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

May 31, 2025 updated by: Wang Weiqing, Shanghai Jiao Tong University School of Medicine

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 4mg CS0159
4mg CS0159 (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly) for 16 weeks
Drug: 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).
Placebo Comparator: CS0159 Placebo
CS0159 placebo (oral, once daily) + 0.5mg Semaglutide (subcutaneous injection, once weekly) for 16 weeks
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to 16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: Baseline to 16 weeks
Safety outcomes
Baseline to 16 weeks
Patient Health Questionnaire 9 (PHQ-9)
Time Frame: Baseline to 16 weeks
Safety outcomes
Baseline to 16 weeks
Short form 36 health survey questionnaire (SF-36)
Time Frame: Baseline to 16 weeks
Safety outcomes
Baseline to 16 weeks
Visual analog scale for pruritus and 5-D itch scale
Time Frame: Baseline to 16 weeks
Safety outcomes
Baseline to 16 weeks
Proportion of subjects achieving ≥5% weight loss
Time Frame: Baseline to 16 weeks
Proportion of subjects achieving ≥5% weight loss from baseline after 16 weeks of treatment.
Baseline to 16 weeks
Percentage change in HbA1c relative to baseline
Time Frame: Baseline to 16 weeks
Evaluate the percentage change in glycated hemoglobin (HbA1c) relative to baseline after 16 weeks of treatment.
Baseline to 16 weeks
Fasting plasma glucose levels
Time Frame: Baseline to 16 weeks
Changes in fasting plasma glucose levels relative to baseline after 16 weeks of treatment.
Baseline to 16 weeks
2-hour post-prandial plasma glucose levels
Time Frame: Baseline to 16 weeks
Changes in 2-hour post-prandial plasma glucose levels relative to baseline after 16 weeks of treatment.
Baseline to 16 weeks
Fasting serum insulin levels
Time Frame: Baseline to 16 weeks
Changes in fasting serum insulin levels relative to baseline after 16 weeks of treatment.
Baseline to 16 weeks
2-hour post-prandial serum insulin levels
Time Frame: Baseline to 16 weeks
Changes in 2-hour post-prandial serum insulin levels relative to baseline after 16 weeks of treatment.
Baseline to 16 weeks
Fasting serum C peptide levels
Time Frame: Baseline to 16 weeks
Changes in fasting serum C peptide levels relative to baseline after 16 weeks of treatment.
Baseline to 16 weeks
2-hour post-prandial serum C peptide levels
Time Frame: Baseline to 16 weeks
Changes in 2-hour post-prandial serum C peptide levels relative to baseline after 16 weeks of treatment.
Baseline to 16 weeks
Percentage change in liver fat content relative to baseline
Time Frame: Baseline to 16 weeks
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.
Baseline to 16 weeks
Changes relative to baseline in body mass index (BMI)
Time Frame: Baseline to 16 weeks
Changes in BMI (=body weight/height^2) relative to baseline after 16 weeks of treatment.
Baseline to 16 weeks
Changes relative to baseline in body composition
Time Frame: Baseline to 16 weeks
Changes in body composition relative to baseline after 16 weeks of treatment, including lean mass, fat mass, body fat percentage and etc.
Baseline to 16 weeks
Changes relative to baseline in waist circumference and waist-to-hip ratio (WHR)
Time Frame: Baseline to 16 weeks
Changes in waist circumference and waist-to-hip ratio (=waist circumference/hip circumference) relative to baseline after 16 weeks of treatment.
Baseline to 16 weeks
Changes relative to baseline in liver function
Time Frame: Baseline to 16 weeks
including alanine aminotransferase, aspartate aminotransferase，ɣ-glutamyltransferase, alkaline phosphatase, lactate dehydrogenase, total bilirubin, direct bilirubin, total protein, albumin, and total bile acid.
Baseline to 16 weeks
Changes relative to baseline in renal function
Time Frame: Baseline to 16 weeks
including including serum urea nitrogen, serum creatinine, and serum urinary acid.
Baseline to 16 weeks
Changes relative to baseline in lipid profile
Time Frame: Baseline to 16 weeks
including serum triglycerides, total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol.
Baseline to 16 weeks
Changes relative to baseline in parameters of hepatic fibrosis
Time Frame: Baseline to 16 weeks
including serum hyaluronic acid, laminin, procollagen type III, and collagen type IV.
Baseline to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 19, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 22, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MASH-CS0159-IIT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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