changes how the drug works after one oral dose.See study design

What are the potential side effects?

While specific side effects for Miricorilant aren't listed here, drugs like it can cause stomach upset, potential allergic reactions, changes in blood sugar levels or blood pressure. The study will monitor participants closely for any adverse effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 144 hours post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 144 hours post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 144 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AUC from Time Zero to Infinity (AUC0-∞)

Area under the Concentration-Time Curve (AUC) from Time Zero to the Last Non-Zero Concentration (AUC 0-t)

Maximum Observed Plasma Concentration (Cmax)

Secondary outcome measures

Electrocardiogram

Number of Participants with Clinically-Significant Laboratory Test Abnormality

Number of Participants with Clinically-Significant Vital Sign Abnormality

+2 more

Side effects data

From 2022 Phase 2 trial • 50 Patients • NCT04466215

12%

Fatigue

12%

Headache

Abdominal distension

Feeling less euphoric

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

CORT118335

Trial Design

3Treatment groups

Experimental Treatment

Group I: No Hepatic ImpairmentExperimental Treatment1 Intervention

Participants will receive a single oral dose of miricorilant (6 X100 mg) tablets.

Group II: Moderate Hepatic ImpairmentExperimental Treatment1 Intervention

Participants will receive a single oral dose of miricorilant (6 X100 mg) tablets.

Group III: Mild Hepatic ImpairmentExperimental Treatment1 Intervention

Participants will receive a single oral dose of miricorilant (6 X100 mg) tablets.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Miricorilant

2021

Completed Phase 2

~150

Do I qualify?Apply below to find out

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, such as diet and exercise, and pharmacological interventions. Glucocorticoid receptor antagonists, like Miricorilant, work by blocking the effects of glucocorticoids, which can reduce hepatic fat accumulation and inflammation. This is crucial for NAFLD patients as it helps to prevent the progression of liver damage. Other treatments include insulin sensitizers like pioglitazone, which improve insulin resistance, and vitamin E, which has antioxidant properties that reduce liver inflammation. These treatments are important as they target the underlying mechanisms of NAFLD, helping to manage and potentially reverse the disease.

Selective Glucocorticoid Receptor Modulation Prevents and Reverses Nonalcoholic Fatty Liver Disease in Male Mice.Unanticipated increases in hepatic steatosis among human immunodeficiency virus patients receiving mineralocorticoid receptor antagonist eplerenone for non-alcoholic fatty liver disease.