Type 2 DiabetesNCT07570810
Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MAFLD Patients With Obesity and T2DM
A study testing CS0159 and Semaglutide in people with Type 2 Diabetes and Obesity, run by Shanghai Jiao Tong University School of Medicine.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes, Obesity, Non-alcoholic Fatty Liver Disease
- What is being tested?
- CS0159 and Semaglutide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
- Conditions
- Type 2 Diabetes, Obesity, Non-alcoholic Fatty Liver Disease
- Being tested
- CS0159, CS0159 placebo, Semaglutide
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS0159Drug
The intervention will include a 12-week treatment period. During the 12-week treatment period, subjects will receive 4mg CS0159 (oral, once daily).
CS0159 placeboDrug
The intervention will include a 12-week treatment period. During the 12-week treatment period, subjects will receive CS0159 placebo (oral, once daily).
SemaglutideDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| 4mg CS0159 | Active comparator | 4mg CS0159 (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly) for 12 weeks Receives: Drug: CS0159; Drug: Semaglutide |
| CS0159 Placebo | Placebo comparator | CS0159 placebo (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly) for 12 weeks Receives: Drug: CS0159 placebo; Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in body weight relative to baseline
Evaluate the percentage change in body weight relative to baseline after 12 weeks of treatment.
Measured: Baseline to 12 weeks
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).
Measured: Baseline to 12 weeks
Secondary outcomes (15)
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
Measured: Baseline to 12 weeks
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
Measured: Baseline to 12 weeks
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).
Measured: Baseline to 12 weeks
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).
Measured: Baseline to 12 weeks
Percentage change in HbA1c relative to baseline
Evaluate the percentage change in glycated hemoglobin (HbA1c) relative to baseline after 12 weeks of treatment.
Measured: Baseline to 12 weeks
Changes relative to baseline in BMI
Changes in body mass index (BMI) relative to baseline after 12 weeks of administration
Measured: Baseline to 12 weeks
Changes relative to baseline in body composition
Changes in body composition analysis relative to baseline after 12 weeks of administration
Measured: Baseline to 12 weeks
Changes relative to baseline in waist circumference
Changes in waist circumference relative to baseline after 12 weeks of administration
Measured: Baseline to 12 weeks
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
Measured: Baseline to 12 weeks
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.
Measured: Baseline to 12 weeks
Changes relative to baseline in serum lipid profile
including serum triglycerides, total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol.
Measured: Baseline to 12 weeks
Changes relative to baseline in plasma glucose levels
including fasting plasma glucose and 2-hour post-prandial plasma glucose
Measured: Baseline to 12 weeks
Changes relative to baseline in serum insulin levels
including fasting serum insulin and 2-hour post-prandial serum insulin
Measured: Baseline to 12 weeks
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
Measured: Baseline to 12 weeks
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
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Weiqing, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570810
- Sponsor's protocol ID
- MAFLD-CS0159-IIT-E
- Status last verified
- May 2026
- First submitted
- 15 Mar 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07570810
- Acronym / sponsor ID
- MAFLD-CS0159-IIT-E
- Conditions
- Type 2 Diabetes, Obesity, Non-alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4mg CS0159 | Active comparator | Drug: CS0159, Drug: Semaglutide4mg CS0159 (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly) for 12 weeks |
| CS0159 Placebo | Placebo comparator | Drug: CS0159 placebo, Drug: SemaglutideCS0159 placebo (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly) for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CS0159The intervention will include a 12-week treatment period. During the 12-week treatment period, subjects will receive 4mg CS0159 (oral, once daily). | Drug | 4mg CS0159 |
| CS0159 placeboThe intervention will include a 12-week treatment period. During the 12-week treatment period, subjects will receive CS0159 placebo (oral, once daily). | Drug | CS0159 Placebo |
| SemaglutideThe intervention will include a 12-week treatment period. During the 12-week treatment period, subjects will receive 0.5mg Semaglutide (subcutaneous injection, once weekly). | Drug | 4mg CS0159, CS0159 Placebo |
Primary outcome
Percentage change in body weight relative to baseline
Time frame: Baseline to 12 weeks
Evaluate the percentage change in body weight relative to baseline after 12 weeks of treatment.
Changes in energy expenditure
Time frame: Baseline to 12 weeks
The impact of the patient's energy expenditure change relative to the baseline after 12 weeks, assessed by whole-room indirect calorimetry (metabolic chamber).
15 secondary outcomes
Change in patient's weight relative to the baseline
Time frame: Baseline to 12 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Baseline to 12 weeks
Change in patient's glucose oxidation
Time frame: Baseline to 12 weeks
Change in patient's lipid oxidation
Time frame: Baseline to 12 weeks
Percentage change in HbA1c relative to baseline
Time frame: Baseline to 12 weeks
Changes relative to baseline in BMI
Time frame: Baseline to 12 weeks
Changes relative to baseline in body composition
Time frame: Baseline to 12 weeks
Changes relative to baseline in waist circumference
Time frame: Baseline to 12 weeks
Changes relative to baseline in waist to hip ratio (WHR)
Time frame: Baseline to 12 weeks
Changes relative to baseline in serum liver function parameters
Time frame: Baseline to 12 weeks
Changes relative to baseline in serum lipid profile
Time frame: Baseline to 12 weeks
Changes relative to baseline in plasma glucose levels
Time frame: Baseline to 12 weeks
Changes relative to baseline in serum insulin levels
Time frame: Baseline to 12 weeks
Changes in peripheral blood metabolomics and proteomics relative to baseline
Time frame: Baseline to 12 weeks
Changes in fecal metabolites, gut microbiota homeostasis, and fecal gut microbiota metagenome relative to baseline
Time frame: Baseline to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing CS0159 and Semaglutide in people with Type 2 Diabetes and Obesity, run by Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yifei Zhang (+86-13524640378, feifei-a@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in body weight relative to baseline (time frame: Baseline to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.