[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645204":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":45,"collaborators":20,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":20,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":20,"studyType":61,"phases":62,"briefSummary":65,"conditions":66,"keywords":20,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dihydroartemisinin Treatment Arm","EXPERIMENTAL","All enrolled participants will receive the investigational intervention: oral Dihydroartemisinin tablets at a dose of 20 mg three times daily (TID) for 12 weeks. The drug is provided as 20mg tablets (Manufacturer: Beijing Fuyuan Pharmaceutical Co., Ltd.). This is followed by a 12-week post-treatment observational follow-up period.",[13],"Drug: Dihydroartemisinin",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Dihydroartemisinin","Oral Dihydroartemisinin tablets at a dose of 20 mg three times daily (TID) for 12 weeks",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Xuehao Wang, Doctor","CONTACT","86-025-68303211","Wangxh@njmu.edu.cn",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":20,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu 210029","RECRUITING","Nanjing","Jiangsu","China","CN",{"type":36,"coordinates":37},"Point",[38,39],118.77778,32.06167,{"lat":39,"lon":38},[42],{"name":43,"role":24,"phone":25,"phoneExt":20,"email":44},"Xuehao Wang","wangxh@njmu.edu.cn",{"type":46,"investigatorFullName":43,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Professor","100645204","phase-1-dihydroartemisinin-for-mafld-100645204",false,"NCT07679542","Dihydroartemisinin for MAFLD","A Single-Arm, Proof-of-Concept Study of Dihydroartemisinin in Adults With Metabolic Associated Fatty Liver Disease","Inclusion Criteria:\n\nAged 18-45 years (inclusive), any gender.\n\nMeets the diagnostic criteria for Metabolic Associated Fatty Liver Disease (MAFLD), requiring both of the following:\n\nEvidence of hepatic steatosis (at least one of the following):\n\nImaging: Ultrasound, CT, or MRI-PDFF showing liver fat content ≥5%.\n\nLiver biopsy: Histologically confirmed steatosis ≥5% (within 6 months prior to enrollment).\n\nFibroScan: Controlled Attenuation Parameter (CAP) ≥248 dB\u002Fm.\n\nEvidence of metabolic dysfunction (at least one of the following):\n\nOverweight\u002FObesity: BMI ≥24 kg\u002Fm² or waist circumference ≥90 cm (male) \u002F ≥85 cm (female).\n\nElevated blood pressure\u002FHypertension: Blood pressure ≥130\u002F85 mmHg, or on antihypertensive medication.\n\nPre-diabetes or Type 2 Diabetes: Fasting blood glucose ≥6.1 mmol\u002FL, or 2-hour post-load glucose ≥7.8 mmol\u002FL, or HbA1c ≥5.7%, or history of T2DM, or HOMA-IR ≥2.5.\n\nElevated blood triglycerides: Fasting serum TG ≥1.70 mmol\u002FL, or on lipid-lowering medication.\n\nReduced HDL-cholesterol: Serum HDL ≤1.0 mmol\u002FL (male) \u002F ≤1.3 mmol\u002FL (female), or on lipid-lowering medication.\n\nParticipants on glucose-, blood pressure-, or lipid-lowering medications must have been on a stable dose for at least 3 months prior to screening.\n\nAll participants must have stable body weight (defined as weight loss or gain not exceeding 5% within 3 months prior to screening and from screening to enrollment).\n\nVoluntary participation, willingness to cooperate with follow-up, and signed informed consent.\n\nExclusion Criteria:\n\nLiver function impairment (defined as any one of ALT, AST, GGT, ALP exceeding 2 times the upper limit of normal (ULN) and\u002For bilirubin exceeding 1.5 times ULN).\n\nLong-term use (exceeding 2 weeks) of drugs known to cause hepatic steatosis or fibrosis (e.g., glucocorticoids, valproate, methotrexate, tamoxifen, amiodarone, oral vitamin E) within the past year.\n\nExcessive alcohol consumption: weekly ethanol intake ≥210 g (male) or ≥140 g (female).\n\nPositive for Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibody (HCV-Ab).\n\nSpecific liver diseases that can cause fatty liver (e.g., autoimmune hepatitis, Wilson's disease) or other specific conditions (e.g., total parenteral nutrition, inflammatory bowel disease, celiac disease, hypothyroidism, Cushing's syndrome, abetalipoproteinemia, lipodystrophic diabetes, Mauriac syndrome).\n\nHistory of leukopenia or agranulocytosis.\n\nHistory of bariatric surgery within the past 2 years.\n\nPregnant, planning pregnancy, or lactating women.\n\nHistory of malignancy, cardiovascular disease, chronic kidney disease, decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy, hepatorenal syndrome), or liver transplantation.\n\nUse of any category of antibiotics within 2 weeks prior to enrollment.\n\nConsidered by the clinical investigator to be unsuitable for participation in the study.","ALL","18 Years","45 Years",{"count":59,"type":60},30,"ESTIMATED","INTERVENTIONAL",[63,64],"PHASE1","PHASE2","Brief Summary\n\nPurpose:\n\nThis is a proof-of-concept clinical trial to evaluate whether Dihydroartemisinin (DHA), a medication commonly used to treat malaria, can effectively reduce liver fat in adults with Metabolic Associated Fatty Liver Disease (MAFLD). The study will also rigorously assess the safety and tolerability of DHA in this specific patient population.\n\nStudy Design:\n\nThis is a single-center, open-label, single-arm study. All qualified participants will receive the investigational treatment, with each individual serving as their own baseline control to measure pre- and post-treatment changes. To minimize lifestyle-related confounding factors, all participants will receive standardized dietary and physical activity counseling at baseline and will be instructed to strictly maintain their established lifestyle routines throughout the study period.\n\nParticipants:\n\nThe study plans to enroll approximately 30 adult patients (ages 18 to 45 years) formally diagnosed with MAFLD. MAFLD is defined by the presence of excessive hepatic fat accumulation concurrent with specific metabolic dysfunctions, such as overweight\u002Fobesity, hypertension, elevated blood sugar, or dyslipidemia.\n\nIntervention:\n\nParticipants will be administered oral Dihydroartemisinin tablets at a dose of 20 mg three times daily (TID) for a continuous duration of 12 weeks. Upon completion of the intervention, participants will enter a 12-week observational follow-up period to monitor the durability of the treatment effects and long-term safety.\n\nMain Things We Will Measure (Outcomes):\n\nPrimary Outcome: Absolute change in liver fat content from baseline to the end of the 12-week treatment, quantitatively assessed by the gold-standard MRI Proton Density Fat Fraction (MRI-PDFF).\n\nSecondary Outcomes: Changes in supplementary non-invasive liver fat assessments (including Ultrasound-derived Fat Fraction \\[UDFF\\] and FibroScan Controlled Attenuation Parameter \\[CAP\\]), as well as changes in body weight, blood pressure, heart rate, and routine laboratory safety panels (e.g., comprehensive liver and kidney function tests).",[67],"MAFLD","2026-06-25",{"date":70,"type":71},"2026-07-01","ACTUAL",{"date":73,"type":71},"2026-03-30",{"date":75,"type":60},"2026-09-01",{"name":5,"class":6},1]