NCT06947304 Evaluation of Miricorilant on Liver Fat in Patients With MASLD
| NCT ID | NCT06947304 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Corcept Therapeutics |
| Condition | Nonalcoholic Steatohepatitis (NASH) |
| Study Type | INTERVENTIONAL |
| Enrollment | 8 participants |
| Start Date | 2025-08-22 |
| Primary Completion | 2026-05 |
Trial Parameters
Eligibility Fast-Check
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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