Miricorilant for Fatty Liver Disease

Overseen By Elizabeth Parks, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Corcept Therapeutics

Must be taking: Metformin

Must not be taking: GLP-1 agonists

Disqualifiers: Pregnancy, Cirrhosis, Alcohol use, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

8 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that current use of medications that could interact with the study treatment is prohibited. It's best to discuss your specific medications with the trial team.

How does the drug Miricorilant differ from other treatments for fatty liver disease?

There is no specific information available about Miricorilant for fatty liver disease in the provided research articles. ^{1 2 3 4 5}

What is the purpose of this trial?

A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients with Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Research Team

Kavita Juneja, MD

Principal Investigator

Corcept Therapeutics

Eligibility Criteria

This trial is for patients with presumed Metabolic Dysfunction-Associated Steatohepatitis (MASLD), a type of fatty liver disease. Specific eligibility criteria are not provided, but typically participants should have the condition being studied and meet certain health requirements.

Inclusion Criteria

My recent MRI shows I have significant liver fat.

Stable weight within the last 6 months with no more than a 5% loss of initial body weight

My liver tests show significant scarring or stiffness.

Exclusion Criteria

Positive urine drug screen for specific substances

I have a chronic liver condition like hepatitis or Wilson's disease.

I have or might have severe liver disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

6 weeks

Treatment

Participants receive 100 mg of miricorilant daily

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Miricorilant

Trial Overview The study is testing Miricorilant's effects on liver fat in MASLD patients. It's an open-label Phase 1 trial, meaning everyone knows they're getting the drug and it's at an early stage to assess safety and how well it works.

Participant Groups

Group I: Miricorilant- 100 mg Experimental Treatment 1 Intervention

Patients who meet the entry criteria for study CORT118335-858 will be enrolled to receive 100 mg of miricorilant every day for 4 weeks.

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

University of Missouri-Columbia

Collaborator

Trials

387

Recruited

629,000+

Findings from Research

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]

Obeticholic acid has shown promising results in reducing liver fibrosis in adults with nonalcoholic steatohepatitis (NASH), demonstrating a 25% reduction compared to 12% in the placebo group after 18 months of treatment in a study of 931 participants.

Current research is exploring various pharmacotherapies targeting different mechanisms in NAFLD, highlighting the importance of understanding patient subgroups for more personalized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolving Role for Pharmacotherapy in NAFLD/NASH. Attia, SL., Softic, S., Mouzaki, M.[2021]

A network meta-analysis of 26 randomized controlled trials identified that different antifibrotic drugs for nonalcoholic fatty liver disease (NAFLD) have varying risks of side effects, with lanifibranor associated with the highest risk of diarrhea and liraglutide linked to the highest risk of constipation.

Semaglutide was found to have the highest incidence of nausea and abdominal pain, while cenicriviroc was associated with increased fatigue, indicating that clinicians should consider these side effects when prescribing treatments for NAFLD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side effect profile of pharmacologic therapies for liver fibrosis in nonalcoholic fatty liver disease: a systematic review and network meta-analysis. Li, Y., Lei, R., Lei, H., et al.[2023]

In a systematic review of 10 studies involving patients with non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH), treatment with 4 mg saroglitazar significantly reduced liver enzymes, including alanine transaminase (ALT) and aspartate transaminase (AST), indicating improved liver function.

Saroglitazar also led to significant improvements in liver stiffness and metabolic parameters such as glycated hemoglobin, total cholesterol, and triglycerides, suggesting it is an effective and safe treatment option for managing NAFLD and NASH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of saroglitazar in the treatment of non-alcoholic fatty liver disease or non-alcoholic steatohepatitis: A systematic review and meta-analysis. Bandyopadhyay, S., Samajdar, SS., Das, S.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

Evolving Role for Pharmacotherapy in NAFLD/NASH. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Side effect profile of pharmacologic therapies for liver fibrosis in nonalcoholic fatty liver disease: a systematic review and network meta-analysis. [2023]

4. France pubmed.ncbi.nlm.nih.gov

Effects of saroglitazar in the treatment of non-alcoholic fatty liver disease or non-alcoholic steatohepatitis: A systematic review and meta-analysis. [2023]

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

Prolonged cenicriviroc therapy reduces hepatic fibrosis despite steatohepatitis in a diet-induced mouse model of nonalcoholic steatohepatitis. [2020]