[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Rivus Pharmaceuticals, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100630729","phase-2-a-trial-to-investigate-safety-exposure-and-efficacy-of-hu6-compared-with-placebo-in-adult-participants-with-metabolic-dysfunction-associated-steatohepatitis-mash-100630729",false,"NCT07491458","A Trial to Investigate Safety, Exposure, and Efficacy of HU6 Compared With Placebo in Adult Participants With Metabolic Dysfunction-associated Steatohepatitis (MASH)","A Parallel Treatment Group, Phase 2a, Double-blind, 4-arm Trial to Evaluate the Safety, Exposure, and Efficacy of HU6 Compared With Placebo in Male and Female Participants Aged 30 Years or Older With Metabolic Dysfunction-associated Steatohepatitis (MASH)","AMPLIFY","Inclusion Criteria:\n\n* Male and female ≥30 years of age at time of signing the informed consent.\n* Diagnosed with metabolic dysfunction-associated steatohepatitis (MASH)\n* Women of childbearing potential must not be pregnant or breastfeeding and must use and agree to continue to use a highly effective contraceptive method throughout time on study.\n* Body Mass Index (BMI) ≥27.0 kg\u002Fm2 to ≤44 kg\u002Fm2\n\nExclusion Criteria:\n\n* Have acute or chronic hepatitis, signs, and symptoms of any other liver disease (eg, Wilson's disease) other than MASH\n* Cholecystectomy or any other surgical or medical condition or history that may potentially alter the absorption, metabolism, or excretion of study treatment.\n* History (including any family history) of malignant hyperthermia.\n* History of malignancy within 5 years (except cutaneous basal or squamous cell carcinoma, carcinoma-in-situ, or low-grade prostate cancer).\n* History of the following cardiovascular conditions within 3 months prior to randomization: acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, hospitalization due to congestive heart failure (CHF), or acute CHF.\n* Significant and unstable lung disease (chronic obstructive pulmonary disease \\[COPD\\], emphysema, pulmonary fibrosis, or asthma) requiring oxygen or chronic daily medication. Note that mild, stable COPD and asthma on inhalers are allowed.\n* Monogenetic diabetes or type 1 diabetes.\n* History of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to Screening.\n* History of agranulocytosis.\n* History of or active evidence of ophthalmological conditions\n* Untreated, uncontrolled, or unstable hypertension\n* Use of any of the following medications\u002Ftherapies: Vitamin E: use of ursodiol or high-dose vitamin E (\\>400 IU\u002Fday) for a duration of \\>1 month within 6 months or started high dose vitamin E for any duration within 3 months prior to screening\n* Within 3 months prior to screening or plan to use prior to coming off study drug: resmetirom (Rezdiffra®), GLP 1 agonists and gastric inhibitory polypeptide (GIP)\u002FGLP-1 agonists, Weight loss medications\u002Ftherapies including: herbal preparation, over the counter (OTC) drug, mail order or prescription drug, Oral antidiabetic medications\u002Ftherapies including: insulin, meglitinides, thiazolidinediones. Prescription or OTC stimulants. Recent or current use of obeticholic acid (Ocaliva®), systemic corticosteroids, methotrexate, tamoxifen, amiodarone, or long-term use of tetracyclines. Warfarin, heparin, factor Xa inhibitors due to risk of bleeding, Medications with high risk of idiosyncratic drug-induced neutropenia (IDIN) or agranulocytosis.\n* History of hepatitis or human immunodeficiency virus (HIV1 \\& HIV2)\n* Intolerance to MRI or with conditions contraindicated for MRI procedures\n* Participation in another clinical trial at the time of screening or exposure to any investigational product, including topical agents, within 28 days prior to starting study treatment\n* Additional inclusion\u002Fexclusion criteria could apply","ALL","30 Years",{"count":20,"type":21},180,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Rivus Pharmaceuticals. Inc. is sponsoring this research study to assess the safety and tolerability of HU6 as a possible treatment for patients diagnosed with metabolic dysfunction-associated steatohepatitis (MASH). The study will also assess safety, pharmacokinetics (PK) and changes in liver fat content related to patients diagnosed with MASH.",[27],"MASH - Metabolic Dysfunction-Associated Steatohepatitis","RECRUITING","2026-05-14",{"date":31,"type":32},"2026-05-18","ACTUAL",{"date":34,"type":32},"2026-02-13",{"date":36,"type":21},"2028-02",{"name":38,"class":39},"Rivus Pharmaceuticals, Inc.","INDUSTRY",31,""]