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

Eligibility 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 3 or more components of metabolic syndrome:
• * Other inclusion criteria may apply
• * 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