Efficacy and Safety of CS0159 Combined With Semaglutide in MASH Patients With Obesity and T2DM
NCT Number: NCT06492330
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Metabolic Dysfunction-Associated Steatohepatitis (MASH)|Obesity|Diabetes Mellitus, Type 2
Interventions: DRUG: CS0159|DRUG: CS0159 placebo
Sponsor: Shanghai Jiao Tong University School of Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-05
Completion Date: 2025-06-28
Locations: Dep.endocrinology of Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, 200025, China

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

Primary Outcome Measures: 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 Outcome Measures: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, Safety outcomes, Baseline to 16 weeks|Patient Health Questionnaire 9 (PHQ-9), Safety outcomes, Baseline to 16 weeks|Short form 36 health survey questionnaire (SF-36), Safety outcomes, Baseline to 16 weeks|Visual analog scale for pruritus and 5-D itch scale, Safety outcomes, 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., 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., Baseline to 16 weeks|Fasting plasma glucose levels, 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, 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, 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, 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, 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, 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, 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), 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, 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), 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, 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, including including serum urea nitrogen, serum creatinine, and serum urinary acid., 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., 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., Baseline to 16 weeks