A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)

Launched by CORCEPT THERAPEUTICS · Oct 27, 2023

Keywords

ClinConnect Summary

The MONARCH trial is a research study looking at a new treatment called Miricorilant for adults with Nonalcoholic Steatohepatitis (NASH) or Metabolic Dysfunction-Associated Steatohepatitis (MASH). These conditions involve fat buildup in the liver, which can lead to serious health problems. The study is currently recruiting participants aged 18 to 75 who have specific liver biopsy results indicating NASH or MASH. To be eligible, participants should also have certain health issues related to metabolism, such as type 2 diabetes or high blood pressure.

Participants in this study will receive either Miricorilant or a placebo (a treatment that looks like Miricorilant but has no active ingredients) for a set period. Throughout the trial, their health will be closely monitored to assess the safety and effectiveness of the treatment. It's important to note that there are specific criteria that might exclude individuals from participating, such as recent participation in other clinical trials, certain liver conditions, or significant weight changes. This trial is a step toward finding better treatments for NASH and MASH, and if you think you might qualify, it could be a valuable opportunity to contribute to medical research.

Gender

ALL

Eligibility 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