Opening soonNot applicableInterventional
What this study is about
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).
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionType 2 Diabetes, Obesity, Non-alcoholic Fatty Liver Disease
Full registry criteria
Inclusion Criteria: * 1\. Age≥18 and ≤65 years, male or female. * 2\. MRI-PDFF ≥10% within 3 months prior to randomized. * 3\. Diagnosis of T2DM. * 4\. HbA1c: 7.0%-10.5%. * 5\. FPG: 7.0-13.3 mmol/L. * 6\. BMI: 30-45 kg/m2. * 7\. Subjects control blood glucose only by lifestyle intervention for at least 3 months before the screening period. * 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. * 9\. Can understand the research content, follow the research protocol, and voluntarily sign the ICF. Exclusion Criteria: * 1\. ALT≥2.5×ULN, AST≥2.5×ULN, TBil≥2×ULN, creatinine (Cr) ≥1.5×ULN and Serum creatinine clearance\<60 mL/min, PLT\<100×10\^9/L, INR \>1.3, ALB \<3.5 g/dL. * 2\. Use of glucose-lowering medication in the 3 months prior to randomization. * 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. * 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. * 5\. Subjects with T1DM, monogenic diabetes, diabetes caused by pancreatic damage, or other secondary diabetes. * 6\. Subjects with a history of severe pruritus. * 7\. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. * 8\. Thyroid C-cell tumour or family history, multiple endocrine neoplasia type 2 or family history. * 9\. History of acute or chronic pancreatitis. * 10\. Subjects with Child-Pugh class B or C grade cirrhosis. * 11\. HBsAg positive, HCV Ab positive, HIV Ab positive, TP Ab positive. * 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. * 13\. Diseases that interfere with the absorption, distribution, metabolism or excretion. * 14\. Gastrointestinal diseases that affect food digestion and absorption. * 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. * 16\. History of malignant tumors within the first 5 years of randomization. * 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. * 18\. Drug abuse or alcohol abuse within the first 6 months of randomization. * 19\. Poor blood pressure control. * 20\. Mental illness, epilepsy. * 21\. Patients with uncontrollable severe infectious diseases before randomization. * 22\. Pregnant, planned pregnancy or breastfeeding. * 23\. Participated in other clinical trials in the first three months of randomization. * 24\. Any condition that in the judgement of the researcher precludes participation.
Treatments and study arms
CS0159
Drug
The intervention will include a 12-week treatment period. During the 12-week treatment period, subjects will receive 4mg CS0159 (oral, once daily).
CS0159 placebo
Drug
The intervention will include a 12-week treatment period. During the 12-week treatment period, subjects will receive CS0159 placebo (oral, once daily).
Semaglutide
Drug
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).
Study locations
0 locations were listed when this page was built. The first 40 are shown.
No public site location was included in this record. Check the original registry for updates.