NCT06947304 Evaluation of Miricorilant on Liver Fat in Patients With MASLD

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 8 participants in total. It began in 2025-08-22 with a primary completion date of 2026-05.

Brief Summary

A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients with Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Eligibility Criteria

Inclusion Criteria: * AST \> 17 U/L for women and AST \> 20 U/L for men. The AST inclusion criterion does not apply to participants with an eligible historical liver biopsy performed within 12 months of screening showing one of the following: 1. NAFLD Activity Score (NAS) ≥ 4 (with at least 1 point in each subcomponent of steatosis, inflammation, and ballooning) and NASH Clinical Research Network (CRN) fibrosis score of F0 OR 2. NAS ≥ 3 (with at least 1 point in each subcomponent of steatosis, inflammation, and ballooning) and NASH CRN fibrosis score of F1 OR 3. NAS ≥ 2 (with at least 1 point in subcomponent of ballooning or inflammation) and a NASH CRN fibrosis score of F2-3 * MRI-PDFF with ≥ 8% steatosis; this assessment must be performed within 4 weeks of the Baseline Visit. * Presence of at least 1 of the following metabolic syndrome characteristics that increase the risk of MASH: a. Diagnosis of type 2 diabetes managed with diet alone or diet and metformin (metformin dose must be stable for at least 1 month prior to screening) OR b. 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 with metformin ii. Systolic blood pressure ≥ 130 mm Hg, diastolic blood pressure ≥ 85 mm Hg, or treatment for hypertension iii. Serum TG ≥ 150 mg/dL (1.7 mmol/L) iv. Serum high-density lipoprotein cholesterol (HDL) \< 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. Having overweight or obesity (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 (men ≥ 90 cm \[35.4 in\]; women ≥ 80 cm \[31.5 in\] in Asians). Other inclusion criteria may apply Exclusion Criteria: * Participation in another clinical trial for MASH or weight loss (e.g., GLP-1 receptor agonists) within the last 3 months. * Participation in any other clinical trial within the last 3 months or 5 half-lives of the treatment, whichever is longer. * Women who are pregnant, planning to become pregnant, or lactating. * BMI \< 18 kg/m² or \> 45 kg/m². * Significant alcohol consumption exceeding 20 g/day for women or 30 g/day for men within 1 year prior to screening. * Positive urine drug screen for amphetamines, cocaine, opiates, or cannabinoids. * Known or suspected cirrhosis or signs of hepatic decompensation. * Other chronic liver diseases such as hepatitis B or C, autoimmune hepatitis, primary biliary cholangitis, or Wilson's disease. * History of myocardial infarction, unstable angina, or stroke within 3 months prior to screening. * Uncontrolled hypertension (systolic \> 160 mm Hg or diastolic \> 100 mm Hg). * Current use of medications prohibited due to potential drug-drug interactions with study treatment. * Contraindications to magnetic resonance imaging (MRI). Other exclusion criteria may apply

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