[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Corcept Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":194},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,45,72,97,126,171],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100614190","phase-1-two-part-study-of-nenocorilant-combined-with-nivolumab-in-patients-with-advanced-solid-malignancies-100614190",false,"NCT07276373","Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies","A Phase 1b\u002F2, Open-Label, Dose-Finding and Proof of Concept Study of Nenocorilant in Combination With Anti-Programmed Cell Death\u002F(Ligand) 1 in Patients With Advanced Solid Malignancies","Inclusion Criteria:\n\nPart 1\n\n* Signed and dated institutional review board (IRB)\u002F independent ethics committee (IEC)-approved informed consent form (ICF)\n* Has solid malignancies that have received all available standard therapies for the specific tumor type or for which no standard therapy exists, unless patient is intolerant of treatment\n* Has a life expectancy of ≥ 3 months\n* Has evaluable disease based on RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Has adequate organ function\n* Negative serum or urine pregnancy test for female patients of childbearing potential\n* Agreement to use appropriate precautions to avoid pregnancy, unless the patient and\u002For their sole sexual partner is permanently sterilized\n\nExclusion Criteria:\n\nPart 1\n\n* Past or current immune-related adverse events (irAEs) due to anti-programmed cell death protein 1 ligand 1 (PD\\[L\\]1) therapy that meet any of the following criteria:\n\n  1. Grade ≥ 3\n  2. Resulted in discontinuation of anti-PD(L)1 therapy\n* Medical history of an autoimmune or inflammatory disease requiring immunosuppressive therapy\n* Medical history of adrenal insufficiency\n* Has had any major surgery within 4 weeks prior to the first dose of study treatment\n* Concurrent treatment with mifepristone or another glucocorticoid receptor (GR) modulator\n* Unable to swallow, retain, or absorb oral medication\n* Concurrent participation in another interventional clinical trial\n* Has toxicities due to prior therapies that are reversible and have not resolved\n* Requirement for treatment with prohibited medications, including but not limited to systemic corticosteroids and cytochrome P450(CYP)3A inducers or inhibitors\n* Has a known history of severe hypersensitivity to any of the study drugs, or other human\u002Fhumanized monoclonal antibodies\n* Pregnant or lactating patients or female patients expecting to conceive children within the projected duration of the trial\n* Has clinically significant uncontrolled condition(s) which, in the opinion of the Investigator, may confound the results of the trial or interfere with the patient's safety or participation\n* Known psychiatric disorder that would interfere with trial compliance\n* Has infection with HIV, hepatitis C virus, or hepatitis B virus\n* Has untreated parenchymal brain metastasis or has uncontrolled central nervous system metastases\n* Has a history of another malignancy within 2 years prior to study treatment, unless cured\n* Has received prior autologous or allogeneic organ or tissue transplantation\n* A QTcF interval \\>450 msec, a family history of long QT syndrome or unexplained sudden death at young age, or a requirement for use of medication that may prolong the QTc interval","ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This open-label, dose-finding, and proof of concept study will evaluate the safety, tolerability, maximum-tolerated dose (MTD) and\u002For optimal dose of nenocorilant when administered in combination with nivolumab in patients with advanced solid malignancies.",[27],"Neoplasms",[29,30,31],"Advanced Solid Tumors","Solid Tumors","Solid Malignancies","RECRUITING","2026-06-26",{"date":35,"type":36},"2026-06-30","ACTUAL",{"date":38,"type":36},"2026-01-16",{"date":40,"type":20},"2027-01",{"name":42,"class":43},"Corcept Therapeutics","INDUSTRY",4,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100612879","phase-2-relacorilant-with-nab-paclitaxel-and-gemcitabine-in-patients-with-metastatic-pancreatic-adenocarcinoma-100612879","NCT07259317","Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma","A Phase 2, Single-Arm Trial of Relacorilant in Combination With Nab-Paclitaxel and Gemcitabine in Chemotherapy-Naïve Patients With Metastatic Pancreatic Adenocarcinoma (TRIDENT)","Inclusion Criteria:\n\n* Signed and dated informed consent form prior to screening procedures\n* Histologic diagnosis or cytologic diagnosis of pancreatic adenocarcinoma (PDAC)\n* Initial diagnosis of metastatic disease occurred ≤9 weeks prior to enrollment in the study\n* Life expectancy of ≥3 months\n* Radiographic confirmation of metastatic disease with at least 1 distant tumor metastasis measurable on radiology imaging per RECIST version 1.1 criteria\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Able to provide informed consent and comply with protocol requirements\n* Able to swallow and retain oral medication and does not have uncontrolled emesis\n* Has adequate gastrointestinal absorption\n* Received no prior systemic anticancer chemotherapy to treat metastatic PDAC. Treatment of PDAC with a single agent RAS inhibitor is permitted.\n* If a patient received prior treatment of PDAC with chemotherapy, disease progression must have occurred \\>12 months after completing the last dose, and no persistent treatment-related toxicities can be present.\n* Adequate organ function\n* Negative pregnancy test for patients of childbearing potential\n* Agree to use protocol defined precautions to avoid pregnancy\n\nExclusion Criteria:\n\n* Any major surgery within 4 weeks prior to enrollment\n* Prior treatment as follows:\n\n  1. Radiotherapy, surgery, chemotherapy, immunotherapy, investigational therapy for the treatment of metastatic disease\n  2. Systemic, inhaled, or prescription strength topical corticosteroids within 5 times the half-life of the corticosteroid used prior to first dose of study drug\n* Received gemcitabine or nab-paclitaxel to treat their PDAC\n* Known germline or somatic breast cancer gene (BRCA) mutation\n* Peripheral neuropathy from any cause \\>Grade 1\n* Medical conditions requiring chronic or frequent treatment with corticosteroids\n* History of severe hypersensitivity or severe reaction to any of study drugs or their excipients\n* Concurrent treatment with mifepristone or other glucocorticoid receptor modulators.\n* Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient's safety or participation\n* Active infection with HIV, hepatitis C or hepatitis B virus\n* Known untreated parenchymal brain metastasis or uncontrolled central nervous system metastases\n* History of other malignancy within 3 years prior to enrollment\n* Taking protocol-prohibited medications\n* Concurrent treatment with other investigational treatment studies for cancer\n* Has received a live vaccine within 30 days prior to the study start date",{"count":53,"type":20},80,[24],"This is a 2-part, Phase 2 study to evaluate the safety, tolerability, dosing, pharmacokinetics (PK), and efficacy of relacorilant in combination with nab-paclitaxel and gemcitabine in chemotherapy-naïve patients with metastatic pancreatic adenocarcinoma (PDAC).",[57,58],"Adenocarcinoma","Carcinoma, Pancreatic Ductal",[60,57,61,62],"Pancreatic","PDAC","Pancreas","2026-06-15",{"date":65,"type":36},"2026-06-17",{"date":67,"type":36},"2026-01-27",{"date":69,"type":20},"2027-09",{"name":42,"class":43},14,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"100470550","phase-2-dazucorilant-in-patients-with-amyotrophic-lateral-sclerosis-100470550","NCT05407324","Dazucorilant in Patients With Amyotrophic Lateral Sclerosis","A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety and Efficacy of CORT113176 (Dazucorilant) in Patients With Amyotrophic Lateral Sclerosis (DAZALS)","DAZALS","Inclusion Criteria:\n\n* Male and female patients ≥18 years of age with sporadic or familial ALS. In Part 1, patients must have a risk of ALS progression characterized by a European Network for the Cure of ALS (ENCALS) risk profile score ≥ -6 and ≤ -3. In Part 2 patients must have a risk of ALS progression characterized by an Treatment Research Initiative to Cure ALS (TRICALS) risk profile score ≥ -7 and ≤ -3.\n* If taking riluzole, edaravone, and\u002For sodium phenylbutyrate and taurursodiol, must be on a stable dose prior to Screening. Sodium phenylbutyrate and taurursodiol are not permitted for patients enrolled in Part 2 of the study.\n* Part 2 only: Patients with a pathogenic mutation in superoxide dismutase 1 gene (SOD1) must not be receiving treatment with tofersen or eligible for treatment with tofersen if available. Patients who have received prior treatment with tofersen and discontinued due to safety and\u002For efficacy reasons prior to Screening are eligible.\n* Part 2 only: Use of ultra high-dose methylcobalamin for the treatment of ALS is permitted provided the patient has been on a stable dose for ≥11 weeks prior to the Day 1 visit.\n\nExclusion Criteria:\n\n* History of a clinically significant non-ALS neurologic disorder\n* Inability to swallow capsules.\n* Blood platelet count \\\u003C150,000\u002Fmm\\^3.\n* Renal impairment indicated by Estimated Glomerular Filtration Rate (eGFR) ≤30 mL\u002Fmin\u002F1.73 m\\^2. Part 2 only: Patients with a recent history of acute kidney injury should have returned to their baseline renal function (i.e, eGFR prior to acute kidney injury) prior to enrollment.\n* Human immunodeficiency virus (HIV) or current chronic\u002Factive infection with hepatitis C virus or hepatitis B virus. Part 2 only: Known history of HIV or chronic\u002Factive infection with hepatitis C or hepatitis B virus; testing does not need to be performed if infection status is unknown.\n* Women who are pregnant, planning to become pregnant, or are breastfeeding.\n* Use of non-invasive ventilation (NIV) or mechanical ventilation via tracheostomy, or on any form of oxygen supplementation.\n* Cancer that is currently being treated (except adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin, stage I endometrial cancer or carcinoma in situ of the cervix or breast) or a history of cancer with an expected survival \\\u003C 2 years.\n* Current or anticipated need of a diaphragm pacing system (DPS).\n* Previous exposure or treatment with glucocorticoid receptor modulators or antagonists.\n* Taking, or have taken, any systemic, inhaled, or potent dermatologic topical corticosteroids (Class I to III) within a period equivalent to 5 half-lives of the corticosteroid used prior to first dose of study drug. Patients who have stopped glucocorticoid use should have an alternative option if their condition deteriorates during the study.",{"count":81,"type":20},279,[24],"The purpose of this 2-part study is to assess the safety and efficacy of CORT113176 (dazucorilant) in patients with Amyotrophic Lateral Sclerosis (ALS).",[85],"Amyotrophic Lateral Sclerosis",[87],"ALS, Amyotrophic Lateral Sclerosis","2026-06-12",{"date":90,"type":36},"2026-06-16",{"date":92,"type":36},"2022-11-15",{"date":94,"type":20},"2027-11",{"name":42,"class":43},35,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":104,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":102,"conditions":108,"keywords":113,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},"100635513","phase-1-evaluating-the-pharmacokinetics-and-safety-of-miricorilant-100635513","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","75 Years",{"count":106,"type":20},15,[23],[109,110,111,112],"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)",[114,109,115,116],"Nonalcoholic Fatty Liver Disease (NAFLD)","Metabolic dysfunction-Associated Steatohepatitis (MASH)","Metabolic dysfunction-Associated Steatosis Liver Disease (MASLD)","2026-05-21",{"date":119,"type":36},"2026-05-26",{"date":121,"type":36},"2026-04-30",{"date":123,"type":20},"2026-10-30",{"name":42,"class":43},1,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":133,"minAge":17,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":21,"phases":136,"briefSummary":137,"conditions":138,"keywords":143,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},"100585743","phase-2-relacorilant-in-combination-with-different-treatment-regimens-in-patients-with-gynecological-cancers-100585743","NCT06906341","Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers","An Open-label, Global, Multi-Arm Study to Evaluate the Efficacy and Safety of Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers (BELLA)","Inclusion Criteria:\n\nArms A and B\n\n* Histologic diagnosis of epithelial ovarian, primary peritoneal, or fallopian-tube carcinoma\n* Arm A Only: Platinum-resistant disease\n* Arm B Only: Platinum-sensitive disease who had progression while receiving treatment with a poly(ADP-ribose) polymerase (PARP) inhibitor\n* Life expectancy of ≥3 months\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Able to swallow and retain oral medication\n* 1 to 3 lines of prior systemic anticancer therapy\n* Adequate organ function\n* Negative pregnancy test for patients of childbearing potential\n\nArm C\n\n* Stage III or IV, recurrent, or metastatic endometrial cancer\n* Life expectancy of ≥3 months\n* ECOG performance status of 0 or 1\n* Able to swallow and retain oral medication\n* Prior treatment with a platinum agent and an approved anti-Programmed Cell Death Ligand 1 (PD\\[L\\]1) antibody\n* 1 to 2 lines of prior systemic anticancer therapy for endometrial cancer\n* Must consent to provide an available formalin-fixed paraffin-embedded (FFPE) tumor tissue block or recently cut sections\n* Adequate organ function\n* Negative pregnancy test for patients of childbearing potential\n\nExclusion Criteria:\n\nArm A and B\n\n* Arm A Only: Has progressed while receiving weekly paclitaxel or nab-paclitaxel\n* Prior enrollment in a clinical trial of relacorilant\n* Prior anticancer therapy related toxicities not resolved to grade ≤1\n* Any surgery within 4 weeks prior to enrollment\n* Wide-field radiation to more than 25% of marrow-bearing areas\n* Medical conditions requiring chronic or frequent treatment with corticosteroids\n* Concurrent treatment with mifepristone or other glucocorticoid receptor modulators\n* Peripheral neuropathy from any cause \\>Grade 1\n* Hypertension: ≥150 mm Hg systolic or ≥100 mm Hg diastolic\n* Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient's safety or participation\n* Bowel obstruction ≤12 weeks prior to study entry\n* Ascites or pleural effusions requiring therapeutic paracentesis\n* Untreated or symptomatic central nervous system metastases\n* History of other malignancy within 3 years prior to enrollment\n* Has received a live vaccine within 30 days prior to the study start date\n\nArm C\n\n* Has progressed while receiving weekly paclitaxel or nab-paclitaxel\n* Prior enrollment in a clinical trial of relacorilant\n* Prior anticancer therapy related toxicities not resolved to grade ≤1\n* Any surgery within 4 weeks prior to enrollment\n* Wide-field radiation to more than 25% of marrow-bearing areas\n* Medical conditions requiring chronic or frequent treatment with corticosteroids\n* Concurrent treatment with mifepristone or other glucocorticoid receptor modulators\n* Peripheral neuropathy from any cause \\>Grade 1\n* Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient's safety or participation\n* Bowel obstruction ≤12 weeks prior to study entry\n* Ascites or pleural effusions requiring therapeutic paracentesis\n* History of other malignancy within 3 years prior to enrollment\n* Has received a live vaccine within 30 days prior to the study start date\n* Patients with central nervous system metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study.","FEMALE",{"count":135,"type":20},270,[24],"This is a Phase 2, open-label, global, multi-arm study to evaluate efficacy and safety of relacorilant in combination with other treatments in patients with gynecological cancers.",[139,140,141,142],"Ovarian Cancer","Fallopian Tube Cancer","Peritoneal Neoplasms","Endometrial Cancer",[144,145,146,147,27,148,149,141,150,151,152,153,154,155,156,157,158,159,160,161],"Genital Neoplasms, Female","Neoplasms by Site","Fallopian Tube Diseases","Ovarian Diseases","Fallopian Tube Neoplasms","Ovarian Neoplasms","Paclitaxel","Albumin-Bound Paclitaxel","Ovarian","Peritoneal or Advanced Fallopian Tube Cancer","High Grade","Platinum Resistant","Relacorilant","Bella","Nab-paclitaxel","Bevacizumab","Endometrial Neoplasm","Endometrial","2026-04-09",{"date":164,"type":36},"2026-04-14",{"date":166,"type":36},"2025-04-11",{"date":168,"type":20},"2026-12",{"name":42,"class":43},49,{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":104,"enrollmentInfo":178,"targetDuration":4,"studyType":21,"phases":180,"briefSummary":181,"conditions":182,"keywords":185,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":125},"100588891","phase-1-evaluation-of-miricorilant-on-liver-fat-in-patients-with-masld-100588891","NCT06947304","Evaluation of Miricorilant on Liver Fat in Patients With MASLD","A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Inclusion Criteria:\n\n* 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 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\u002FdL (5.6 mmol\u002FL) 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\u002FdL (1.7 mmol\u002FL) iv. Serum high-density lipoprotein cholesterol (HDL) \\\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 v. Having overweight or obesity (body mass index \\[BMI\\] ≥ 25 kg\u002Fm2 \\[BMI\n  * 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\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 \\\u003C 18 kg\u002Fm² or \\> 45 kg\u002Fm².\n* Significant alcohol consumption exceeding 20 g\u002Fday for women or 30 g\u002Fday 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",{"count":179,"type":20},8,[23],"A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients with Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)",[109,183,184,112],"Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)",[114,109,115,116],"2026-02-09",{"date":188,"type":36},"2026-02-11",{"date":190,"type":36},"2025-08-22",{"date":192,"type":20},"2026-05",{"name":42,"class":43},""]