Metabolic Dysfunction-Associated Steatohepatitis (MASH)NCT06492330
Efficacy and Safety of CS0159 Combined With Semaglutide in MASH Patients With Obesity and T2DM
A study testing CS0159 in people with Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Obesity, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This is an exploratory study evaluating CS0159 in combination with Semaglutide in MASH patients with obesity and T2DM. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatohepatitis (MASH), Obesity, Diabetes Mellitus, Type 2
- What is being tested?
- CS0159
- 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
- 62 participants
- Where
- 1 siteChina
- Study dates
- 19 Jul 2024to 22 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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. 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.
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.
Show all 24Show fewer
- 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
1 site in 1 country.
China1 site
Dep.endocrinology of Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: 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
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.
- Conditions
- Metabolic Dysfunction-Associated Steatohepatitis (MASH), Obesity, Diabetes Mellitus, Type 2
- Being tested
- CS0159, CS0159 placebo
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
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 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 placeboDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| 4mg CS0159 | Active comparator | 4mg CS0159 (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly) for 16 weeks Receives: Drug: CS0159 |
| CS0159 Placebo | Placebo comparator | CS0159 placebo (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly) for 16 weeks Receives: Drug: CS0159 placebo |
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 16 weeks of treatment.
Measured: Baseline to 16 weeks
Secondary outcomes (20)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Safety outcomes
Measured: Baseline to 16 weeks
Patient Health Questionnaire 9 (PHQ-9)
Safety outcomes
Measured: Baseline to 16 weeks
Short form 36 health survey questionnaire (SF-36)
Safety outcomes
Measured: Baseline to 16 weeks
Visual analog scale for pruritus and 5-D itch scale
Safety outcomes
Measured: Baseline to 16 weeks
Proportion of subjects achieving ≥5% weight loss
Proportion of subjects achieving ≥5% weight loss from baseline after 16 weeks of treatment.
Measured: Baseline to 16 weeks
Percentage change in HbA1c relative to baseline
Evaluate the percentage change in glycated hemoglobin (HbA1c) relative to baseline after 16 weeks of treatment.
Measured: Baseline to 16 weeks
Fasting plasma glucose levels
Changes in fasting plasma glucose levels relative to baseline after 16 weeks of treatment.
Measured: Baseline to 16 weeks
2-hour post-prandial plasma glucose levels
Changes in 2-hour post-prandial plasma glucose levels relative to baseline after 16 weeks of treatment.
Measured: Baseline to 16 weeks
Fasting serum insulin levels
Changes in fasting serum insulin levels relative to baseline after 16 weeks of treatment.
Measured: Baseline to 16 weeks
2-hour post-prandial serum insulin levels
Changes in 2-hour post-prandial serum insulin levels relative to baseline after 16 weeks of treatment.
Measured: Baseline to 16 weeks
Fasting serum C peptide levels
Changes in fasting serum C peptide levels relative to baseline after 16 weeks of treatment.
Measured: Baseline to 16 weeks
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.
Measured: Baseline to 16 weeks
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.
Measured: Baseline to 16 weeks
Changes relative to baseline in body mass index (BMI)
Changes in BMI (=body weight/height^2) relative to baseline after 16 weeks of treatment.
Measured: Baseline to 16 weeks
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.
Measured: Baseline to 16 weeks
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.
Measured: Baseline to 16 weeks
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.
Measured: Baseline to 16 weeks
Changes relative to baseline in renal function
including including serum urea nitrogen, serum creatinine, and serum urinary acid.
Measured: Baseline to 16 weeks
Changes relative to baseline in lipid profile
including serum triglycerides, total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol.
Measured: Baseline to 16 weeks
Changes relative to baseline in parameters of hepatic fibrosis
including serum hyaluronic acid, laminin, procollagen type III, and collagen type IV.
Measured: Baseline to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start19 Jul 2024
- Primary completion28 Feb 2025
- Study completion22 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Steatohepatitis (MASH)Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
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
- NCT06492330
- Sponsor's protocol ID
- MASH-CS0159-IIT
- Status last verified
- May 2025
- First submitted
- 25 Jun 2024
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06492330
- Acronym / sponsor ID
- MASH-CS0159-IIT
- Conditions
- Metabolic Dysfunction-Associated Steatohepatitis (MASH), Obesity, Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 19 Jul 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 22 Apr 2025 (actual)
- First posted
- 9 Jul 2024 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4mg CS0159 | Active comparator | Drug: CS01594mg CS0159 (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly) for 16 weeks |
| CS0159 Placebo | Placebo comparator | Drug: CS0159 placeboCS0159 placebo (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly) for 16 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
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 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). | Drug | 4mg CS0159 |
| CS0159 placeboThe 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). | Drug | CS0159 Placebo |
Primary outcome
Percentage change in body weight relative to baseline
Time frame: Baseline to 16 weeks
Evaluate the percentage change in body weight relative to baseline after 16 weeks of treatment.
20 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Baseline to 16 weeks
Patient Health Questionnaire 9 (PHQ-9)
Time frame: Baseline to 16 weeks
Short form 36 health survey questionnaire (SF-36)
Time frame: Baseline to 16 weeks
Visual analog scale for pruritus and 5-D itch scale
Time frame: Baseline to 16 weeks
Proportion of subjects achieving ≥5% weight loss
Time frame: Baseline to 16 weeks
Percentage change in HbA1c relative to baseline
Time frame: Baseline to 16 weeks
Fasting plasma glucose levels
Time frame: Baseline to 16 weeks
2-hour post-prandial plasma glucose levels
Time frame: Baseline to 16 weeks
Fasting serum insulin levels
Time frame: Baseline to 16 weeks
2-hour post-prandial serum insulin levels
Time frame: Baseline to 16 weeks
Fasting serum C peptide levels
Time frame: Baseline to 16 weeks
2-hour post-prandial serum C peptide levels
Time frame: Baseline to 16 weeks
Percentage change in liver fat content relative to baseline
Time frame: Baseline to 16 weeks
Changes relative to baseline in body mass index (BMI)
Time frame: Baseline to 16 weeks
Changes relative to baseline in body composition
Time frame: Baseline to 16 weeks
Changes relative to baseline in waist circumference and waist-to-hip ratio (WHR)
Time frame: Baseline to 16 weeks
Changes relative to baseline in liver function
Time frame: Baseline to 16 weeks
Changes relative to baseline in renal function
Time frame: Baseline to 16 weeks
Changes relative to baseline in lipid profile
Time frame: Baseline to 16 weeks
Changes relative to baseline in parameters of hepatic fibrosis
Time frame: Baseline to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CS0159 in people with Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Obesity, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 8 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: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 16 weeks). 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 3 Jun 2025.