Miricorilant for Non-Alcoholic Steatohepatitis

Not currently recruiting at 80 trial locations

Overseen By Clinical Trial Lead Swayam Kaur

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Corcept Therapeutics

Disqualifiers: Type 1 diabetes, Cirrhosis, Alcohol use, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safety and effectiveness of miricorilant (CORT118335) for treating non-alcoholic steatohepatitis (NASH), a liver condition characterized by excess fat buildup and inflammation. Participants will be randomly assigned to receive either the medication or a placebo (a substance with no active drug) to compare outcomes. Individuals diagnosed with NASH through a liver biopsy and experiencing symptoms like high blood sugar or being overweight might be suitable candidates. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that miricorilant has been tested for safety in humans, and these studies found the treatment to be generally well-tolerated. One study tested miricorilant's effect on liver fat in patients with nonalcoholic steatohepatitis (NASH), and results showed that patients handled the treatment well without serious side effects.

Another study examined miricorilant's safety and found that while some patients experienced mild side effects, they were not severe. This suggests that miricorilant is relatively safe for humans, though more research is needed to understand all potential risks. Participating in any clinical trial involves some risk, but previous studies provide promising safety data for miricorilant. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for nonalcoholic steatohepatitis?

Most treatments for Non-Alcoholic Steatohepatitis (NASH) focus on lifestyle changes, like diet and exercise, or medications targeting insulin resistance and liver inflammation. But miricorilant works differently, targeting the hormonal pathways linked to stress and fat accumulation in the liver. Researchers are excited about miricorilant because it uses a unique active ingredient that may help reduce liver fat more effectively than current options. This new approach could offer a promising alternative for patients who haven't seen results with standard treatments.

What evidence suggests that miricorilant might be an effective treatment for non-alcoholic steatohepatitis?

Research has shown that miricorilant can greatly reduce liver fat. In previous studies, patients experienced quick and significant drops in liver fat, which is important for treating Non-Alcoholic Steatohepatitis (NASH). Miricorilant blocks certain receptors linked to stress hormones, which can affect liver health. Early results also indicate improvements in factors related to heart disease and diabetes risk. This trial will evaluate miricorilant as a promising new treatment for NASH, with participants in different arms receiving varying dosages and durations of miricorilant or placebo. ^{2 4 5 6 7}

Who Is on the Research Team?

Kavita Juneja, MD

Principal Investigator

Corcept Therapeutics

Are You a Good Fit for This Trial?

Adults with Nonalcoholic Steatohepatitis (NASH) can join this trial. They must have a liver fat level of ≥8% on MRI, a recent NASH diagnosis by biopsy or scans, and certain metabolic risks like type 2 diabetes or obesity. People who've had other treatments for NASH in the last year, are pregnant, have cirrhosis or significant alcohol intake can't participate.

Inclusion Criteria

My liver condition was confirmed as NASH with specific scores on a biopsy.

My fasting blood sugar is high or I am being treated for high blood sugar.

My blood pressure is high or I am being treated for high blood pressure.

Exclusion Criteria

I have a long-term liver condition.

I was in a NASH trial and received treatment within the last year.

Have participated in another clinical trial for any other indication within the last 3 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment (Cohort A)

Participants receive 100 mg of miricorilant or placebo twice a week for 48 weeks

48 weeks

Treatment (Cohort B)

Participants receive 100 mg of miricorilant twice a week for 6 weeks, followed by a dose escalation to 200 mg or placebo for an additional 18 weeks

24 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 MONARCH trial is testing Miricorilant against a placebo to see if it's effective and safe for treating NASH. Participants will be randomly assigned to either the drug or placebo group without knowing which one they're getting (double-blind).

How Is the Trial Designed?

Group I: Experimental (Cohort B) Experimental Treatment 1 Intervention

Patients who meet the entry criteria for study CORT118335-862 (Cohort B) will be enrolled to receive 100 mg of miricorilant, twice a week for 6 weeks. Dose will be escalated to 200 mg of miricorilant, twice a week for 18 weeks.

Group II: Experimental (Cohort A) Experimental Treatment 1 Intervention

Patients who meet the entry criteria for study CORT118335-862 (Cohort A) will be enrolled to receive 100 mg of miricorilant, twice a week for 48 weeks.

Group III: Placebo (Cohort A) Placebo Group 1 Intervention

Patients who meet the entry criteria for study CORT118335-862 (Cohort A) will be enrolled to receive a matching placebo twice a week for 48 weeks.

Group IV: Placebo (Cohort B) Placebo Group 1 Intervention

Patients who meet the entry criteria for study CORT118335-862 (Cohort B) will be enrolled to receive a matching placebo twice a week for 24 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

Citations

1. 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 ...

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

Miricorilant, a selective GR Treatment with miricorilant resulted in large, rapid reductions in liver fat content (LFC). • One patient experienced complete radiologic.

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

NCT03823703 | Study Evaluating the Safety, Efficacy, and ... Patients who meet the criteria for Study CORT118335-860 were randomized on Day 1 to receive 900 mg miricorilant, 600 mg miricorilant, or placebo for 12 weeks.

4. delta.larvol.com delta.larvol.com/Products/?ProductId=420911c3-5dce-4d86-9506-44c48c68bdba

miricorilant (CORT118335) / Corcept Therap Corcept Initiates MONARCH - A Phase 2b Trial in Non-Alcoholic Steatohepatitis (NASH) ... miricorilant in patients with non-alcoholic steatohepatitis (NASH).

5. 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.

6. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT05117489/

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

7. 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 ...