NCT06492330

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

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

Interventions

Type	Name	Description
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).
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).

Timeline

• Start date: 2024-07-19
• Primary completion: 2025-02-28
• Completion: 2025-04-22
• First posted: 2024-07-09
• Last updated: 2025-06-03

Locations

1 site across 1 country: China