[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nash-with-fibrosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nash-with-fibrosis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,96],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100532662","phase-3-a-study-evaluating-efruxifermin-in-subjects-with-non-cirrhotic-nonalcoholic-steatohepatitis-nashmetabolic-dysfunction-associated-steatohepatitis-mash-and-fibrosis-100532662",false,"NCT06215716","A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)\u002FMetabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)\u002FMetabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis","Inclusion Criteria:\n\n* Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit.\n* Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes.\n* Cohort 1: Biopsy-proven NASH\u002FMASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:\n\n  * Steatosis (scored 0 to 3),\n  * Ballooning degeneration (scored 0 to 2), and\n  * Lobular inflammation (scored 0 to 3).\n* Cohort 2: Biopsy-proven fibrosis stage 3. Must have had a liver biopsy obtained ≤ 180 days prior to screening. Subjects with NAS \\\u003C4 may be enrolled and are not required to meet 1 point in each of the components of NAS.\n\nExclusion Criteria:\n\n* Other causes of liver disease based on medical history and\u002For liver histology and\u002For central laboratory results.\n* Presence of cirrhosis on liver biopsy (fibrosis stage 4).\n* Type 1 or uncontrolled Type 2 diabetes.\n\nOther inclusion and exclusion criteria may apply.","ALL","18 Years","80 Years",{"count":20,"type":21},1650,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH\u002FMASH and fibrosis stage 2 or 3 (F2 or F3).\n\nThe study will enroll subjects in two cohorts for a total samples size of 1650 subjects.",[27,28],"NASH With Fibrosis","MASH With Fibrosis","RECRUITING","2026-06-23",{"date":32,"type":33},"2026-06-25","ACTUAL",{"date":35,"type":33},"2023-12-01",{"date":37,"type":21},"2033-02",{"name":39,"class":40},"Akero Therapeutics, Inc","INDUSTRY",356,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":73,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":95},"100526751","effect-of-endoscopic-sleeve-gastroplasty-in-patients-with-obesity-and-mash-a-randomized-controlled-trial-100526751","NCT06138821","Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled Trial","Effect of Endoscopic Sleeve Gastroplasty on Patients With Obesity and Concomitant Metabolic Dysfunction-Associated Steatohepatitis (MASH): A Multicenter, Open-label, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age ≥ 18 (male or female)\n2. BMI ≥30 kg\u002Fm2 or ≥27 kg\u002Fm2 with at least one obesity-related comorbidity\n3. Self-reported stable weight (no weight change \\>5%) for 6 months prior to the first study visit\n4. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory\u002Fimaging\u002Fadditional tests, and completing diet counseling\n5. Willingness to NOT start a new anti-obesity medication for the following 12 months\n6. Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete routine follow-up visits\n7. Ability to give informed consent\n8. Women of childbearing potential (i.e., not post-menopausal, nor surgically sterilized) must agree to use adequate birth control methods\n\nExclusion Criteria:\n\n1. Known history of other chronic liver diseases (viral hepatitis, autoimmune hepatitis, drug-induced hepatitis, and genetic)\n2. Treatment with vitamin E (at doses ≥800 IU\u002Fday), pioglitazone, obeticholic acid, or resmetirom \\\u003C90 days before the first study visit\n3. History of foregut or gastrointestinal (GI) surgery (except uncomplicated fundoplication, cholecystectomy or appendectomy)\n4. Prior bariatric surgery\n5. Prior endoscopic sleeve gastroplasty\n6. Any inflammatory disease of the GI tract, including severe (LA Grade C or D) esophagitis, Barrett's esophagus with dysplasia, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease\n7. Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses\n8. Severe gastroesophageal reflux disease (GERD)\n9. A structural abnormality in the esophagus or pharynx, such as a stricture or diverticulum, that could impede passage of the endoscope.\n10. Achalasia or any other severe esophageal motility disorder\n11. Chronic abdominal pain\n12. Gastroparesis or intractable constipation\n13. Hepatic insufficiency or cirrhosis\n14. Severe coagulopathy\n15. Insulin-dependent diabetes (either type 1 or type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or HgbA1C ≥ 12%\n16. Patients on an anti-platelet agent, anticoagulant agent or chronic\u002Froutine use of NSAIDs\n17. Patients on corticosteroids, immunosuppressants, or narcotics\n18. Patients on an anti-seizure or anti-arrhythmic medication\n19. Patients who are pregnant or breastfeeding\n20. Excessive alcohol consumption (\\>20 g per day for women; \\>30 g per day for men)\n21. Active smoking\n22. History of poorly controlled hypertension, coronary artery disease, congestive heart failure, cardiac arrhythmia\n23. History of respiratory diseases such as chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia, or cancer\n24. History of autoimmune connective tissue disorder such as lupus, scleroderma or immunocompromised disease\n25. History of active malignancy\n26. History of genetic or hormonal causes for obesity, such as Prader Willi syndrome\n27. History of endocrine disorders affecting weight, such as uncontrolled hypothyroidism\n28. Eating disorders, including night eating syndrome, bulimia, binge eating disorder or compulsive overeating\n29. Active psychological issues preventing participation in a lifestyle modification program as determined by a psychologist",{"count":50,"type":21},132,[52],"NA","Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease globally. While weight loss through lifestyle modification is the standard treatment, most patients regain weight limiting ultimate improvement in liver disease. On the other end of the spectrum, bariatric surgery has shown promise in the treatment of MASLD\u002Fmetabolic dysfunction-associated steatohepatitis (MASH) due to its efficacy in inducing weight loss. Nevertheless, its adoption has been hindered by the perceived invasiveness of surgery.\n\nOver the past decade, endoscopic sleeve gastroplasty (ESG) has gained recognition as a promising minimally-invasive approach to weight loss. The procedure involves utilizing a Food and Drug Administration (FDA)-authorized endoscopic suturing device to reduce the gastric volume by 70%. Studies reveal that ESG is associated with approximately 18.2% weight loss at one year after the procedure, with sustained results for at least 10 years. Nevertheless, the effect of ESG on MASH remains unknown.\n\nIn this study, the investigators will compare ESG + lifestyle modification versus lifestyle modification alone in treating histologic MASH. The study will randomize patients to one of two different treatment options: ESG + lifestyle modification or lifestyle modification alone.",[55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,27,70,71,72],"Obesity","Liver Diseases","Liver Fibrosis","Liver Fat","Metabolic Dysfunction-Associated Steatotic Liver Disease","Metabolic Dysfunction-Associated Steatohepatitis","MASLD","MASH","Weight Loss","Insulin Resistance","Insulin Sensitivity","Insulin Sensitivity\u002FResistance","Metabolic Disease","Diabetes","Diabetes Mellitus, Type 2","Non-Alcoholic Fatty Liver Disease","Non Alcoholic Fatty Liver","Non-alcoholic Steatohepatitis",[74,75,76,77,78,79,80,81,82,83,84,85,86],"Gut Hormones","Endoscopic Bariatric and Metabolic Therapy (EBMT)","Intragastric Balloon (IGB)","Endoscopic Suturing","Endoscopic Sleeve Gastroplasty (ESG)","Weight Management","Endoscopic Gastric Remodeling (EGR)","Endoscopic Bariatric Therapy (EBT)","Fatty Liver","Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Non-Alcoholic Fatty Liver Disease (NAFLD)","Non-Alcoholic Steatohepatitis (NASH)",{"date":32,"type":33},{"date":89,"type":33},"2025-06-24",{"date":91,"type":21},"2028-06",{"name":93,"class":94},"Pichamol Jirapinyo, MD, MPH","OTHER",2,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":108,"conditions":109,"keywords":112,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100390674","effectiveness-of-bariatric-surgery-for-nafldnash-100390674","NCT04366999","Effectiveness of Bariatric Surgery for NAFLD\u002FNASH","Effectiveness of Bariatric Surgery for Nonalcoholic Fatty Liver Diseases\u002FNonalcoholic Steatohepatitis With Fibrosis : A Prospective, Multicentric Cohort Study","Inclusion Criteria:\n\n\\[For Base-NAFLD\\]\n\n1. Age between 16 and 65 years (all sexes).\n2. Diagnosed with obesity according to the World Health Organization criteria for obesity in Asian populations and scheduled for a primary bariatric surgery at the participating centres.\n3. Diagnosed with hepatic steatosis preoperatively by radiologic (including ultrasonography, magnetic resonance imaging \\[MRI\\]-derived proton density fat fraction \\[PDFF\\]) or pathologic(intraoperative hepatic pathology) examinations.\n\n\\[For Base-NASH\\]\n\n1. Age between 16 and 65 years (all sexes).\n2. Diagnosed with obesity according to the World Health Organization criteria for obesity in Asian populations and scheduled for a primary bariatric surgery at the participating centres.\n3. Histologically confirmed NASH with fibrosis:\n\nNAFLD activity score(NAS) ≥4 with at least 1 in each single item and NASH-CRN fibrosis stage ≥F1\n\nExclusion Criteria:\n\n* any patient who had previously been submitted to any type of bariatric surgery;\n* history of excessive drinking: in the past 12 months, the male equivalent of alcohol consumption more than 30g\u002Fd, and the female more than 20g\u002Fd;\n* history of taking amiodarone, methotrexate, tamoxifen, glucocorticoids, etc.；\n* history of specific diseases: Gene type 3 hepatitis C virus (HCV) infection, hepatolenticular degeneration, autoimmune hepatitis, total parenteral nutrition, lack of beta lipoproteinemia, congenital lipid atrophy, celiac disease which causing fatty liver, etc.;\n* previous major gastrointestinal surgery；\n* diagnosed or suspected malignancy；\n* poorly controlled significant medical or psychiatric disorders；\n* disorders such as a medical history of major pathology;\n* can not be able to understand and willing to participate in this registry with signature.","16 Years","65 Years",{"count":106,"type":21},320,"OBSERVATIONAL","This is a prospective, multicenter cohort study, which subjects were obese patients requiring bariatric surgery.\n\nThis study aims to explore the the effectiveness of bariatric surgery for NAFLD\u002FNASH with fribrosis, to explore the differences in the effectiveness among sleeve gastrostomy \\[SG\\], Roux-en-Y gastric bypass \\[RYGB\\], or one anastomosis gastric bypass \\[OAGB\\], and to explore the independent effectiveness of bariatric surgery in histological remission of NAFLD\u002FNASH.\n\nThe first stage of the cohort was started in 2020, named Base-NAFLD; In May 2024, based on Base-NAFLD, we plan to continue established a secondary cohort, named Base-NASH.",[110,111,27],"Bariatric Surgery Candidate","NAFLD",[113,111,114,115,55],"Bariatric surgery","NASH","Fibrosis","2024-05-10",{"date":118,"type":33},"2024-05-14",{"date":120,"type":33},"2020-04-21",{"date":122,"type":21},"2026-12-31",{"name":124,"class":94},"Beijing Friendship Hospital",1]