Ignite Creation Date:
2024-07-17 @ 11:14 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492330
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-25
Brief Title:
Efficacy and Safety of CS0159 Combined With Semaglutide in MASH Patients With Obesity and T2DM
Sponsor:
Shanghai Jiao Tong University School of Medicine
Organization:
Shanghai Jiao Tong University School of Medicine
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 kgm2 will be used as a randomized stratification factor and patients will be randomly assigned in a 11 ratio
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None