Miricorilant for Liver Impairment

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the liver's condition affects the body's processing of miricorilant, a new treatment. It targets individuals with mild to moderate liver impairment and compares them to those with healthy livers. Participants will take a single dose of the medication to observe liver processing. Individuals with stable liver issues for at least six months, such as nonalcoholic steatohepatitis (NASH) or metabolic syndrome, may qualify for the trial. As a Phase 1 trial, this research aims to understand the treatment's effects in people, offering participants the chance to be among the first to receive it.

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.

Is there any evidence suggesting that miricorilant is likely to be safe for humans?

Research has shown that miricorilant has been studied for its safety in people with liver conditions like nonalcoholic steatohepatitis (NASH). In one study, patients took miricorilant to assess its ability to reduce liver fat, and it was generally well-tolerated. Some participants experienced side effects, but these were mostly mild.

Another study tested miricorilant in a controlled setting and confirmed its safety. While some side effects occurred, they were not serious and could be managed. These studies focused on patients with liver issues, which is relevant for this trial.

Overall, miricorilant has undergone testing, and results suggest it is safe for people, especially those with liver concerns. This provides reassurance about its safety for anyone considering joining this trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for liver impairment?

Unlike the standard treatments for liver impairment, which often include lifestyle changes and medications like ursodeoxycholic acid or corticosteroids, miricorilant presents a fresh approach. Miricorilant is notable for its unique mechanism of action, targeting glucocorticoid receptors, potentially reducing liver fat and inflammation more effectively. Researchers are excited about this treatment because it promises to address the root causes of liver impairment, offering hope for improved outcomes with a simple oral dosage. This targeted approach might offer quicker relief and better long-term management of liver conditions compared to existing therapies.

What evidence suggests that miricorilant might be an effective treatment for liver impairment?

Research has shown that miricorilant, a medication targeting cortisol, may help treat liver problems such as nonalcoholic steatohepatitis (NASH). Studies have found that it can reduce liver fat and improve liver health. For example, one study showed that miricorilant significantly improved key indicators of liver health. In this trial, participants with varying degrees of hepatic impairment, as well as those without impairment, will receive miricorilant to further evaluate its potential as a new treatment for liver issues. ^{3 6 7 8 9}

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.

Inability to be venipunctured and/or tolerate catheter venous access

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. clinicaltrials.gov clinicaltrials.gov/study/NCT03823703

NCT03823703 | Study Evaluating the Safety, Efficacy, and ... This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and efficacy of miricorilant (CORT118335) in patients with presumed ...

2. ir.corcept.com ir.corcept.com/news-releases/news-release-details/corcepts-miricorilant-shows-great-promise-treatment-non

Corcept's Miricorilant Shows Great Promise in Treatment of ... Phase 1b study demonstrates that miricorilant, a selective cortisol modulator, effectively reduces liver fat, improves liver health and key ...

3. researchgate.net researchgate.net/profile/Rafael-Mayoral-Monibas/publication/377466522_Miricorilant_Reduced_Liver_Fat_and_Cardiometabolic_Disease_Markers_in_a_Phase_1b_Open-Label_Dose-Finding_Study_in_Patients_with_Non-Alcoholic_Steatohepatitis_NASH/links/65a8239ef323f74ff1c80bd0/Miricorilant-Reduced-Liver-Fat-and-Cardiometabolic-Disease-Markers-in-a-Phase-1b-Open-Label-Dose-Finding-Study-in-Patients-with-Non-Alcoholic-Steatohepatitis-NASH.pdf?origin=scientificContributions

Miricorilant-Reduced-Liver-Fat-and-Cardiometabolic- ... Summary & Conclusions. • Miricorilant, a nonsteroidal selective GR modulator (SGRM), may offer a promising new strategy for treating NASH/MASH.

4. withpower.com withpower.com/trial/phase-1-non-alcoholic-fatty-liver-disease-8-2022-248bb

Miricorilant for Liver Impairment · Info for Participants This trial tests how the drug miricorilant behaves in people with normal livers and those with moderate liver issues, including some with NASH.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05320146

NCT05320146 | A Sub Study of the ... This optional sub study is a part of the phase 1b, Open-Label Study is to assess the safety, efficacy of miricorilant in patients with presumed Nonalcoholic ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05117489?term=miricorilant%20&rank=3

NCT05117489 | A Study Evaluating the Safety, Efficacy, ... This phase 1b, Open-Label Study will assess the safety, efficacy and pharmacokinetics (PK) of miricorilant in patients with presumed Nonalcoholic ...

7. corcept.com corcept.com/wp-content/uploads/AASLD2021-poster-04112022-updated2.pdf

Miricorilant, a selective GR This phase 2a study assessed the safety and efficacy of miricorilant in reducing liver fat content in patients with presumed NASH. Premise. • Miricorilant's ...

8. adisinsight.springer.com adisinsight.springer.com/drugs/800050518

Miricorilant - Corcept Therapeutics - AdisInsight - Springer Miricorilant (CORT 118335) is a dual selective glucocorticoid receptor modulator and mineralocorticoid receptor antagonist, being developed by Corcept.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9542772/

The Effect of Hepatic Impairment on the Pharmacokinetics ... The effect of hepatic impairment on exposure to felcisetrag was minimal, suggesting that dose adjustment may be unnecessary in patients with hepatic impairment.