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Corticosteroid

Miricorilant for Non-Alcoholic Steatohepatitis

Phase 2
Recruiting
Research Sponsored by Corcept Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histological diagnosis of NASH with NAS ≥ 4 (≥ 1 point in each subcomponent of steatosis, inflammation, and ballooning) and NASH-CRN fibrosis score of 2 or 3 based on the consensus method of histological assessment. A historical liver biopsy within 6 months of Screening with reading confirmed during the Screening period by a consensus panel is acceptable.
i. Fasting blood glucose ≥ 100 mg/dL (5.6 mmol/L) or treatment for elevated blood glucose
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6, 24, week 48
Awards & highlights

Study Summary

This trial tests a drug to treat nonalcoholic steatohepatitis (NASH) in adults to see if it's safe & effective.

Who is the study for?
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.Check my eligibility
What is being tested?
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).See study design
What are the potential side effects?
While specific side effects of Miricorilant aren't listed here, common medication-related issues may include gastrointestinal discomfort, potential liver enzyme changes, fatigue, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver condition was confirmed as NASH with specific scores on a biopsy.
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My fasting blood sugar is high or I am being treated for high blood sugar.
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My blood pressure is high or I am being treated for high blood pressure.
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My triglyceride levels are high or I am on medication for it.
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My HDL cholesterol is low or I am on medication for low HDL.
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I have been diagnosed with type 2 diabetes.
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I have at least three symptoms of metabolic syndrome.
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I have been diagnosed with NASH based on blood tests and scans.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6, 24, week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6, 24, week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent relative change from Baseline in liver-fat content assessed by MRI-PDFF.
Secondary outcome measures
Absolute change from Baseline in liver-fat content by MRI-PDFF.
Change in Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT)
Change in ELF, Pro-C3 and other markers of liver fibrosis
+10 more

Side effects data

From 2022 Phase 2 trial • 50 Patients • NCT04466215
12%
Fatigue
12%
Headache
8%
Abdominal distension
8%
Feeling less euphoric
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
CORT118335

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExperimentalExperimental Treatment1 Intervention
Patients who meet the entry criteria for study CORT118335-862 will be enrolled to receive 100 mg of miricorilant, twice a week for 48 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Patients who meet the entry criteria for study CORT118335-862 will be enrolled to receive a matching placebo twice a week for 48 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Miricorilant
2021
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

Corcept TherapeuticsLead Sponsor
68 Previous Clinical Trials
6,230 Total Patients Enrolled
5 Trials studying Non-alcoholic Fatty Liver Disease
166 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Kavita Juneja, MDStudy DirectorCorcept Therapeutics
4 Previous Clinical Trials
314 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
92 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is geriatric participation accepted in this research endeavor?

"The minimum age requirement for this research is 18 and participants must not be older than 75."

Answered by AI

Is there an eligibility criteria for enrolment in this research?

"This research is reaching out to around 150 individuals who possess non-alcoholic fatty liver disease and are aged 18 to 75. If these criteria are met, then an individual may be eligible for the trial."

Answered by AI

Has the FDA endorsed this experimental treatment?

"The safety of Experimental is assessed at a 2, as thus far there has only been limited validation on its efficacy and some evidence for its security."

Answered by AI

Are currently enrolling new participants in this experiment?

"Indeed, the information on clinicaltrials.gov verifies that this medical trial is open to applicants at present. This research was first posted on October 25th 2023 and has been most recently updated as of November 1st 2023. 150 individuals are needed from one site for enrollment in the study."

Answered by AI

What is the aggregate number of individuals enrolled in this clinical investigation?

"Affirmative. Per information available on clinicaltrials.gov, this scientific research that was originally posted on October 25th 2023 is still recruiting participants. The trial aims to involve 150 patients from 1 medical facility in the study."

Answered by AI

Who else is applying?

What site did they apply to?
Site #431
Site #373
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)
2023. "A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06108219.
All > Fatty Liver > Tucson
~100 spots leftby Dec 2025
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