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Not yet recruitingNCT07570810Updated May 6, 2026

Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MAFLD Patients With Obesity and T2DM

An interventional study of CS0159 and CS0159 placebo in Type 2 Diabetes, Obesity and Non-alcoholic Fatty Liver Disease, sponsored by Shanghai Jiao Tong University School of Medicine. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-06.

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

Phase
Not applicable
Study type
Interventional
Enrollment
30
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 metabolic dysfunction-associated fatty liver disease (MAFLD) patients with obesity and type 2 diabetes (T2DM).

Read the detailed description

This is an exploratory study to evaluate the efficacy, safety, and tolerability of CS0159 in combination with Semaglutide in MAFLD patients with obesity and T2DM. Approximately 30 patients were randomly assigned to two groups in a 1:1 ratio for treatment for 12 weeks.

02

Conditions studied

  • Type 2 Diabetes
  • Obesity
  • Non-alcoholic Fatty Liver Disease
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's planned enrollment of 30 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 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.
  • 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    4mg CS0159

    4mg CS0159 (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly) for 12 weeks

    Drug: CS0159 · Drug: Semaglutide

  • Placebo comparator
    CS0159 Placebo

    CS0159 placebo (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly) for 12 weeks

    Drug: CS0159 placebo · Drug: Semaglutide

Interventions

  • DrugCS0159

    The intervention will include a 12-week treatment period. During the 12-week treatment period, subjects will receive 4mg CS0159 (oral, once daily).

  • DrugCS0159 placebo

    The intervention will include a 12-week treatment period. During the 12-week treatment period, subjects will receive CS0159 placebo (oral, once daily).

  • DrugSemaglutide

    The intervention will include a 12-week treatment period. During the 12-week treatment period, subjects will receive 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 12 weeks of treatment.

    Time frame: Baseline to 12 weeks

  2. Changes in energy expenditure

    The impact of the patient's energy expenditure change relative to the baseline after 12 weeks, assessed by whole-room indirect calorimetry (metabolic chamber).

    Time frame: Baseline to 12 weeks

Secondary outcomes

  1. Change in patient's weight relative to the baseline

    Evaluation of the change in patient's weight relative to the baseline after 12 weeks with CS0159

    Time frame: Baseline to 12 weeks

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

    Evaluate the safety and tolerability of CS0159 combined with semaglutide during a 12-week treatment period

    Time frame: Baseline to 12 weeks

  3. Change in patient's glucose oxidation

    Evaluation of the effect of CS0159 on glucose and lipid oxidation in patients relative to baseline after 12 weeks of administration, assessed by whole-room indirect calorimetry (metabolic chamber).

    Time frame: Baseline to 12 weeks

  4. Change in patient's lipid oxidation

    Evaluation of the effect of CS0159 on glucose and lipid oxidation in patients relative to baseline after 12 weeks of administration, assessed by whole-room indirect calorimetry (metabolic chamber).

    Time frame: Baseline to 12 weeks

  5. Percentage change in HbA1c relative to baseline

    Evaluate the percentage change in glycated hemoglobin (HbA1c) relative to baseline after 12 weeks of treatment.

    Time frame: Baseline to 12 weeks

  6. Changes relative to baseline in BMI

    Changes in body mass index (BMI) relative to baseline after 12 weeks of administration

    Time frame: Baseline to 12 weeks

  7. Changes relative to baseline in body composition

    Changes in body composition analysis relative to baseline after 12 weeks of administration

    Time frame: Baseline to 12 weeks

  8. Changes relative to baseline in waist circumference

    Changes in waist circumference relative to baseline after 12 weeks of administration

    Time frame: Baseline to 12 weeks

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

    Changes in waist to hip ratio (WHR) relative to baseline after 12 weeks of administration

    Time frame: Baseline to 12 weeks

  10. Changes relative to baseline in serum liver function parameters

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

    Time frame: Baseline to 12 weeks

  11. Changes relative to baseline in serum lipid profile

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

    Time frame: Baseline to 12 weeks

  12. Changes relative to baseline in plasma glucose levels

    including fasting plasma glucose and 2-hour post-prandial plasma glucose

    Time frame: Baseline to 12 weeks

  13. Changes relative to baseline in serum insulin levels

    including fasting serum insulin and 2-hour post-prandial serum insulin

    Time frame: Baseline to 12 weeks

  14. Changes in peripheral blood metabolomics and proteomics relative to baseline

    Changes in peripheral blood metabolomics and proteomics relative to baseline after 12 weeks of administration

    Time frame: Baseline to 12 weeks

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

    Changes in fecal metabolites, gut microbiota homeostasis, and fecal gut microbiota metagenome relative to baseline after 12 weeks of administration

    Time frame: Baseline to 12 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07570810
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
May 6, 2026
Start date
Jun 1, 2026 (estimated)
Primary completion
Nov 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
May 6, 2026

Study contacts

Yifei Zhang
Contact
feifei-a@163.com
+86-13524640378

Oversight

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

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This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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