Not yet recruitingPhase NA

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

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

Study population

MASH / NAFLD / liver fibrosis, Obesity / overweight, Type 2 diabetes

Eligibility highlights

•BMI 30-45•HbA1c 7-10.5%

Primary endpoints

•Body weight, % change•Changes in energy expenditure

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07570810

Org study IDMAFLD-CS0159-IIT-E

Timeline

Milestones

Study first posted2026-05-06actual

Last update posted2026-05-06actual

Study start2026-06-01estimated

Primary completion2026-11-30estimated

Study completion2026-12-31estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

MASH / NAFLD / liver fibrosisObesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (17)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Other (unclassified)

Glycemic / diabetes

MASH / liver

Cardiometabolic biomarkers

Safety / tolerability / PK

Weight & body composition

6 endpoints

Primary/protocol endpoint

Percentage change in body weight relative to baseline

Time frame:Baseline to 12 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in patient's weight relative to the baseline

Time frame:Baseline to 12 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Changes relative to baseline in BMI

Time frame:Baseline to 12 weeks

BMI, change

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Changes relative to baseline in body composition

Time frame:Baseline to 12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Changes relative to baseline in waist circumference

Time frame:Baseline to 12 weeks

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Changes relative to baseline in waist to hip ratio (WHR)

Time frame:Baseline to 12 weeks

change from baseline, improvement

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Percentage change in HbA1c relative to baseline

Time frame:Baseline to 12 weeks

HbA1c, % change

percent change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Changes relative to baseline in plasma glucose levels

Time frame:Baseline to 12 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Changes relative to baseline in serum insulin levels

Time frame:Baseline to 12 weeks

change from baseline, improvement

MASH / liver

1 endpoint

Secondary/protocol endpoint

Changes relative to baseline in serum liver function parameters

Time frame:Baseline to 12 weeks

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Changes relative to baseline in serum lipid profile

Time frame:Baseline to 12 weeks

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Time frame:Baseline to 12 weeks

Treatment-emergent AEs (any)

event count, event

Other (unclassified)

5 endpoints

Primary/protocol endpoint/low confidence

Changes in energy expenditure

Time frame:Baseline to 12 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in patient's glucose oxidation

Time frame:Baseline to 12 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in patient's lipid oxidation

Time frame:Baseline to 12 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Changes in peripheral blood metabolomics and proteomics relative to baseline

Time frame:Baseline to 12 weeks

descriptive

Secondary/protocol endpoint/low confidence

Changes in fecal metabolites, gut microbiota homeostasis, and fecal gut microbiota metagenome relative to baseline

Time frame:Baseline to 12 weeks

change from baseline, descriptive

componentsfecal metabolites change, gut microbiota homeostasis change, fecal microbiota metagenome change

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.