Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MAFLD Patients With Obesity and T2DM
- Status
- Not yet recruitingResults none
- Why it is watched
- non-weight indication: liver, addiction
- Who it enrolls
- age 18 Years to 65 Years; no BMI minimum stated; conditions: Type 2 Diabetes; Obesity; Non-alcoholic Fatty Liver Disease
- Interventions
- CS0159; CS0159 placebo; Semaglutide
- Conditions
- Type 2 Diabetes; Obesity; Non-alcoholic Fatty Liver Disease
- Phase and size
- NA · 30 participants
- Dates
- Start 2026-06-01
Primary completion 2026-11-30 - Sponsor
- Shanghai Jiao Tong University School of Medicine (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Percentage change in body weight relative to baselineBaseline to 12 weeks
- Changes in energy expenditureBaseline to 12 weeks
02Eligibility
Who can take part
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.
03Change log
Registry changes
No changes recorded since the trial was added.