[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636832":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":36,"locations":27,"responsibleParty":42,"collaborators":27,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":27,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":27,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":27,"overallStatus":67,"whyStopped":27,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":27},{"fullName":5,"class":6},"Shanghai Jiao Tong University School of Medicine","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"4mg CS0159","ACTIVE_COMPARATOR","4mg CS0159 (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly) for 12 weeks",[13,14],"Drug: CS0159","Drug: Semaglutide",{"label":16,"type":17,"description":18,"interventionNames":19},"CS0159 Placebo","PLACEBO_COMPARATOR","CS0159 placebo (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly) for 12 weeks",[20,14],"Drug: CS0159 placebo",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","CS0159","The intervention will include a 12-week treatment period. During the 12-week treatment period, subjects will receive 4mg CS0159 (oral, once daily).",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"CS0159 placebo","The intervention will include a 12-week treatment period. During the 12-week treatment period, subjects will receive CS0159 placebo (oral, once daily).",[16],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Semaglutide","The intervention will include a 12-week treatment period. During the 12-week treatment period, subjects will receive 0.5mg Semaglutide (subcutaneous injection, once weekly).",[9,16],[37],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},"Yifei Zhang","CONTACT","+86-13524640378","feifei-a@163.com",{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Wang Weiqing","Professor, PHD, MD","100636832","efficacy-safety-and-tolerability-of-cs0159-combined-with-semaglutide-in-mafld-patients-with-obesity-and-t2dm-100636832",false,"NCT07570810","Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MAFLD Patients With Obesity and T2DM","A Single -Center, Randomized, Double-blind, Placebo-controlled Proof of Exploratory Study Evaluating the Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MAFLD Patients With Obesity and T2DM","Inclusion Criteria:\n\n* 1\\. Age≥18 and ≤65 years, male or female.\n* 2\\. MRI-PDFF ≥10% within 3 months prior to randomized.\n* 3\\. Diagnosis of T2DM.\n* 4\\. HbA1c: 7.0%-10.5%.\n* 5\\. FPG: 7.0-13.3 mmol\u002FL.\n* 6\\. BMI: 30-45 kg\u002Fm2.\n* 7\\. Subjects control blood glucose only by lifestyle intervention for at least 3 months before the screening period.\n* 8\\. Willing to maintain consistent diet and exercise habits throughout the entire study, and adhere to the study protocol for timely administration of the study drug, and timely self-monitoring of blood glucose and recording.\n* 9\\. Can understand the research content, follow the research protocol, and voluntarily sign the ICF.\n\nExclusion Criteria:\n\n* 1\\. ALT≥2.5×ULN, AST≥2.5×ULN, TBil≥2×ULN, creatinine (Cr) ≥1.5×ULN and Serum creatinine clearance\\\u003C60 mL\u002Fmin, PLT\\\u003C100×10\\^9\u002FL, INR \\>1.3, ALB \\\u003C3.5 g\u002FdL.\n* 2\\. Use of glucose-lowering medication in the 3 months prior to randomization.\n* 3\\. Weight loss ≥ 5% in the 3 months prior to randomization or ≥10% in the 6 months prior to randomization or use of other weight-lowering drugs, corticosteroids, and etc.\n* 4\\. History of allergy to glucagon-like peptide-1 receptor agonists (GLP-1RA) medications, currently in an allergic state, having allergic conditions, or history of allergies to ≥2 substances.\n* 5\\. Subjects with T1DM, monogenic diabetes, diabetes caused by pancreatic damage, or other secondary diabetes.\n* 6\\. Subjects with a history of severe pruritus.\n* 7\\. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy.\n* 8\\. Thyroid C-cell tumour or family history, multiple endocrine neoplasia type 2 or family history.\n* 9\\. History of acute or chronic pancreatitis.\n* 10\\. Subjects with Child-Pugh class B or C grade cirrhosis.\n* 11\\. HBsAg positive, HCV Ab positive, HIV Ab positive, TP Ab positive.\n* 12\\. Arrhythmias, male QTc≥450 ms, or female QTc≥470 ms. Or cardiovascular disease for which the researcher has assessed that participation in the trial is not appropriate.\n* 13\\. Diseases that interfere with the absorption, distribution, metabolism or excretion.\n* 14\\. Gastrointestinal diseases that affect food digestion and absorption.\n* 15\\. Use moderate or strong inhibitors or inducers of cytochrome P450 enzyme (CYP3A4 enzyme) within the first 14 days of randomization and throughout the entire trial period.\n* 16\\. History of malignant tumors within the first 5 years of randomization.\n* 17\\. Serious hypoglycemic events occurring ≥ 3 times within 12 weeks prior to administration, or acute and severe metabolic disorder occurred within 12 weeks prior to administration.\n* 18\\. Drug abuse or alcohol abuse within the first 6 months of randomization.\n* 19\\. Poor blood pressure control.\n* 20\\. Mental illness, epilepsy.\n* 21\\. Patients with uncontrollable severe infectious diseases before randomization.\n* 22\\. Pregnant, planned pregnancy or breastfeeding.\n* 23\\. Participated in other clinical trials in the first three months of randomization.\n* 24\\. Any condition that in the judgement of the researcher precludes participation.","ALL","18 Years","65 Years",{"count":57,"type":58},30,"ESTIMATED","INTERVENTIONAL",[61],"NA","This is an exploratory study evaluating CS0159 in combination with Semaglutide in metabolic dysfunction-associated fatty liver disease (MAFLD) patients with obesity and type 2 diabetes (T2DM).",[64,65,66],"Type 2 Diabetes","Obesity","Non-alcoholic Fatty Liver Disease","NOT_YET_RECRUITING","2026-05-01",{"date":70,"type":71},"2026-05-06","ACTUAL",{"date":73,"type":58},"2026-06-01",{"date":75,"type":58},"2026-12-31",{"name":5,"class":6}]