[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alcohol-liver-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alcohol-liver-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"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},"100593701","phase-2-restore-trial-a-phase-2-study-evaluating-the-efficacy-and-safety-of-pemvidutide-in-the-treatment-of-alcohol-associated-liver-disease-ald-100593701",false,"NCT07009860","RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)","RESTORE TRIAL: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)","Inclusion Criteria:\n\n1. Male or female ages 18 to 75 years, inclusive\n2. Overweight or obesity, defined as BMI ≥ 25 kg\u002Fm2\n3. History of alcohol misuse for the prior 3 years, with an alcohol intake ≥ 50 grams per day for males and ≥ 40 grams per day for females on average in the past year\n4. Liver stiffness of 10.0-18.5 kPa by VCTE, inclusive\n\nExclusion Criteria:\n\n1. Presence of clinically significant alcohol withdrawal symptoms, defined as CIWA-Ar score ≥ 10 at screening and\u002For prior to randomization\n2. History of hospitalization for alcohol intoxication or alcohol withdrawal within the past year\n3. History of seizures related to alcohol within the past year\n4. History and\u002For current DSM-5 diagnosis of schizophrenia, bipolar disorder, psychotic disorder, or another severe psychiatric disorder, unless documented as well-controlled by the Investigator for at least 6 months prior to screening and cleared by the Medical Monitor","ALL","18 Years","75 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in subjects with ALD.\n\n* Pemvidutide: 2.4 mg SC once weekly\n* Placebo: Placebo SC once weekly",[27],"Alcohol Liver Disease","RECRUITING","2026-03-19",{"date":31,"type":32},"2026-03-20","ACTUAL",{"date":34,"type":32},"2025-06-16",{"date":36,"type":21},"2027-08-31",{"name":38,"class":39},"Altimmune, Inc.","INDUSTRY",43,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":51,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100577384","clinical-correlation-evaluation-of-the-liverfast-test-for-diagnosing-important-liver-lesions-of-fibrosis-and-steatosis-against-magnetic-resonance-elastography-mre-for-liver-fibrosis-and-mr-based-assessment-of-steatosis-in-adult-us-population-100577384","NCT06797596","Clinical Correlation Evaluation of the LIVERFASt Test for Diagnosing Important Liver Lesions of Fibrosis and Steatosis Against Magnetic Resonance Elastography (MRE) for Liver Fibrosis and MR-based Assessment of Steatosis, in Adult US Population.","Clinical Correlation Evaluation of the LIVERFAStTM Test for Diagnosing Important Liver Lesions of Fibrosis and Steatosis Against MR-based Liver Assessment, Magnetic Resonance Elastography (MRE) for Liver Fibrosis and MR-based Assessment of Steatosis, in Adult US Population.","LFMRECT","Inclusion Criteria:\n\n* SLD with MASLD or MetALD Adult patients with:\n\n  * available historical report of MRE and LIVERFASt test\n  * at least fibrosis scoring available (steatosis and necro-inflammation imaging reports are requested equally when available).\n* Other imaging modality reports ie. MRI, ARFI, ct1, SWE and Fibroscan can be included when available\n\nExclusion Criteria:\n\n* Participants identified as having risk factors for false positive\u002Fnegative results for Liverfast (severe intravascular hemolysis-if condition is known-, acute hepatitis or severe cytolysis with ≥ 600 ALT values)\n* Other comorbidities not compatible with the diagnosis of MASLD or MetALD","90 Years",{"count":20,"type":21},"2 Days","OBSERVATIONAL","This is a retrospective cross-sectional research intended to explore the utility of LIVERFASt in the clinical pathways for the detection of liver fibrosis and steatosis in comparison with the Magnetic Resonance Elastography (MRE) and MRct1 fibrosis classification (historical records) and to assess LIVERFASt performance for MR steatosis assessment in an United States adult miscellaneous population with available (historical) MR intracellular fat fraction assessment (ICFF) from a single tertiary US clinic.",[55,56,27],"Liver Fibrosis Due to NASH","MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease",[58,59,60,61,62,63,64,65,66,67,68,69,70],"LIVERFASt","LIVERFASt Test","Noninvasive Test for the Liver","LIVERFASt for MASLD","LIVERFASt for MASH","Fibronostics","Liverfast fibrosis test","Liverfast steatosis test","Liverfast for MASLD and MASH","Liverfast for liver fibrosis","Liverfast plus MRE","Liverfast and MRE","Liverfast and other imaging tools","NOT_YET_RECRUITING","2025-03-10",{"date":74,"type":32},"2025-03-13",{"date":76,"type":21},"2025-05",{"date":78,"type":21},"2025-08-30",{"name":80,"class":81},"Fibronostics USA, Inc","OTHER",1]