[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metabolic-associated-steatotic-liver-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metabolic-associated-steatotic-liver-disease":128},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,51,64,99],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100054144",false,"NCT07313787","Effects of Meal Macronutrients on Postprandial Lipids","Prospective Cross-Over Study of the Effects of Meal Macronutrients on Postprandial Lipids","* INCLUSION CRITERIA:\n\nCommon inclusion criteria (all groups):\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Age \\>= 18 years\n2. Average alcohol intake in the past 6 months \\\u003C 3 drinks (approximately 30g) per day (male) or \\\u003C 2 drinks (approximately 20 g) per day (female)\n\nHealthy control specific inclusion criteria:\n\n1. In good general health with no known active medical conditions as evidenced by medical history\n2. Fasting glucose \\\u003C100 mg\u002FdL\n3. HbA1c \\\u003C5.7%\n4. Fasting triglycerides \\\u003C150 mg\u002FdL\n5. ALT and AST within normal limits\n6. BMI \\>=18.5 to \\\u003C25 kg\u002Fm\\^2 (or \\\u003C23 kg\u002Fm\\^2 in participants of Asian descent)\n7. Not taking any medications or supplements that, in the opinion of the investigator, would interfere with interpretation of study data.\n\nMetabolic syndrome specific inclusion criteria\n\n1\\. Obesity defined as either\n\n1. BMI \\>30 kg\u002Fm\\^2 (or \\>=27 kg\u002Fm\\^2 in participants of Asian descent), OR\n2. Elevated waist circumference as defined below:\n\n   * Country\u002FEthnic group - Europid, Sub-Saharan African, Eastern Mediterranean and Middle East (Arab):\n\n     --Sex: Male - Waist circumference: \\>=94cm\n\n     --Sex: Female - Waist circumference: \\>=80cm\n   * Country\u002FEthnic group - South Asian, Chinese, Japanese, Ethnic South and Central American:\n\n     * Sex: Male - Waist circumference: \\>=90cm\n     * Sex: Female - Waist circumference: \\>=80cm\n\n       2\\. Elevated triglycerides defined as EITHER\n\n       2a. Fasting triglycerides \\>= 150 mg\u002FdL at screening, OR\n\n       2b. Specific treatment for hypertriglyceridemia\n\n       3\\. Low HDL cholesterol, defined as EITHER\n\n       3a. HDL \\\u003C40 mg\u002FdL (males) or \\\u003C50 mg\u002FdL (females) at screening, OR\n\n       3b. Specific treatment for low HDL\n\n       4\\. Elevated blood pressure defined as EITHER\n\n       4a. Systolic BP \\>= 130 at screening, OR\n\n       4b. Diastolic BP \\>= 85 mm Hg at screening, OR\n\n       4c. Treatment of previously diagnosed hypertension\n\n       5\\. Elevated glucose defined as EITHER\n\n       5a. HbA1c \\>= 5.7% (at screening), OR\n\n       5b. Fasting serum glucose \\>= 100 mg\u002FdL (at screening), OR\n\n       5c. 2-hour post-load glucose levels \\>= 140 mg\u002FdL (by history), OR\n\n       5d. Prior diagnosis of type 2 diabetes\n\n   Lipodystrophy-specific inclusion criteria:\n   1. Clinical diagnosis of generalized or partial lipodystrophy based on reduction in adipose tissue outside the normal range in some or all adipose depots (including, at aminimum, the gluteofemoral depot).\n   2. Insulin resistance as defined by fasting insulin \\>22.5 or high exogenous insulin requirement (\\> 2 units per kg per day or \\> 200 units total per day) at screening.\n\n   Nephrotic syndrome specific inclusion criteria\n   1. History of biopsy proven non-diabetic glomerular disease (any histology)\n   2. Nephrotic range proteinuria defined by ANY of the following:\n\n   2a. Protein\u002Fcreatinine ratio uPCR \\>= 3.5 g\u002Fg at screening, OR\n\n   2b. 24 hour protein excretion \\>= 3.5 gr\u002F24hr) at screening, OR\n\n   2c. History of nephrotic range proteinuria (as defined above) within the past 5 years but in complete (defined as proteinuria \\\u003C= 0.3 g\u002Fday or partial remission (defined as a 50% or greater decrease in proteinuria compared to baseline and proteinuria \\\u003C 3.5 g\u002Fday) based on 24 hr urine or uPCR at time of screening\n\n   EXCLUSION CRITERIA:\n\n   Common exclusion criteria (all groups):\n\n   An individual who meets any of the following criteria will be excluded from participation in this study:\n   1. Consuming extreme macronutrient diet (e.g., very low-carbohydrate, high fat diets such as ketogenic, paleo or Atkins diets, among others).\n   2. Plans to actively gain or lose weight during the study period (other than changes in water balance as clinically needed in subjects with nephrotic syndrome).\n   3. Change in body weight of \\>5% or \\>3 kg (whichever is larger) in the 3 months prior to screening (by participant report) in participants who do NOT have nephrotic syndrome.\n   4. Body weight \\>450 lbs (upper limit that can be accommodated by DXA scanner).\n   5. Participating in a regular strenuous exercise program (\\> 2h\u002Fweek of vigorous activity) as determined by volunteer report or evidence of vigorous exercising in order to lose weight, change body shape, or to counteract the effects of eating.\n   6. Uncontrolled diabetes, defined as HbA1c \\>9% at screening.\n   7. Lipemia defined as fasting or non-fasting triglycerides of \\>1000 mg\u002FdL at screening.\n   8. Renal dysfunction defined as eGFR \\\u003C50 mL\u002Fmin\u002F1.73 m\\^2 at screening.\n   9. In participants with liver disease, history of decompensated advanced liver disease, defined as direct bilirubin \\> 0.5 g\u002FdL, PT \\> 18 seconds, albumin \\\u003C 3 g\u002FdL, MELD score \\> 12, or history of ascites, encephalopathy, variceal bleeding, spontaneous bacterial\n\n      peritonitis or liver transplant.\n   10. History of hypertriglyceridemia-induced pancreatitis within 3 months prior to screening.\n   11. Positive pregnancy test or breastfeeding at screening.\n   12. Clinically significant abnormalities in thyroid function, blood counts, as assessed by screening labs.\n   13. Acute cardiovascular events within the past 6 months\n   14. Anemia (Hgb \\\u003C10 mg\u002FdL in women or \\\u003C12 mg\u002FdL in men) at screening\n   15. Food allergies or other dietary restrictions that could increase risk associated with test meals or cause the subject to be unwilling to consume test meals (i.e. celiac disease, vegan diets).\n   16. Subjects with chronic diarrhea, gastric bypass or lap-band procedures, ostomies, bowel motility problems, or other known conditions that could affect intestinal fat absorption.\n   17. Subjects treated with tamoxifen, estrogens, or progestins that have not been stable for \\>4 weeks prior to screening.\n   18. Blood donation in the last 2 weeks or planned blood donation during the study\n   19. Subjects requiring regular transfusions for any reason.\n   20. Subjects with known gastroparesis\n   21. Inability to adhere to Lifestyle Considerations throughout study duration.\n   22. Inability of the subject to understand and the unwillingness to sign a written informed consent document.\n   23. Unwillingness to comply with all study procedures and unavailable for the duration of the study\n   24. Any other condition or medication which, in the opinion of the investigator, increases risk to the subject, prevents the subject from complying with study procedures, prevents the subject from completing the study, or interferes with the interpretation of study results.","ALL","18 Years","120 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Background:\n\nAbnormal fats in the blood can lead to many problems, including heart disease. Researchers want to learn more about how eating meals with different levels of nutrients affects fats in the blood. Specifically, they want to study people with too much body fat, too little body fat, and a kidney problem called nephrotic syndrome.\n\nObjective:\n\nTo learn more about how different types of foods affect fat levels in the blood.\n\nEligibility:\n\nPeople aged 18 years or older with a health condition that affects how their body handles fats. Healthy volunteers are also needed.\n\nDesign:\n\nParticipants will have 2 overnight stays in the clinic within 6 months. At each visit, after staying overnight, they will eat a breakfast casserole. At 1 visit, breakfast will be a high-fat, low carbohydrate meal. At the other, it will be a high-carbohydrate, low-fat meal.\n\nParticipants will have a tube inserted into a vein in their arm. They will have blood drawn via the tube 12 times in 8 hours: 2 times before they eat the breakfast and 10 times after.\n\nParticipants will have other tests during their stays:\n\n* A resting metabolic test captures the air they exhale and measures how much energy they use at rest.\n* A dual energy X-ray absorptiometry (DXA) scan measures how much fat and muscle they have.\n* A Fibroscan is a special type of ultrasound of the liver.\n* A body surface scan uses lasers to measure the total area of the body.\n* A bioelectric impedance (BIS) exam measures how fast small electric currents move through their body.\n\nParticipants may opt to have a third visit. At this visit, the breakfast will be high in protein....",[26,27,28,29,30,31],"Nephrotic Syndrome","Lipodystrophy","Metabolic Syndrome","Healthy Volunteer","Diabetes","Metabolic Associated Steatotic Liver Disease",[33,34,35,36,37],"postprandial lipids","macronutrient","CARBOHYDRATES","FATS","Proteins","NOT_YET_RECRUITING","2026-07-10",{"date":41,"type":42},"2026-07-13","ACTUAL",{"date":44,"type":20},"2026-07-16",{"date":46,"type":20},"2031-08-01",{"name":48,"class":49},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",1,{"id":52,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":24,"conditions":55,"keywords":56,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":63,"locationsCount":50},"100617066",{"count":19,"type":20},[23],[26,27,28,29,30,31],[33,34,35,36,37],"2026-07-01",{"date":59,"type":42},"2026-07-02",{"date":61,"type":20},"2026-07-07",{"date":46,"type":20},{"name":48,"class":49},{"id":65,"slug":4,"hasResults":10,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":50},"100629981","NCT07481734","Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)","A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Tesamorelin (GHRH Analog) for Reducing Hepatic Steatosis in Adults With Metabolic Associated Steatotic Liver Disease (MASLD)","TESA-LIVER","Inclusion Criteria:\n\n* Adults age 18 to 75 years, able to provide informed consent.\n* Evidence of hepatic steatosis consistent with MASLD\u002FNAFLD, defined as MRI-PDFF \\>=10% at screening (or equivalent imaging documentation if MRI-PDFF was performed within the prior 8 weeks).\n* Fibrosis risk compatible with non-cirrhotic disease (e.g., FibroScan liver stiffness below a prespecified threshold and no clinical evidence of portal hypertension).\n* Stable body weight (+\u002F-5%) for at least 3 months prior to screening.\n* If on diabetes, lipid-lowering, antihypertensive, or weight-loss medications, regimen is stable for at least 3 months prior to screening and expected to remain stable through week 52.\n* Willingness and ability to self-administer daily subcutaneous injections (or have a trained caregiver).\n* For participants of childbearing potential: agreement to use reliable contraception during treatment and for 30 days after the last dose; negative pregnancy test at screening and baseline.\n\nExclusion Criteria:\n\n* Significant alcohol consumption consistent with alcohol-associated liver disease (e.g., \\>20 g\u002Fday for women or \\>30 g\u002Fday for men for sustained periods).\n* Other chronic liver diseases (e.g., chronic hepatitis B, chronic hepatitis C with viremia, autoimmune hepatitis, Wilson disease, hemochromatosis, alpha-1 antitrypsin deficiency).\n* Known cirrhosis or decompensated liver disease; or biopsy-proven stage 4 fibrosis if baseline biopsy is performed.\n* Poorly controlled diabetes or conditions increasing ocular risk (e.g., HbA1c at or above a protocol threshold; active\u002Funtreated diabetic retinopathy).\n* Use of exogenous growth hormone or GHRH analogs within the past 12 months.\n* Chronic systemic corticosteroids or chronic use of medications known to induce or worsen steatosis or liver injury (e.g., amiodarone, tamoxifen, methotrexate).\n* Active malignancy or high risk for recurrence judged unsafe by investigators.\n* Contraindications to MRI (e.g., certain implanted devices) if MRI-PDFF is required.\n* Pregnancy or breastfeeding.\n* Known hypersensitivity to tesamorelin or formulation excipients (e.g., mannitol).\n* Bariatric surgery within the last 12 months, or planned bariatric surgery during the study period.","75 Years",{"count":73,"type":20},120,[23],"This randomized, double-blind, placebo-controlled Phase II study evaluates whether daily subcutaneous tesamorelin (a growth hormone-releasing hormone analog) reduces liver fat in adults with fatty liver disease. Participants receive tesamorelin or matching placebo for 52 weeks, with standardized lifestyle counseling in both groups. Liver fat is quantified by MRI-proton density fat fraction (MRI-PDFF). Key safety monitoring includes glucose metrics and IGF-1.",[31,77,78],"Nonalcoholic Steatohepatitis","Hepatic Steatosis",[80,81,82,83,84,85,86,87],"Tesamorelin","GHRH analog","growth hormone axis","hepatic fat fraction","MRI-PDFF","transient elastography","teatohepatitis","fibrosis","RECRUITING","2026-03-14",{"date":91,"type":42},"2026-03-19",{"date":93,"type":42},"2026-02-02",{"date":95,"type":20},"2028-02-17",{"name":97,"class":98},"Hudson Biotech","INDUSTRY",{"id":100,"slug":4,"hasResults":10,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":71,"enrollmentInfo":106,"targetDuration":4,"studyType":108,"phases":4,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":5},"100602376","NCT07122700","Evaluation of Non-Invasive Tests for Metabolic Liver Disease","Non-Invasive Biomarkers for Metabolic Liver Disease (NIMBLE) Study 2.0 - An FNIH Biomarkers Consortium Study","NIMBLE","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged \\> 18 years and \\\u003C 75 years\n4. Participants must exhibit some manifestations of metabolic dysregulation. Either:\n\nA. Physician-diagnosed T2DM for at least 90 days with HbA1c \\> 6.5 and antidiabetic therapy, if any, stable for at least 90 days prior to screening or B. At least any one of the following six metabolic syndrome criteria \\[6\\]\n\n1\\. body mass index (BMI) of \\> 25 kg\u002Fm2 2. waist circumference: i. \\> 102 cm for men ii. \\> 88.9 cm for women 3. fasting triglyceride concentration \\> 150 mg\u002FdL i. or ongoing treatment with triglyceride lowering medication 4. HDL-cholesterol concentration: i. \\\u003C 40 mg\u002FdL for men ii. \\\u003C 50 mg\u002FdL for women iii. or ongoing treatment with cholesterol lowering medication. 5. fasting glucose concentration \\> 100 mg\u002FdL 6. either semi-recumbent or supine blood pressure systolic \\> 130 mmHg and\u002F or diastolic \\> 85 mmHg i. or ongoing treatment with antihypertensive medication. 5. FIB-4 \\> 1.3 (age \\\u003C 65 years) and \\> 2.0 (age \\> 65 years) 6. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration\n\nExclusion Criteria:\n\n1. Known history or evidence of other forms of chronic liver disease other than MASLD\u002FMASH including but not limited to viral hepatitis B or C, autoimmune liver disease, primary biliary cholangitis, primary sclerosing cholangitis, Wilson disease, hemochromatosis, drug-induced liver disease, conditions involving bile duct obstructions, liver cancer, past history of HCC or HCC treatment, listed for or history of liver transplantation, prior resection of liver, etc.\n2. Current or past evidence of decompensated liver disease defined by overt ascites that is clinically obvious and requires diuretic therapy, overt encephalopathy requiring therapy or history of variceal hemorrhage\n3. Circulating Alanine aminotransferase (ALT)\\> 5xULN\n4. Ongoing or recent (within the last two years prior to screening) consumption of significantly greater than moderate amounts of alcohol.\n\n   * A standard alcoholic drink is any drink that contains about 14 g of pure alcohol, such as 12 fluid ounces of regular beer 8-10 fluid ounces of malt liquor or flavored malt beverages such as hard seltzer 5 fluid ounces of table wine 3-4 fluid ounces of fortified wine such as sherry or port 2-3 fluid ounces of cordial liqueur or aperitif 1.5 fluid ounces (a single jigger or shot) of brandy, cognac, or distilled spirits such as gin, rum, tequila, vodka, whiskey, etc.\n   * Significantly greater than moderate alcohol consumption is defined as on average over a 2-year period prior to screening:\n\n   Women\n   * \\>1 standard drink per day and\u002For\n   * \\>14 standard drinks per week Men\n   * \\>2 standard drinks per day and\u002For\n   * \\>21 standard drinks per week in men\n\n     * An Alcohol Use Disorders Identification Test (AUDIT) score of 7 or higher\n     * A PEth test score of ≥ 20ng\u002Fml.\n5. In the opinion of the investigator, any contraindications to liver biopsy including but not limited to having significant uncorrected coagulopathy or thrombocytopenia, on chronic anticoagulation with Direct Oral Anticoagulants (DOACs), or on low dose heparin or Warfarin.\n6. Uncontrolled systolic blood pressure \\> 180 mmHg and diastolic blood pressure \\> 120 mmHg at screening. Blood pressure will be obtained after at least 10 minutes of resting in a semi-recumbent or supine position.\n7. Any systemic disease that in the opinion of the investigator precludes inclusion of the patient in the trial\n8. Unable or unwilling to provide informed consent\n9. Unwilling to undergo liver biopsy procedure\n10. Unable or unwilling to comply with requirements for study procedures (such as fasting)\n11. Unable to perform study procedures in the opinion of the investigator\n12. Participants who are unwilling or unable (e.g. due active implants such as pacemaker or having a waist diameter (calculated as: diameter = circumference \u002F π) 70cm, unless a wide-bore MRI machine is available) to undergo MRI procedures.\n13. Pregnancy or planned pregnancy within 4 months of screening.\n14. Participation in another clinical trial within 30 days, or dosing with an investigational agent within 90 days prior to signing the ICF for this study.",{"count":107,"type":20},400,"OBSERVATIONAL","The Non-Invasive Biomarkers for Metabolic Liver Disease (NIMBLE) study is a comprehensive, multi-year collaborative effort to standardize, validate and advance the regulatory qualification of blood- and imaging-based biomarkers to diagnose and stage Metabolic dysfunction-associated steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH). MASH is characterized by liver inflammation accompanied by simultaneous fat accumulation in the liver.",[111,31,112,113,114,115,116,117],"Metabolic Associated Fatty Liver Disease","Cirrhosis, Liver","NASH","Liver Fibrosis","Liver Fat","Liver Steatoses","Liver Inflammation","2025-08-07",{"date":120,"type":42},"2025-08-14",{"date":122,"type":42},"2025-05-13",{"date":124,"type":20},"2026-07-31",{"name":126,"class":127},"Foundation for the National Institutes of Health","OTHER",""]