CompletedPhase NA

Efficacy and Safety of CS0159 Combined With Semaglutide in MASH Patients With Obesity and T2DM

A Multi-center, Randomized, Double-blind, Placebo-controlled Proof of Concept Study Evaluating the Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MASH Patients With Obesity and T2DM

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

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

Eligibility highlights

•BMI 30-45•HbA1c 7-10.5%

Primary endpoint

•Body weight, % change

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 IDNCT06492330

Org study IDMASH-CS0159-IIT

Timeline

Milestones

Study first posted2024-07-09actual

Study start2024-07-19actual

Primary completion2025-02-28actual

Study completion2025-04-22actual

Last update posted2025-06-03actual

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. Patients with previous liver biopsy for MASH or MRI-PDFF ≥10% within 3 months prior to randomization.

•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.

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 (21)

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

Glycemic / diabetes

Weight & body composition

MASH / liver

Safety / tolerability / PK

Renal / kidney

Cardiometabolic biomarkers

Patient-reported / QoL

Weight & body composition

5 endpoints

Primary/protocol endpoint

Percentage change in body weight relative to baseline

Time frame:Baseline to 16 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Proportion of subjects achieving ≥5% weight loss

Time frame:Baseline to 16 weeks

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Changes relative to baseline in body mass index (BMI)

Time frame:Baseline to 16 weeks

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Changes relative to baseline in body composition

Time frame:Baseline to 16 weeks

percent change from baseline, improvement

Secondary/protocol endpoint

Changes relative to baseline in waist circumference and waist-to-hip ratio (WHR)

Time frame:Baseline to 16 weeks

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

7 endpoints

Secondary/protocol endpoint

Percentage change in HbA1c relative to baseline

Time frame:Baseline to 16 weeks

HbA1c, % change

percent change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Fasting plasma glucose levels

Time frame:Baseline to 16 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

2-hour post-prandial plasma glucose levels

Time frame:Baseline to 16 weeks

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Fasting serum insulin levels

Time frame:Baseline to 16 weeks

change from baseline, improvement

Secondary/protocol endpoint

2-hour post-prandial serum insulin levels

Time frame:Baseline to 16 weeks

change from baseline, improvement

Secondary/protocol endpoint

Fasting serum C peptide levels

Time frame:Baseline to 16 weeks

change from baseline, improvement

Secondary/protocol endpoint

2-hour post-prandial serum C peptide levels

Time frame:Baseline to 16 weeks

C-peptide AUC

change from baseline, improvement

MASH / liver

3 endpoints

Secondary/protocol endpoint

Percentage change in liver fat content relative to baseline

Time frame:Baseline to 16 weeks

Liver fat content, change

percent change from baseline, improvement

Secondary/protocol endpoint

Changes relative to baseline in liver function

Time frame:Baseline to 16 weeks

change from baseline, improvement

Secondary/protocol endpoint

Changes relative to baseline in parameters of hepatic fibrosis

Time frame:Baseline to 16 weeks

percent change from baseline, improvement

Renal / kidney

1 endpoint

Secondary/protocol endpoint/low confidence

Changes relative to baseline in renal function

Time frame:Baseline to 16 weeks

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Changes relative to baseline in lipid profile

Time frame:Baseline to 16 weeks

percent change from baseline, improvement

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Short form 36 health survey questionnaire (SF-36)

Time frame:Baseline to 16 weeks

SF-36 total

change from baseline, improvement

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

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

Time frame:Baseline to 16 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Patient Health Questionnaire 9 (PHQ-9)

Time frame:Baseline to 16 weeks

descriptive

Secondary/protocol endpoint

Visual analog scale for pruritus and 5-D itch scale

Time frame:Baseline to 16 weeks

change from baseline, descriptive

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.