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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called miricorilant to determine if it can reduce liver fat in individuals with metabolic dysfunction-associated steatohepatitis (MASH), a type of fatty liver disease. The goal is to assess whether taking miricorilant daily for 4 weeks can improve liver health. Suitable candidates for this trial include those with fatty liver disease who have type 2 diabetes managed by diet or metformin, or those with other signs of metabolic syndrome, such as high blood pressure, high cholesterol, and being overweight. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

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

Research has shown that miricorilant was well tolerated in earlier studies. In one study, even at a higher dose of 600 mg, no serious side effects or major lab issues appeared. This suggests that miricorilant is generally safe for people. However, as this trial is in an early stage, more research is needed to fully understand its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Miricorilant is unique because it targets fatty liver disease with a novel approach. Unlike current treatments, which largely focus on lifestyle changes and medications to manage symptoms, miricorilant works by directly influencing cortisol activity in the body. Researchers are excited because this could potentially reduce liver fat more effectively and quickly, offering a new way to tackle the root cause of the disease rather than just its symptoms.

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

Research has shown that miricorilant might help reduce liver fat in people with fatty liver disease. One study found that a patient's fatty liver completely cleared after taking a higher dose of miricorilant for just over a month. In this trial, participants will receive 100 mg of miricorilant daily for 4 weeks. Miricorilant targets specific parts of the body and is considered a promising treatment for conditions like MASH (Metabolic Dysfunction-Associated Steatohepatitis). Other studies have found that miricorilant not only reduced liver fat but also improved heart and metabolic health indicators. These early results suggest that miricorilant could effectively manage fatty liver disease. ^{1 6 7 8 9}

Who Is on the Research Team?

Kavita Juneja, MD

Principal Investigator

Corcept Therapeutics

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06947304

Evaluation of Miricorilant on Liver Fat in Patients With MASLD Study Details | NCT06947304 | Evaluation of Miricorilant on Liver Fat in Patients With MASLD | ClinicalTrials.gov.

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

Miricorilant, a selective GR One patient experienced complete radiologic resolution of fatty liver upon treatment with miricorilant 600 mg for 34 days. • The LFC reductions were accompanied ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03823703

NCT03823703 | Study Evaluating the Safety, Efficacy, and ... This is a randomized, double-blind, placebo-controlled study that assessed the safety efficacy and pharmacokinetics (PK) of miricorilant in patients with ...

4. 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.

5. withpower.com withpower.com/trial/phase-1-metabolic-dysfunction-associated-steatotic-liver-disease-masld-5-2025-242d2

Miricorilant for Fatty Liver Disease Cenicriviroc (CVC) has shown promising results in improving liver fibrosis in patients with nonalcoholic steatohepatitis (NASH) during a phase 2b clinical trial ...

6. corcept.com corcept.com/wp-content/uploads/EASL2025-1.pdf

Effect of Hepatic Impairment on the Pharmacokinetics of ... SD, standard deviation. Safety. ▫ Miricorilant 600 mg was well tolerated. ▫ No grade ≥3 treatment-emergent AEs or laboratory abnormalities ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06108219

A Phase 2b, Study Evaluating Miricorilant in Adult Patients ... A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Miricorilant in Adult Patients with Nonalcoholic ...

8. hra.nhs.uk hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/safety-tolerability-and-pharmacokinetics-of-miricorilant-qsc203474/

Safety, Tolerability and Pharmacokinetics of Miricorilant ... The Sponsor is developing the test medicine, miricorilant, for the potential treatment of non-alcoholic steatohepatitis (NASH) and antipsychotic-induced weight ...

9. trialx.com trialx.com/clinical-trials/listings/249428/study-to-evaluate-the-effects-of-hepatic-impairment-on-the-pharmacokinetics-of-miricorilant/

Study to Evaluate the Effects of Hepatic Impairment ... The primary objective of this study is to determine the effect of hepatic impairment on the pharmacokinetics (PK) of miricorilant following a single oral dose ...