Ignite Creation Date:
2024-05-06 @ 5:53 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05464784
Status:
RECRUITING
Last Update Posted:
2023-09-29
First Post:
2022-06-28
Brief Title:
MN-001 in Non-alcoholic Fatty Liver Disease Type 2 Diabetes Mellitus and Hypertriglyceridemia
Sponsor:
MediciNova
Organization:
MediciNova
Study Overview
Official Title:
A Phase 2 Double-Blind Randomized Placebo-Controlled Study to Evaluate the Safety Tolerability and Efficacy of MN-001 in Patients Diagnosed With Non-alcoholic Fatty Liver Disease Type 2 Diabetes Mellitus and Hypertriglyceridemia
Status:
RECRUITING
Status Verified Date:
2023-09
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:
The design of the Phase 2 clinical trial includes the following elements
Multi-center two-arm randomized double-blind placebo-controlled trial to evaluate MN-001 tipelukast vs placebo in approximately 40 patients in the US
Patients will be randomized 11 to receive either 500 mgday of MN-001 tipelukast or placebo for 24 weeks
The co-primary endpoints are 1 change from baseline in liver fat content measured by controlled attenuation parameter CAP score at Week 24 and 2 change from baseline in fasting serum triglycerides at Week 24 FebroScan is a non-invasive quantitative and accurate measure of liver fat content commonly used in early phase trials to measure treatment response
Secondary endpoints include safety and tolerability and changes in lipid profile HDL-C LDL-C and total cholesterol
Multi-center two-arm randomized double-blind placebo-controlled trial to evaluate MN-001 tipelukast vs placebo in approximately 40 patients in the US
Patients will be randomized 11 to receive either 500 mgday of MN-001 tipelukast or placebo for 24 weeks
The co-primary endpoints are 1 change from baseline in liver fat content measured by controlled attenuation parameter CAP score at Week 24 and 2 change from baseline in fasting serum triglycerides at Week 24 FebroScan is a non-invasive quantitative and accurate measure of liver fat content commonly used in early phase trials to measure treatment response
Secondary endpoints include safety and tolerability and changes in lipid profile HDL-C LDL-C and total cholesterol
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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