[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nafld-non-alcoholic-fatty-liver-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nafld-non-alcoholic-fatty-liver-disease":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100616664","phase-2-a-trial-to-evaluate-the-efficacy-safety-pk-and-pd-of-hp515-in-non---alcoholic-fatty-liver-disease--nashmash--100616664",false,"NCT07308548","A Trial to Evaluate the Efficacy, Safety, PK, and PD of HP515 in Non - Alcoholic Fatty Liver Disease ( NASH\u002FMASH )","A Phase IIa Clinical Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of HP515 Tablets in Participants With Non - Alcoholic Fatty Liver Disease","NASH\u002FMASH","Inclusion Criteria:\n\n1. Participants must voluntarily sign the informed consent form before the trial and fully understand the trial content, process, and possible adverse reactions.\n2. Participants must be aged between 18 and 65 years old, including those at the borderline age.\n3. At the screening stage, the liver fat fraction must be ≥ 10%\n4. Female participants must not donate eggs from the start of the screening until the end of the study and within 28 days after discontinuing the study drug; male participants must not donate sperm from the start of the screening until the end of the study and within 28 days after discontinuing the study drug.\n5. Participants must agree to use contraception during the study period and for the next 6 months after the last administration of the study drug, and must agree to continuously use effective contraceptive measures.\n\nExclusion Criteria:\n\n1. The participants have known or suspected allergic reactions\n2. Liver biopsy indicates cirrhosis or the participant has been clinically diagnosed with cirrhosis\n3. Type 1 diabetic patients or those with poorly controlled type 2 diabetes (HbA1c ≥ 8.0%);\n4. Suspected other liver and gallbladder diseases through medical history and laboratory tests, which, based on the investigator's judgment, may affect safety or efficacy evaluation\n5. Any abnormality in thyroid function tests with clinical significance or a previous history of thyroid disease\n6. Within the previous 1 year, had myocardial infarction, unstable angina pectoris, coronary artery bypass surgery, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage or transient ischemic attack, or other cardiovascular and cerebrovascular events that led to hospitalization;\n7. History of liver transplantation or planning to undergo liver transplantation;\n8. Had significant changes in diet or exercise habits in the past 2 months or a weight change of more than 5%;\n9. Participants who used drugs that changed the activity of CYP2C8 of liver enzymes within 4 weeks or 5 half-lives (whichever is longer), including strong inhibitors and inducers of liver metabolic enzymes;\n10. Pregnant or lactating women;\n11. Participants with contraindications to MRI scans;\n12. Participants judged by the investigator to be unsuitable for participation in the study.","ALL","18 Years","65 Years",{"count":21,"type":22},80,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Primary Objective:\n\n• To evaluate the efficacy of HP515 tablets in participants with non-alcoholic fatty liver disease.\n\nSecondary objectives:\n\n* To evaluate the safety of HP515 tablets in participants with non-alcoholic fatty liver disease;\n* To evaluate the pharmacokinetic of HP515 tablets in participants with non-alcoholic fatty liver disease;\n* To evaluate the pharmacodynamic effects of HP515 tablets in participants with non-alcoholic fatty liver disease;\n\nExploratory objective:\n\n• To evaluate the impact of HP515 tablets on target markers in participants with non-alcoholic fatty liver disease.\n\nThe study includes a screening period of 4 weeks, a treatment period of 12 weeks, and a safety follow-up period of 4 weeks.",[28],"NAFLD (Non-alcoholic Fatty Liver Disease)",[30,31],"non-alcoholic","Fatty Liver","RECRUITING","2025-12-19",{"date":35,"type":36},"2025-12-29","ACTUAL",{"date":38,"type":36},"2025-10-11",{"date":40,"type":22},"2026-12-31",{"name":42,"class":43},"Hinova Pharmaceuticals Inc.","INDUSTRY",2,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100602844","phase-1-a-safety-tolerability-and-pharmacokinetic-trial-of-multiple-subcutaneous-injections-of-b1344-injection-in-patients-with-nonalcoholic-fatty-liver-diseasenafld-100602844","NCT07128797","a Safety, Tolerability, and Pharmacokinetic Trial of Multiple Subcutaneous Injections of B1344 Injection in Patients With Nonalcoholic Fatty Liver Disease（NAFLD）","A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Phase Ib Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Subcutaneous Injections of B1344 Injection in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)","Inclusion Criteria:\n\n1. Chinese patients aged between 18 and 75 years;\n2. Patients diagnosed with NAFLD and with a magnetic resonance proton density fat fraction (MRI-PDFF) ≥10% in the screening\u002Fbaseline period or within one month prior;\n3. Presence of any one of the following metabolic risk factors:\n\n   * Body Mass Index (BMI) ≥24.0 kg\u002Fm² or abdominal obesity (male waist circumference ≥90 cm, female waist circumference ≥85 cm);\n   * Fasting blood glucose ≥6.1 mmol\u002FL, or 2-h blood glucose after glucose load ≥7.8 mmol\u002FL, or glycated hemoglobin (HbA1c) ≥5.7%, or history of type 2 diabetes, or Homeostasis Model Assessment Insulin Resistance Index (HOMA-IR) ≥2.5;\n   * Resting blood pressure ≥130\u002F85 mmHg, or currently receiving antihypertensive medication;\n   * Fasting serum triglycerides (TG) ≥1.70 mmol\u002FL, high-density lipoprotein cholesterol (HDL-c) ≤1.0 mmol\u002FL (male) and 1.3 mmol\u002FL (female), or currently receiving lipid-lowering medication.\n4. Weight stability reported by participants within 6 weeks before enrollment (absolute weight change ≤5%).\n5. Participants have no fertility plans within 3 months after signing the informed consent and voluntarily take effective contraceptive measures.\n6. Voluntary participation in the clinical trial, able to sign the informed consent, and capable of understanding and complying with the trial procedures.\n\nExclusion Criteria:\n\n1. Liver biopsy, or clinical diagnosis of cirrhosis based on clinical presentation, biochemical and imaging results, or any of the following criteria: ① FIB-4 score ≥3.48 in the screening\u002Fbaseline period or within 1 month prior, or liver stiffness value (LSM) ≥15 kPa based on FibroScan; ② liver biopsy results indicating NASH-F4 stage within the previous 24 months; ③ clinical examination signs of liver cirrhosis or splenomegaly during the screening\u002Fbaseline period; ④ abdominal imaging results showing liver nodules or splenomegaly during the screening\u002Fbaseline period or within 1 month prior.\n2. History of tumors or liver transplantation, or patients planning to undergo liver transplantation.\n3. History of liver diseases other than NAFLD or clinical suspicion of liver diseases other than NAFLD, including but not limited to secondary NAFLD, hepatitis B, hepatitis C, autoimmune hepatitis, hemochromatosis, alcoholic liver disease, primary sclerosing cholangitis, primary biliary cholangitis, or Wilson's disease.\n4. History of other diabetes besides T2DM (such as type 1 diabetes, secondary diabetes, etc.), or currently using or planning to use insulin, thiazolidinediones, and glucagon-like peptide-1 (GLP-1) analog drugs for treatment.\n5. Presence of other severe, progressive, or uncontrolled diseases besides T2DM, hypertension, and dyslipidemia, including but not limited to immune system, endocrine system, hematologic system, urinary system, hepatobiliary system, respiratory system, nervous system, psychiatric system, cardiovascular system, digestive system, where participation in this trial would increase participant risk as determined by the investigator.\n6. Previous history of weight-loss surgery or plans for weight-loss during the trial, or significant changes in exercise or dietary habits.\n7. History of extra-bone injury, fracture, or bone-related surgery within 2 months before screening.\n8. Participants with a history of long QT syndrome or family history of sudden death, or males with QTcF \\> 450 ms, females with QTcF \\> 470 ms.\n9. Allergic to B1344 or its excipients, or history of allergy to other biological products or severe allergic reactions.\n10. History of drug use related to secondary NAFLD lasting more than 2 weeks within 12 months before screening, including amiodarone, methotrexate, systemic corticosteroids, 5-fluorouracil, irinotecan, tetracycline, tamoxifen, doses exceeding hormone replacement estrogen, anabolic steroids, valproic acid, and other known hepatotoxic drugs.\n11. History of concomitant treatment that does not meet protocol requirements before enrollment, or concomitant treatment that meets protocol requirements but cannot maintain a stable dose until the end of the trial, or plans to initiate new concomitant treatments after the first dose until the end of the trial.\n12. Previous use of FGF-21 analogs or FGFR1 agonists.\n13. Screening\u002Fbaseline examination results meeting the following criteria:\n\n    * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 times the upper limit of normal (ULN), total bilirubin \\>ULN;\n    * Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73m²;\n    * Hemoglobin \\\u003C120 g\u002FL (male) or \\\u003C110 g\u002FL (female);\n    * HbA1c ≥9%; fasting blood glucose ≥13.9 mmol\u002FL;\n    * International normalized ratio (INR) \\>1.3;\n    * Platelet count \\\u003C110×10⁹\u002FL;\n    * Dual-energy X-ray absorptiometry (DXA) T-score ≤-2.5;\n    * Resting systolic blood pressure \\\u003C90 or ≥160 mmHg, resting diastolic blood pressure \\\u003C50 or ≥100 mmHg;\n    * Resting heart rate \\\u003C60 or \\>100 beats\u002Fminute;\n    * TG ≥5.65 mmol\u002FL;\n    * Hepatitis B surface antigen (HBsAg) positive, hepatitis C antibody (HCVAb) positive, human immunodeficiency virus (HIV) antibody positive, or positive for serum Treponema pallidum specific antibody (TP-Ab).\n14. History of long-term excessive alcohol consumption, or alcohol consumption ≥14 World Health Organization (WHO) alcohol units per week (1 WHO alcohol unit = 10 g pure alcohol) within 3 months before screening, or positive alcohol screening, or unable to refrain from alcohol 48 hours before the first dose until the end of the trial.\n15. Excessive consumption of tea, coffee, or caffeinated beverages (daily consumption of more than 8 cups of respective drinks, with 1 cup being 250 mL) within 3 months before screening, or consumption of any caffeinated food or drink (such as coffee, strong tea, chocolate, cola, etc.) within 48 hours before the first dose.\n16. History of blood donation, loss of blood ≥200 mL, blood transfusion, or use of blood products within 3 months before screening, or plans to donate blood during the trial.\n17. History of needle phobia, blood phobia, or frequent episodes of orthostatic hypotension, or inability to tolerate venipuncture.\n18. History of drug abuse, or positive urine drug abuse screening.\n19. Smoking more than 5 cigarettes daily within the last 3 months or cannot completely quit smoking during the trial.\n20. Women who are pregnant or breastfeeding, or planning to become pregnant or breastfeed during the trial.\n21. Any skin or abdominal wall anomalies that would affect subcutaneous injection, or tattoos or scars covering more than 50% of the abdominal wall surface area.\n22. Participation in other clinical trials and receiving trial interventions within the last 3 months.\n23. Existing MRI examination contraindications or inability to cooperate with MRI examinations before screening.\n24. Other circumstances deemed unsuitable for participation in this trial by the investigator.","75 Years",{"count":54,"type":22},32,[56],"PHASE1","This is a randomized, double-blind, multicenter, placebo-controlled, multiple-dose escalating clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity profile of B1344 in patients with NAFLD. Additionally, the trial will conduct preliminary observations on the efficacy of B1344, aiming to provide early proof of concept for B1344 as a therapeutic agent for NASH.",[28,59],"NASH (Nonalcoholic Steatohepatitis)","2025-08-18",{"date":62,"type":36},"2025-08-19",{"date":64,"type":36},"2025-07-24",{"date":66,"type":22},"2026-07",{"name":68,"class":43},"Tasly Biopharmaceuticals Co., Ltd.",5,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":83,"conditions":84,"keywords":94,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":5},"100600119","the-impact-of-pectin-supplementation-on-systematic-inflammation-pathway-gut-microbiome-and-metabolic-health-in-patients-with-metabolic-dysfunction-associated-steatotic-liver-disease-masld-100600119","NCT07093346","The Impact of Pectin Supplementation on Systematic Inflammation Pathway, Gut Microbiome, and Metabolic Health in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","The Impact of Pectin Supplementation on Systematic Inflammation Pathway, Gut Microbiome, and Metabolic Health in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Randomised, Placebo-Controlled, Dietary Intervention Study","PEC-MASLD","Inclusion Criteria:\n\nInclusion criteria for the main study:\n\n* Patients with clinical diagnosis of MASLD (formerly termed non-alcoholic fatty liver disease (NAFLD)), having assessment suggesting that liver fat \\> 5% (e.g. histological evidence or\u002F and Transient Elastography using Controlled Attenuation Parameter (CAP)- FibroScan™ in the past month and\u002For liver imaging (such as ultrasound, computerized tomography (CT) or magnetic resonance imaging (MRI)).\n* Participants willing and able to give informed consent for participation in the study.\n* Participants aged ≥18 years who have a body mass index (BMI) between 18.5 and 39.9 kg\u002Fm2 and stable weight (weight gain or loss ≤ 3kg) for the past 3 months.\n* For diabetic participants: controlled blood glucose levels Haemoglobin A1C (HbA1c) \\\u003C7.0% (\\\u003C53 mmol\u002Fmol) \\[1\\].\n* Able to undergo CAP-FibroScan™.\n\nInclusion criteria for healthy participants who will have MRI scans:\n\n* Participants willing and able to give informed consent for participation in the study.\n* Participants aged ≥18 years.\n* participants with CAP\\\u003C250 kpa\\\u003C8kP by a FibroScan™ within the past 6 months.\n\nExclusion Criteria:\n\nExclusion criteria for the main study:\n\n* Have allergy toward soya, milk or chocolate.\n* Have allergy toward pectin.\n* Participants on vegan diet.\n* Have eating disorders or difficulties or gastrointestinal conditions e.g. malabsorptive conditions such as coeliac, Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD) or gastroparesis.\n* Have chronic malnutrition condition.\n* History of major surgery which potentially limits participation or completion of the study.\n* History of previous intestinal surgery known to affect food intake or digestive function, including bariatric surgery.\n* Use of antibiotics, antifungal medications, probiotics or prebiotics 90 days before the start of the study.\n* Are taking the following medications: immunosuppressants, amiodarone and\u002For perhexiline.\n* Are currently following or anticipated to commence a specialised commercially available weight loss diet and\u002For program or concomitant use of any weight loss medication or herbal weight loss products.\n* History of side effects towards probiotics or prebiotics.\n* History or current psychiatric illness.\n* History or current neurological condition (e.g. epilepsy).\n* Participants with other liver abnormalities.\n* Evidence of monogenic metabolism diseases such as Lysosomal acid lipase deficiency (LALD), Wilson disease, Hypobetalipoproteinemia, or inborn errors of metabolism.\n* Have had a weight change exceeding 3 kg within 3 months.\n* Uncontrolled diabetes, active malignancy, or chronic infections.\n* Having symptoms of active infection.\n* Excessive alcohol intake defined as self-reported intakes greater than 21 units per week in men, and 14 units per week in women.\n* Participants who are pregnant, breast feeding or actively planning pregnancy will be excluded from the study.\n* Participation in any other trial in the last 3 months.\n\nExclusion criteria for healthy volunteers MRI scans and patients optional MRI scans:\n\n* Contraindications for MRI scanning: having pacemakers, defibrillators, neurostimulators, prohibited medical implants, and foreign bodies (e.g. bullets, shrapnel, metal slivers), history of metallic foreign body in eye(s) and penetrating eye injury that could present a risk during an MRI scan.\n* Difficulty breathing or inability to lie flat, as well as conditions that could worsen under stress (such as anxiety or panic disorders, claustrophobia, uncontrolled hypertension, or seizure disorders) severe enough to prevent undergoing an MRI.",true,{"count":80,"type":22},45,[82],"NA","The goal of this clinical trial is to learn if daily supplementation with Low-methoxy (LM) pectin (polysaccharides extracted from citrus peels), which are commonly found in the UK diet (not pharmacological agents), can reduce systemic inflammation and improve gut microbiota composition in adults recently diagnosed with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). The main question it aims to answer is:\n\n-How does dietary Low-methoxy (LM) pectin supplementation affect systematic inflammation pathways such as those mediated by gut microbiota composition and what are the impacts on general metabolic indicators in individuals with MASLD?\n\nResearchers will compare a group taking 15g of LM-pectin with 10g of cocoa powder to a placebo group receiving 10g of placebo with 10g of cocoa powder to see if LM-pectin has measurable effects on inflammation and gut microbiota.\n\nParticipants will:\n\n* Take a daily supplement for 6 weeks: either 15g of LM-pectin with 10g of cocoa powder (intervention), or 10g of placebo with 10g of cocoa powder (control)\n* Provide stool and fasting blood samples before and after the intervention\n* Undergo anthropometric measurements (weight, height, waist\u002Fhip ratio, and blood pressure)\n* Complete a case report form (CRF) including demographics and health\u002Fmedical history\n* Undergo a FibroScan™ to assess liver health\n* (Optional) Participate in MRI scans to evaluate gut permeability",[85,86,87,88,89,90,91,28,92,93],"Nonalcoholic Fatty Liver Disease","Nonalcoholic Fatty Liver Disease (NAFLD)","MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease","MASLD","NAFLD","Metabolic Dysfunction-Associated Steatotic Liver Disease","NAFLD (Nonalcoholic Fatty Liver Disease)","NAFLD - Non-Alcoholic Fatty Liver Disease","NAFLD - Nonalcoholic Fatty Liver Disease",[95,96,88,89,85,97,98,99,100,101,90],"LM pectin","pectin","Systemic Inflammatory Response","Dietary Fiber","Dietary Fibre","Diet","gut microbiota","2025-07-22",{"date":104,"type":36},"2025-07-30",{"date":106,"type":36},"2025-06-10",{"date":108,"type":22},"2027-03-31",{"name":110,"class":111},"University of Nottingham","OTHER"]