[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639643":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":11,"centralContacts":53,"locations":11,"responsibleParty":59,"collaborators":11,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":11,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":11,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":11,"overallStatus":80,"whyStopped":11,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":11},{"fullName":5,"class":6},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY",[8,14,18,22,27,31],{"label":9,"type":10,"description":11,"interventionNames":12},"QL2401 25 mg","EXPERIMENTAL",null,[13],"Drug: QL2401 25 mg",{"label":15,"type":10,"description":11,"interventionNames":16},"QL2401 50 mg",[17],"Drug: QL2401 50 mg",{"label":19,"type":10,"description":11,"interventionNames":20},"QL2401 100 mg",[21],"Drug: QL2401 100 mg",{"label":23,"type":24,"description":11,"interventionNames":25},"QL2401 placebo 25 mg","PLACEBO_COMPARATOR",[26],"Drug: QL2401 placebo 25 mg",{"label":28,"type":24,"description":11,"interventionNames":29},"QL2401 placebo 50 mg",[30],"Drug: QL2401 placebo 50 mg",{"label":32,"type":24,"description":11,"interventionNames":33},"QL2401 placebo 100 mg",[34],"Drug: QL2401 placebo 100 mg",[36,40,43,46,49,51],{"type":37,"name":9,"description":38,"armGroupLabels":39,"otherNames":11},"DRUG","QL2401 is a recombinant fusion protein administered via subcutaneous injection. Participants will receive QL2401 25 mg, once-weekly for 48 weeks.",[9],{"type":37,"name":15,"description":41,"armGroupLabels":42,"otherNames":11},"QL2401 is a recombinant fusion protein administered via subcutaneous injection. Participants will receive QL2401 50 mg, once-weekly for 48 weeks.",[15],{"type":37,"name":19,"description":44,"armGroupLabels":45,"otherNames":11},"QL2401 is a recombinant fusion protein administered via subcutaneous injection. Participants will receive QL2401 100 mg, once-weekly for 48 weeks.",[19],{"type":37,"name":23,"description":47,"armGroupLabels":48,"otherNames":11},"Matching placebo administered via subcutaneous injection, once-weekly for 48 weeks.",[23],{"type":37,"name":28,"description":47,"armGroupLabels":50,"otherNames":11},[28],{"type":37,"name":32,"description":47,"armGroupLabels":52,"otherNames":11},[32],[54],{"name":55,"role":56,"phone":57,"phoneExt":11,"email":58},"Dandan Guo, Master","CONTACT","+86-0531-55821372","dandan1.guo@qilu-pharma.com",{"type":60,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100639643","phase-2-to-evaluate-the-efficacy-and-safety-of-ql2401-in-patients-with-metabolic-dysfunction-associated-steatohepatitis-and-liver-fibrosis-f2-f3-100639643",false,"NCT07620366","To Evaluate the Efficacy and Safety of QL2401 in Patients With Metabolic Dysfunction-associated Steatohepatitis and Liver Fibrosis (F2-F3)","A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of QL2401 in Patients With Metabolic Dysfunction-associated Steatohepatitis and Liver Fibrosis (F2-F3).","Inclusion Criteria:\n\n1. Males and females between 18 - 75 years of age inclusive, based on the date of signation of ICF.\n2. Presence of type 2 diabetes, or diagnosed at least 1 diseases of obesity, dyslipidemia, hypertension, elevated fasting glucose.\n3. Any one criterion as follow:\n\n   * Liver biopsy proved MASH (NAS ≥ 4 with steatosis, ballooning degeneration and lobular inflammation ≥ 1) with fibrosis stage 2 to 3 at screening or within 6 months; or\n   * VCTE measured liver stiffness 8.0 kPa ≤ LSM \\\u003C 20.0 kPa, CAP\\>302 dB\u002Fm.\n4. Hepatic fat fraction \\> 10% measured by MRI-PDFF at screening or within 3 months.\n5. Participants using weight loss, blood sugar-lowering, or lipid-regulating medications must maintain a stable dose for ≥3 months before randomization.\n6. Participants maintain a stable body weight (±5%) within 2 months prior screening.\n\nExclusion Criteria:\n\n1. Currently or prior history of hepatocellular carcinoma.\n2. Previous or planned liver transplant.\n3. History or evidence of any acute or chronic liver disease other than MASH.\n4. Cirrhosis with histological records available during screening or prior biopsy (stage 4 fibrosis).\n\nOther inclusion and exclusion criteria may apply.","ALL","18 Years","80 Years",{"count":72,"type":73},132,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-design clinical trial to evaluate efficacy and safety of QL2401 in patients with metabolic dysfunction-associated steatohepatitis and liver fibrosis (F2-F3).",[79],"Metabolic Dysfunction-associated Steatohepatitis (MASH)","NOT_YET_RECRUITING","2026-05-27",{"date":83,"type":84},"2026-06-02","ACTUAL",{"date":86,"type":73},"2026-06",{"date":88,"type":73},"2028-03",{"name":5,"class":6}]