Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MAFLD Patients With Obe… (NCT07570810) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MAFLD Patients With Obesity and T2DM
30 participantsStarted 2026-06-01
Plain-language summary
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).
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Percentage change in body weight relative to baseline
Timeframe: Baseline to 12 weeks
2
Changes in energy expenditure
Timeframe: Baseline to 12 weeks
Trial details
NCT IDNCT07570810
SponsorShanghai Jiao Tong University School of Medicine