Miricorilant for Liver Impairment

Recruiting at 2 trial locations

Overseen By Corcept Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Corcept Therapeutics

Must not be taking: Glucocorticoids

Disqualifiers: Uncontrolled diabetes, Alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

19 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how the drug miricorilant behaves in people with normal livers and those with moderate liver issues, including some with NASH. It aims to see if liver problems affect how the drug is processed in the body.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it does exclude participants using certain medications, like glucocorticoids, before the study. It's best to discuss your specific medications with the trial coordinators.

What makes the drug Miricorilant unique for treating liver impairment?

Miricorilant is unique because it is being explored specifically for liver impairment, and there are no standard treatments for this condition. While other drugs like Cenicriviroc target liver fibrosis through different mechanisms, Miricorilant's specific action and potential benefits for liver impairment are still under investigation. ^{1 2 3 4 5}

Who Is on the Research Team?

Joseph Custodio, PhD

Principal Investigator

Corcept Therapeutics

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I do not have a significant history of major health issues.

My liver function is impaired but stable.

I have had stable, mild or moderate liver problems for 6 months or more.

Exclusion Criteria

I have chronic kidney disease and liver problems.

My liver condition has been stable for the last 30 days.

I have had acute viral hepatitis in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

1 day

Interim PK Analysis

Interim pharmacokinetic analysis to evaluate the effect of moderate hepatic impairment

2-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Miricorilant

Trial Overview 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.

How Is the Trial Designed?

Group I: No Hepatic Impairment Experimental Treatment 1 Intervention

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

Group II: Moderate Hepatic Impairment Experimental Treatment 1 Intervention

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

Group III: Mild Hepatic Impairment Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Corcept Therapeutics

Lead Sponsor

Trials

72

Recruited

7,700+

Dr. Joseph K. Belanoff

Corcept Therapeutics

Chief Executive Officer since 2014

MD from Stanford University

Dr. William Guyer

Corcept Therapeutics

Chief Medical Officer since 2021

PharmD

Published Research Related to This Trial

Cenicriviroc (CVC) has shown promising results in improving liver fibrosis in patients with nonalcoholic steatohepatitis (NASH) during a phase 2b clinical trial involving 289 participants, demonstrating its potential as a treatment option.

CVC has a strong safety profile and effectively inhibits macrophage accumulation in the liver, which is crucial for preventing the progression of NASH to fibrosis, supporting its further development in a phase 3 trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cenicriviroc for the treatment of non-alcoholic steatohepatitis and liver fibrosis. Tacke, F.[2020]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Antifibrotic Effects of the Dual CCR2/CCR5 Antagonist Cenicriviroc in Animal Models of Liver and Kidney Fibrosis. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Cenicriviroc Treatment for Adults With Nonalcoholic Steatohepatitis and Fibrosis: Final Analysis of the Phase 2b CENTAUR Study. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Maraviroc Prevents HCC Development by Suppressing Macrophages and the Liver Progenitor Cell Response in a Murine Chronic Liver Disease Model. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Umbelliferone Ameliorates CCl4-Induced Liver Fibrosis in Rats by Upregulating PPARγ and Attenuating Oxidative Stress, Inflammation, and TGF-β1/Smad3 Signaling. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Cenicriviroc for the treatment of non-alcoholic steatohepatitis and liver fibrosis. [2020]