Nctid:
NCT06613698
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D008107", "term"=>"Liver Diseases"}, {"id"=>"D008108", "term"=>"Liver Diseases, Alcoholic"}], "ancestors"=>[{"id"=>"D004066", "term"=>"Digestive System Diseases"}, {"id"=>"D020751", "term"=>"Alcohol-Induced Disorders"}, {"id"=>"D019973", "term"=>"Alcohol-Related Disorders"}, {"id"=>"D019966", "term"=>"Substance-Related Disorders"}, {"id"=>"D064419", "term"=>"Chemically-Induced Disorders"}], "browseLeaves"=>[{"id"=>"M11107", "name"=>"Liver Diseases", "asFound"=>"Liver Disease", "relevance"=>"HIGH"}, {"id"=>"M8375", "name"=>"Fatty Liver", "relevance"=>"LOW"}, {"id"=>"M11108", "name"=>"Liver Diseases, Alcoholic", "asFound"=>"Liver Diseases, Alcoholic", "relevance"=>"HIGH"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M22508", "name"=>"Alcohol-Induced Disorders", "relevance"=>"LOW"}, {"id"=>"M21842", "name"=>"Alcohol-Related Disorders", "relevance"=>"LOW"}, {"id"=>"M21837", "name"=>"Substance-Related Disorders", "relevance"=>"LOW"}, {"id"=>"M30302", "name"=>"Chemically-Induced Disorders", "relevance"=>"LOW"}, {"id"=>"T5868", "name"=>"Visceral Steatosis", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Substance Related Disorders", "abbrev"=>"BC25"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M3777", "name"=>"Ethanol", "relevance"=>"LOW"}, {"id"=>"M11110", "name"=>"Liver Extracts", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Hematinics", "abbrev"=>"Hemat"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SEQUENTIAL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>393}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-09-27", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2027-03-10", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-23", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-12-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Number of participants with adverse events (AEs) and serious adverse events (SAEs)", "timeFrame"=>"Up to 8 weeks"}, {"measure"=>"Number of participants with potentially clinically relevant changes in electrocardiogram (ECG), vital signs, and clinical laboratory tests", "timeFrame"=>"Up to 8 weeks"}, {"measure"=>"Change from baseline in Liver Stiffness measurement (LSM) reduction using FibroScan® at Week 28 (kiloPascal)", "timeFrame"=>"Baseline (Day 1) and up to Week 28", "description"=>"Liver stiffness will be measured by vibration-controlled transient elastography (VCTE) using the FibroScan® device."}, {"measure"=>"Change from baseline in model for end-stage liver disease (MELD) score reduction at Week 28", "timeFrame"=>"Baseline (Day 1) and up to Week 28", "description"=>"MELD is a scoring system for assessing the severity of chronic liver disease. MELD scores range between 6 and 40, with 40 being the most severe."}], "secondaryOutcomes"=>[{"measure"=>"Maximum plasma concentration (Cmax) of GSK4532990", "timeFrame"=>"Up to Day 4"}, {"measure"=>"Area Under the Curve from Time 0 to t [AUC (0-t)] of GSK4532990", "timeFrame"=>"Up to Day 4"}, {"measure"=>"Area Under the Curve from Time 0 to 24 hours [AUC (0-24)] of GSK4532990", "timeFrame"=>"Up to 24 hours"}, {"measure"=>"Plasma half-life (t1/2) of GSK4532990", "timeFrame"=>"Up to Day 4"}, {"measure"=>"Apparent clearance (CL/F) of GSK4532990", "timeFrame"=>"Up to Day 4"}, {"measure"=>"Time to maximum concentration (tmax) of GSK4532990", "timeFrame"=>"Up to Day 4"}, {"measure"=>"Apparent terminal phase volume of distribution (Vz/F) of GSK4532990", "timeFrame"=>"Up to Day 4"}, {"measure"=>"Change from baseline in serum AST at Week 28", "timeFrame"=>"Baseline (Day 1), and at Week28"}, {"measure"=>"Change from baseline in Enhanced Liver Fibrosis (ELF™) score at Week 28", "timeFrame"=>"Baseline (Day 1), and at Week 28", "description"=>"The ELF™ score will be calculated using a published algorithm combining the values of a set of extracellular matrix markers, including tissue inhibitor of metalloproteinases-1 (TIMP-1), type III procollagen (PIIINP), and hyaluronic acid (HA). The ELF™ score is used as a prognostic marker for disease progression. ELF™ score will range between 4.5 to 14.7. A higher ELF™ score will predict worse prognosis"}, {"measure"=>"Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of GSK4532990", "timeFrame"=>"Up to Day 3"}, {"measure"=>"Maximum observed plasma concentration (Cmax) of GSK4532990", "timeFrame"=>"Up to Day 3"}]}, "oversightModule"=>{"isUsExport"=>true, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["GSK4532990", "Alcohol-related liver disease", "Steatohepatitis"], "conditions"=>["Liver Diseases, Alcoholic"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this study is to assess the safety and efficacy of GSK4532990 in participants with alcohol-related liver disease."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Capable of giving signed informed consent prior to the performance of any study-specific procedures.\n* Able and willing to comply with all study assessments and adhere to the protocol schedule of activities.\n* In the opinion of the investigator, there is a history of alcohol consumption compatible with either ALD or Met ALD.\n* A female participant is eligible to participate after meeting additional pre-defined criteria.\n* Participants must meet predefined stable use requirements of concomitant medications based on study criteria.\n\nExclusion Criteria:\n\n* Meeting any definition of organ system failure as defined by the North American Consortium for Study of End-stage Liver Disease (NACSELD)\n* Exceeding pre-defined biochemical parameters for Alanine Aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline Phosphatase (ALP), Platelets, International normalised ratio (INR), Albumin, estimated glomerular filtration rate (eGFR), Urine albumin-creatinine ratio (UACR) or Glycosylated Hemoglobin (HbA1c). Other primary causes of liver disease based on study criteria.\n* Current or ongoing malignancy (except for basal cell carcinoma or uterine carcinoma-in-situ) at screening. Participants under evaluation for possible malignancy at screening are not eligible.\n* Prior liver transplant or current listing for liver transplant during the screening period.\n* Chronic or acute, including partial, known portal vein thrombosis.\n* Prior transjugular intrahepatic portosystemic shunt (TIPSS) insertion.\n* Any acute cardiovascular event including myocardial infarction, unstable angina, symptomatic heart failure, or cerebrovascular accident in the 6 months prior to screening.\n* Poorly controlled hypertension\n* Clinical suspicion of rhabdomyolysis during the screening period\n* Clinical suspicion of a bleeding episode during the screening period related to portal hypertension and/or low blood fibrinogen level.\n* Body Mass Index (BMI) \\>35 kg/m2 at screening"}, "identificationModule"=>{"nctId"=>"NCT06613698", "acronym"=>"STARLIGHT", "briefTitle"=>"A Study to Investigate the Safety and Efficacy of GSK4532990 Compared With Placebo in Adult Participants Aged 18 to 65 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"type"=>"DRUG", "description"=>"GSK4532990 will be administered", "armGroupLabels"=>["GSK4532990 Dose 1", "GSK4532990 Dose 2", "GSK4532990 Dose 3", "GSK4532990 Dose 4"]}, {"name"=>"Placebo", "type"=>"DRUG", "description"=>"Placebo will be administered", "armGroupLabels"=>["Placebo"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"85224", "city"=>"Chandler", "state"=>"Arizona", "country"=>"United States", "contacts"=>[{"name"=>"US GSK Clinical Trials Call Center", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"877-379-3718"}, {"name"=>"EU GSK Clinical Trials Call Centre", "role"=>"CONTACT", "email"=>"GSKClinicalSupportHD@gsk.com", "phone"=>"+44 (0) 20 8990 4466"}, {"name"=>"Anita Kohli", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"GSK Investigational Site", "geoPoint"=>{"lat"=>33.30616, "lon"=>-111.84125}}, {"zip"=>"85006", "city"=>"Phoenix", "state"=>"Arizona", "country"=>"United States", "contacts"=>[{"name"=>"US GSK Clinical Trials Call Center", 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