Miricorilant for Non-Alcoholic Steatohepatitis

Recruiting at 46 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

195 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

This trial is testing a medication called miricorilant to see if it can help adults with a liver disease called NASH. The medication aims to reduce fat and inflammation in the liver. About 150 patients will take either miricorilant or another treatment for several months.

Research Team

Kavita Juneja, MD

Principal Investigator

Corcept Therapeutics

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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