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Evaluating Miricorilant for Nonalcoholic Steatohepatitis in Adults

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)

Phase 2 Interventional Corcept Therapeutics · NCT06108219

This study is testing a new medication called Miricorilant to see if it can improve liver health in adults with Nonalcoholic Steatohepatitis (NASH) or Metabolic Dysfunction-associated Steatohepatitis (MASH).

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment195 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorCorcept Therapeutics Industry-sponsored
Locations45 sites (Chandler, Arizona and 44 other locations)
Trial IDNCT06108219 on ClinicalTrials.gov

What this trial studies

This Phase 2b clinical trial evaluates the efficacy and safety of Miricorilant in adult patients diagnosed with Nonalcoholic Steatohepatitis (NASH) or Metabolic Dysfunction-associated Steatohepatitis (MASH). Approximately 120 participants will be randomized to receive either Miricorilant or a placebo twice weekly for 48 weeks, while another cohort of about 75 patients will undergo a dose escalation regimen over 24 weeks. The study aims to assess the impact of the treatment on liver health and metabolic function through rigorous histological assessments and clinical evaluations.

Who should consider this trial

Good fit: Ideal candidates include adults with a confirmed histological diagnosis of NASH or MASH and specific fibrosis scores.

Not a fit: Patients without a histological diagnosis of NASH or MASH or those with less severe liver conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve liver health and metabolic function in patients suffering from NASH and MASH.

How similar studies have performed: Other studies have shown promise in treating NASH with similar pharmacological approaches, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Cohort A: Histological diagnosis of NASH/MASH 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.
* Cohort B: Have a liver biopsy result that does not meet with the criteria for inclusion in Cohort A and is consistent with one of the following based on the consensus method of histological assessment:

  * NAS ≥ 3 with ≥1 point in each subcomponent of steatosis, inflammation, and ballooning, and a NASH-CRN fibrosis score of F1 or
  * NAS ≥ 2 with ≥1 point in subcomponent of steatosis and ≥ 1 point in subcomponent of ballooning or inflammation and a NASH-CRN fibrosis score of F2 or 3
* AST \> 17 U/L for women and AST \> 20 U/L for men.
* FibroScan® liver stiffness measurement ≥ 8 kPa and CAP ≥ 280 dB/m.
* MRI-PDFF with ≥ 8% steatosis
* Presence of at least 1 of the following metabolic syndromes that increase the risk of NASH/MASH:

  1. Diagnosis of type 2 diabetes OR
  2. Presence of 2 or more components of metabolic syndrome:

  i. Fasting blood glucose ≥ 100 mg/dL (5.6 mmol/L) or treatment for elevated blood glucose ii. Systolic blood pressure ≥ 130mmHg, diastolic blood pressure ≥ 85mmHg, or treatment for hypertension iii. Serum triglycerides ≥ 150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides iv. Serum high-density lipoprotein (HDL) cholesterol \< 40 mg/dL (1 mmol/L) in men and \< 50 mg/dL (1.3 mmol/L) in women or drug treatment for low HDL v. Overweight or obese (body mass index \[BMI\] ≥ 25 kg/m2 \[BMI ≥ 23 kg/m2 in Asians\]), or increased waist circumference ≥ 102 cm (40 in) in men and ≥ 88 cm (35 in) in women (male ≥ 90 cm \[35.4 in\]; women ≥ 80 cm \[31.5 in\] in
* Other inclusion criteria may apply

Exclusion Criteria:

* Have participated in another clinical trial within the last 3 months of Screening where the patient received active treatment for NASH/MASH.
* Have participated in a clinical trial for any other indication within the last 3 months or 5 half-lives of the treatment, whichever is longer.
* Are pregnant or lactating women
* Have a BMI \< 18 kg/m2 or \> 45 kg/m2.• Have had liver transplantation or plan to have liver transplantation during the study
* Have type 1 diabetes or poorly controlled type 2 diabetes.
* Are pregnant or lactating women
* Have a BMI \< 18 kg/m2 or \> 45 kg/m2
* Have had successful weight-loss surgery within 2 years prior to Screening or are planning weight-loss surgery during the study.
* Have a \>5% weight change within 3 months prior to Screening.
* Have significant alcohol consumption of more than 20 g per day for women and 30 g per day for men within 1 year prior to screening or score of ≥8 on AUDIT questionnaire
* Have any other chronic liver disease
* History of cirrhosis or evidence of cirrhosis by clinical, imaging, or liver biopsy evaluation
* Have hepatic decompensation
* Other exclusion criteria may apply

Where this trial is running

Chandler, Arizona and 44 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Nonalcoholic SteatohepatitisMetabolic Dysfunction-associated SteatohepatitisNonalcoholic Fatty Liver DiseaseMetabolic dysfunction-Associated SteatohepatitisMetabolic dysfunction-Associated Steatosis Liver Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.