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CompletedNCT06492330Updated Jun 3, 2025

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

An interventional study of CS0159 and CS0159 placebo in Metabolic Dysfunction-Associated Steatohepatitis (MASH), Obesity and Diabetes Mellitus, Type 2, sponsored by Shanghai Jiao Tong University School of Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-06-03.

Sponsored by Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Metabolic Dysfunction-Associated Steatohepatitis (MASH)
  • Obesity
  • Diabetes Mellitus, Type 2
03

In context

Fatty Liver

1,451 studies on the registry are indexed under Fatty Liver; 292 are open to participants now.

This study's enrollment of 62 is close to the median of 60 across 1,003 interventional studies indexed under Fatty Liver.

Browse Fatty Liver studies →

Lead sponsor

Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    1. Age≥18 and ≤65 years, male or female.
    1. Patients with previous liver biopsy for MASH or MRI-PDFF ≥10% within 3 months prior to randomization.
    1. Diagnosis of T2DM.
    1. HbA1c: 7.0%-10.5%.
    1. FPG: 7.0-13.3 mmol/L.
    1. BMI: 30-45 kg/m2.
    1. Subjects control blood glucose only by lifestyle intervention for at least 3 months before the screening period.
    1. 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

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.
    1. Use of glucose-lowering medication in the 3 months prior to randomization.
    1. 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.
    1. 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.
    1. Subjects with T1DM, monogenic diabetes, diabetes caused by pancreatic damage, or other secondary diabetes.
    1. Subjects with a history of severe pruritus.
    1. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
    1. Thyroid C-cell tumour or family history, multiple endocrine neoplasia type 2 or family history.
    1. History of acute or chronic pancreatitis.
    1. Subjects with Child-Pugh class B or C grade cirrhosis.
    1. HBsAg positive, HCV Ab positive, HIV Ab positive, TP Ab positive.
    1. 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.
    1. Diseases that interfere with the absorption, distribution, metabolism or excretion.
    1. Gastrointestinal diseases that affect food digestion and absorption.
    1. 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.
    1. History of malignant tumors within the first 5 years of randomization.
    1. 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.
    1. Drug abuse or alcohol abuse within the first 6 months of randomization.
    1. Poor blood pressure control.
    1. Mental illness, epilepsy.
    1. Patients with uncontrollable severe infectious diseases before randomization.
    1. Pregnant, planned pregnancy or breastfeeding.
    1. Participated in other clinical trials in the first three months of randomization.
    1. Any condition that in the judgement of the researcher precludes participation.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
62 participants (actual)

Study arms

  • Active comparator
    4mg CS0159

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

    Drug: CS0159

  • Placebo comparator
    CS0159 Placebo

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

    Drug: CS0159 placebo

Interventions

  • DrugCS0159

    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).

  • DrugCS0159 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).

06

What researchers measure

Primary outcomes

  1. Percentage change in body weight relative to baseline

    Evaluate the percentage change in body weight relative to baseline after 16 weeks of treatment.

    Time frame: Baseline to 16 weeks

Secondary outcomes

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

    Safety outcomes

    Time frame: Baseline to 16 weeks

  2. Patient Health Questionnaire 9 (PHQ-9)

    Safety outcomes

    Time frame: Baseline to 16 weeks

  3. Short form 36 health survey questionnaire (SF-36)

    Safety outcomes

    Time frame: Baseline to 16 weeks

  4. Visual analog scale for pruritus and 5-D itch scale

    Safety outcomes

    Time frame: Baseline to 16 weeks

  5. Proportion of subjects achieving ≥5% weight loss

    Proportion of subjects achieving ≥5% weight loss from baseline after 16 weeks of treatment.

    Time frame: Baseline to 16 weeks

  6. Percentage change in HbA1c relative to baseline

    Evaluate the percentage change in glycated hemoglobin (HbA1c) relative to baseline after 16 weeks of treatment.

    Time frame: Baseline to 16 weeks

  7. Fasting plasma glucose levels

    Changes in fasting plasma glucose levels relative to baseline after 16 weeks of treatment.

    Time frame: Baseline to 16 weeks

  8. 2-hour post-prandial plasma glucose levels

    Changes in 2-hour post-prandial plasma glucose levels relative to baseline after 16 weeks of treatment.

    Time frame: Baseline to 16 weeks

  9. Fasting serum insulin levels

    Changes in fasting serum insulin levels relative to baseline after 16 weeks of treatment.

    Time frame: Baseline to 16 weeks

  10. 2-hour post-prandial serum insulin levels

    Changes in 2-hour post-prandial serum insulin levels relative to baseline after 16 weeks of treatment.

    Time frame: Baseline to 16 weeks

  11. Fasting serum C peptide levels

    Changes in fasting serum C peptide levels relative to baseline after 16 weeks of treatment.

    Time frame: Baseline to 16 weeks

  12. 2-hour post-prandial serum C peptide levels

    Changes in 2-hour post-prandial serum C peptide levels relative to baseline after 16 weeks of treatment.

    Time frame: Baseline to 16 weeks

  13. Percentage change in liver fat content relative to baseline

    Evaluate the percentage change in liver fat content measured by Magnetic resonance imaging-proton density fat fraction (MRI-PDFF) relative to baseline after 16 weeks of treatment.

    Time frame: Baseline to 16 weeks

  14. Changes relative to baseline in body mass index (BMI)

    Changes in BMI (=body weight/height\^2) relative to baseline after 16 weeks of treatment.

    Time frame: Baseline to 16 weeks

  15. Changes relative to baseline in body composition

    Changes in body composition relative to baseline after 16 weeks of treatment, including lean mass, fat mass, body fat percentage and etc.

    Time frame: Baseline to 16 weeks

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

    Changes in waist circumference and waist-to-hip ratio (=waist circumference/hip circumference) relative to baseline after 16 weeks of treatment.

    Time frame: Baseline to 16 weeks

  17. Changes relative to baseline in liver function

    including alanine aminotransferase, aspartate aminotransferase，ɣ-glutamyltransferase, alkaline phosphatase, lactate dehydrogenase, total bilirubin, direct bilirubin, total protein, albumin, and total bile acid.

    Time frame: Baseline to 16 weeks

  18. Changes relative to baseline in renal function

    including including serum urea nitrogen, serum creatinine, and serum urinary acid.

    Time frame: Baseline to 16 weeks

  19. Changes relative to baseline in lipid profile

    including serum triglycerides, total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol.

    Time frame: Baseline to 16 weeks

  20. Changes relative to baseline in parameters of hepatic fibrosis

    including serum hyaluronic acid, laminin, procollagen type III, and collagen type IV.

    Time frame: Baseline to 16 weeks

07

Study locations

1 site
  • Dep.endocrinology of Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
    Shanghai, Shanghai 200025, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06492330
Lead sponsor
Shanghai Jiao Tong University School of Medicine
Responsible party
Wang Weiqing (Professor, PHD, MD, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Jul 9, 2024
Start date
Jul 19, 2024
Primary completion
Feb 28, 2025
Completion
Apr 22, 2025
Last update
Jun 3, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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