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

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Corcept Therapeutics

Criteria

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