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

NCT ID: NCT06492330

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-19
• Study Completion Date: 2025-04-22

Brief Summary

This is an exploratory study evaluating CS0159 in combination with Semaglutide in MASH patients with obesity and T2DM.

Detailed Description

This is an exploratory study to evaluate the efficacy, safety, and tolerability of CS0159 in combination with Semaglutide in MASH patients with obesity and T2DM. A total of 60 patients will be recruited. BMI ≥35 kg/m2 will be used as a randomized stratification factor, and patients will be randomly assigned in a 1:1 ratio.

Conditions

Metabolic Dysfunction-Associated Steatohepatitis (MASH); Obesity; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

4mg CS0159

4mg CS0159 (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly) for 16 weeks

Group Type: ACTIVE_COMPARATOR

CS0159

Intervention Type: DRUG

The intervention will include a 2-week screening period, a 16-week treatment period, and a 4-week follow-up period. Efficacy and safety evaluations will be conducted after the end of the treatment. During the 16-week treatment period, subjects will receive 4mg CS0159 (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly).

CS0159 Placebo

CS0159 placebo (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly) for 16 weeks

Group Type: PLACEBO_COMPARATOR

CS0159 placebo

Intervention Type: DRUG

The intervention will include a 2-week screening period, a 16-week treatment period, and a 4-week follow-up period. Efficacy and safety evaluations will be conducted after the end of the treatment. During the 16-week treatment period, subjects will receive CS0159 placebo (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly).

Interventions

CS0159

The intervention will include a 2-week screening period, a 16-week treatment period, and a 4-week follow-up period. Efficacy and safety evaluations will be conducted after the end of the treatment. During the 16-week treatment period, subjects will receive 4mg CS0159 (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly).

Intervention Type: DRUG

CS0159 placebo

The intervention will include a 2-week screening period, a 16-week treatment period, and a 4-week follow-up period. Efficacy and safety evaluations will be conducted after the end of the treatment. During the 16-week treatment period, subjects will receive CS0159 placebo (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly).

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Wang Weiqing

Professor, PHD, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dep.endocrinology of Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

MASH-CS0159-IIT

Identifier Type: -

Identifier Source: org_study_id