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

NCT06492330 | Completed

• 1 other identifier: MASH-CS0159-IIT
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

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.

  Baseline to 16 weeks

Secondary Outcomes (20)

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

  Baseline to 16 weeks

• Patient Health Questionnaire 9 (PHQ-9)

  Baseline to 16 weeks

• Short form 36 health survey questionnaire (SF-36)

  Baseline to 16 weeks

• Visual analog scale for pruritus and 5-D itch scale

  Baseline to 16 weeks

• Proportion of subjects achieving ≥5% weight loss

  Baseline to 16 weeks

Study Arms (2)

4mg CS0159

ACTIVE COMPARATOR

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

Drug: CS0159

CS0159 Placebo

PLACEBO COMPARATOR

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

Drug: CS0159 placebo

Interventions

CS0159 DRUG

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).

4mg CS0159

CS0159 placebo DRUG

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).

CS0159 Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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.
• \. Use of glucose-lowering medication in the 3 months prior to randomization.
• \. 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.
• \. 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.
• \. Subjects with T1DM, monogenic diabetes, diabetes caused by pancreatic damage, or other secondary diabetes.
• \. Subjects with a history of severe pruritus.
• \. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy.
• \. Thyroid C-cell tumour or family history, multiple endocrine neoplasia type 2 or family history.
• \. History of acute or chronic pancreatitis.
• \. Subjects with Child-Pugh class B or C grade cirrhosis.
• \. HBsAg positive, HCV Ab positive, HIV Ab positive, TP Ab positive.
• \. 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.
• \. Diseases that interfere with the absorption, distribution, metabolism or excretion.
• \. Gastrointestinal diseases that affect food digestion and absorption.
• \. 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PHD, MD

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 9, 2024
• Study Start: July 19, 2024
• Primary Completion: February 28, 2025
• Study Completion: April 22, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

CN (1)