[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635513":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":35,"responsibleParty":50,"collaborators":20,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":20,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":57,"conditions":68,"keywords":73,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Corcept Therapeutics","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Miricorilant 60mg","EXPERIMENTAL","Patients who meet the entry criteria for study CORT118335-863 will be administered a single dose of 60 mg miricorilant.",[13],"Drug: Miricorilant",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Miricorilant","Single dose of 60 mg miricorilant",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Aprille Espinueva, PharmD","STUDY_DIRECTOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Eric Lawitz, MD","CONTACT","210-253-3426","lawitz@txliver.com",{"name":32,"role":28,"phone":29,"phoneExt":33,"email":34},"Toluwalase Okubote, MBBS, MPH, PMP","7003","tokubote@txliver.com",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":20},"Site# 433","RECRUITING","San Antonio","Texas","78215","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-98.49363,29.42412,{"lat":48,"lon":47},{"type":51,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100635513","phase-1-evaluating-the-pharmacokinetics-and-safety-of-miricorilant-100635513",false,"NCT07553663","Evaluating the Pharmacokinetics and Safety of Miricorilant","A Phase 1b, Open-Label Study Evaluating the Pharmacokinetics and Safety of Miricorilant in Adult Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Inclusion Criteria:\n\n* Evidence of presumed MASH with either FibroScan liver stiffness measurement ≥ 8 kPa and controlled attenuation parameter (CAP) ≥ 280 dB\u002Fm OR historical biopsy within 12 months of screening that meets the following criteria:\n\n  1. Nonalcoholic fatty liver disease (NAFLD) activity score (NAS) ≥ 3 with at least ≥ 1 point in any two subcomponents of steatosis, inflammation, and ballooning, and a Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) fibrosis score of F1 OR\n  2. NAS ≥ 2 with at least ≥ 1 point in any two subcomponents of steatosis, inflammation, and ballooning, and a NASH CRN fibrosis score of F2 or 3.\n* Aspartate aminotransferase (AST) \\> 17 U\u002FL for women and AST \\> 20 U\u002FL for men. The AST inclusion criterion does not apply to participants with an eligible historical liver biopsy performed within 12 months of Screening.\n* Presence of at least 1 of the following metabolic conditions that increase the risk of MASH:\n\n  1. Diagnosis of type 2 diabetes OR\n  2. Presence of 2 or more components of metabolic syndrome:\n\n     * Fasting blood glucose ≥ 100 mg\u002FdL (5.6 mmol\u002FL) or treatment for elevated blood glucose\n     * Systolic blood pressure ≥ 130 mm Hg, diastolic blood pressure ≥ 85 mm Hg, or treatment for hypertension\n     * Serum triglycerides ≥ 150 mg\u002FdL (1.7 mmol\u002FL) or drug treatment for elevated triglycerides\n     * Serum high-density lipoprotein (HDL) cholesterol \\\u003C 40 mg\u002FdL (1 mmol\u002FL) in men and \\\u003C 50 mg\u002FdL (1.3 mmol\u002FL) in women or drug treatment for low HDL\n     * Overweight or obese (body mass index \\[BMI\\] ≥ 25 kg\u002Fm2 \\[BMI ≥ 23 kg\u002Fm2 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\nExclusion Criteria:\n\n* Women who are pregnant, planning to become pregnant, or are lactating.\n* Have a BMI \\\u003C 18 kg\u002Fm2 or \\> 45 kg\u002Fm2.\n* 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\n* Have had liver transplantation or plan to have liver transplantation during the study.\n* Have type 1 diabetes.\n* Have poorly controlled type 2 diabetes with a glycated hemoglobin (HbA1c)\n\n  * 9.5%.\n* Have any other chronic liver disease\n* History of cirrhosis or evidence of cirrhosis by clinical, imaging, or liver biopsy evaluation\n* Have hepatic decompensation\n\nOther exclusion criteria may apply","ALL","18 Years","75 Years",{"count":63,"type":64},15,"ESTIMATED","INTERVENTIONAL",[67],"PHASE1",[69,70,71,72],"Nonalcoholic Steatohepatitis (NASH)","Metabolic Dysfunction-Associated Steatohepatitis (MASH) \u002F Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis","Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)","Non-alcoholic Fatty Liver Disease (NAFLD)",[74,69,75,76],"Nonalcoholic Fatty Liver Disease (NAFLD)","Metabolic dysfunction-Associated Steatohepatitis (MASH)","Metabolic dysfunction-Associated Steatosis Liver Disease (MASLD)","2026-05-21",{"date":79,"type":80},"2026-05-26","ACTUAL",{"date":82,"type":80},"2026-04-30",{"date":84,"type":64},"2026-10-30",{"name":5,"class":6},1]