Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2026-02-20 @ 4:31 PM
Study NCT ID:
NCT06947304
Status:
RECRUITING
Last Update Posted:
2025-10-16
First Post:
2025-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Miricorilant on Liver Fat in Patients With MASLD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-14', 'studyFirstSubmitDate': '2025-04-21', 'studyFirstSubmitQcDate': '2025-04-21', 'lastUpdatePostDateStruct': {'date': '2025-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in fasting hepatic lipogenesis after 4 weeks of treatment', 'timeFrame': 'Baseline to Week 4'}, {'measure': 'Change in peak lipogenesis after 4 weeks of treatment.', 'timeFrame': 'Baseline to Week 4'}], 'secondaryOutcomes': [{'measure': 'Change in liver fat content by MRI-PDFF after 4 weeks of treatment', 'timeFrame': 'Baseline to week 4'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nonalcoholic Fatty Liver Disease (NAFLD)', 'Nonalcoholic Steatohepatitis (NASH)', 'Metabolic dysfunction-Associated Steatohepatitis (MASH)', 'Metabolic dysfunction-Associated Steatosis Liver Disease (MASLD)'], 'conditions': ['Nonalcoholic Steatohepatitis (NASH)', 'Metabolic Dysfunction-Associated Steatohepatitis (MASH)', 'Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)', 'Non-alcoholic Fatty Liver Disease (NAFLD)']}, 'descriptionModule': {'briefSummary': 'A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients with Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)', 'detailedDescription': 'Approximately 8 patients who are eligible for participation in the study will be assigned to a single dose cohort receiving 100 mg of miricorilant daily. The total duration of participation for each patient is expected to be up to 14 weeks, comprising a 6-week screening period, a 4-week treatment phase, and a 4-week follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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:\n\n 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\n 2. NAS ≥ 3 (with at least 1 point in each subcomponent of steatosis, inflammation, and ballooning) and NASH CRN fibrosis score of F1 OR\n 3. NAS ≥ 2 (with at least 1 point in subcomponent of ballooning or inflammation) and a NASH CRN fibrosis score of F2-3\n* MRI-PDFF with ≥ 8% steatosis; this assessment must be performed within 4 weeks of the Baseline Visit.\n* Presence of at least 1 of the following metabolic syndrome characteristics that increase the risk of MASH:\n\n 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\n * 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).\n\nOther inclusion criteria may apply\n\nExclusion Criteria:\n\n* Participation in another clinical trial for MASH or weight loss (e.g., GLP-1 receptor agonists) within the last 3 months.\n* Participation in any other clinical trial within the last 3 months or 5 half-lives of the treatment, whichever is longer.\n* Women who are pregnant, planning to become pregnant, or lactating.\n* BMI \\< 18 kg/m² or \\> 45 kg/m².\n* Significant alcohol consumption exceeding 20 g/day for women or 30 g/day for men within 1 year prior to screening.\n* Positive urine drug screen for amphetamines, cocaine, opiates, or cannabinoids.\n* Known or suspected cirrhosis or signs of hepatic decompensation.\n* Other chronic liver diseases such as hepatitis B or C, autoimmune hepatitis, primary biliary cholangitis, or Wilson's disease.\n* History of myocardial infarction, unstable angina, or stroke within 3 months prior to screening.\n* Uncontrolled hypertension (systolic \\> 160 mm Hg or diastolic \\> 100 mm Hg).\n* Current use of medications prohibited due to potential drug-drug interactions with study treatment.\n* Contraindications to magnetic resonance imaging (MRI).\n\nOther exclusion criteria may apply"}, 'identificationModule': {'nctId': 'NCT06947304', 'briefTitle': 'Evaluation of Miricorilant on Liver Fat in Patients With MASLD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Corcept Therapeutics'}, 'officialTitle': 'A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)', 'orgStudyIdInfo': {'id': 'CORT118335-858'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Miricorilant- 100 mg', 'description': 'Patients who meet the entry criteria for study CORT118335-858 will be enrolled to receive 100 mg of miricorilant every day for 4 weeks.', 'interventionNames': ['Drug: Miricorilant']}], 'interventions': [{'name': 'Miricorilant', 'type': 'DRUG', 'description': '100 mg administered orally, once daily', 'armGroupLabels': ['Miricorilant- 100 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65211', 'city': 'Columbia', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elizabeth Parks, PhD', 'role': 'CONTACT', 'email': 'parksej@missouri.edu', 'phone': '(573) 882-5864'}, {'name': 'Jessica George, BS', 'role': 'CONTACT', 'email': 'jgmft7@mail.missouri.edu', 'phone': '(573) 884-2014'}], 'facility': 'University of Missouri', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'centralContacts': [{'name': 'Elizabeth Parks, PhD', 'role': 'CONTACT', 'email': 'parksej@missouri.edu', 'phone': '(573) 882-5864'}], 'overallOfficials': [{'name': 'Kavita Juneja, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Corcept Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corcept Therapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Missouri-Columbia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}