Miricorilant for Liver Impairment

Recruiting at2 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Corcept Therapeutics

No Placebo Group

Trial Summary

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.

Research Team

Joseph Custodio, PhD

Principal Investigator

Corcept Therapeutics

Eligibility Criteria

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.

Treatment Details

Interventions

• Miricorilant (Corticosteroid)

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.

Participant Groups

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