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)

CORT118335-862

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

2023-10-25

2025-12-01

2025-12-01

Recruiting

Early phase I

150

Inclusion Criteria: * 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. * AST \> 17 U/L for women and AST \> 20 U/L for men. * FibroScan® liver stiffness measurement ≥ 8 kPa and CAP ≥ 300 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 3 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 6 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

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2024-03-04