MN-001 in Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia
Primary Purpose
Diabetes Mellitus, Type 2, Hypertriglyceridemia, Non-Alcoholic Fatty Liver Disease
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MN-001
MN-001 placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- MRI-PDFF ≥8 % obtained during the Screening period (baseline MRI-PDFF) or a historic MRI-PDFF ≤8 weeks of randomization.
- Diagnosis or history of Type 2 Diabetes mellitus with hemoglobin A1c (HbA1c) >6.5 and ≤10% at Screening.
- Fasting serum triglycerides (TG) at Screening >150 mg/dL
- On a stable dose of oral antidiabetic therapy for a minimum of 3 months prior to Screening.
Exclusion Criteria:
- Other causes of chronic liver disease (autoimmune, primary biliary cholangitis, HBV, HCV, Wilson's, α-1-antitrypsin deficiency, hemochromatosis, biopsy-proven cirrhosis, hepatocellular carcinoma);
- Documented history of advanced liver fibrosis
- Evidence of cirrhosis, hepatic decompensation, portal hypertension including splenomegaly, ascites, encephalopathy and/or esophageal varices;
- Diagnosis or history of Diabetes mellitus type 1;
Sites / Locations
- Jubilee Clinical Research, Inc.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
MN-001
MN-001 Placebo
Arm Description
The placebo comparator is a tablet identical in appearance to MN-001.
Outcomes
Primary Outcome Measures
Mean change in controlled attenuation parameter (CAP) score by sound-based elastography at Week 24
Mean change from baseline in fasting serum triglyceride levels at Week 24
Secondary Outcome Measures
Safety and tolerability of MN-001
Incidence of adverse events, abnormal clinical laboratory results
Mean change from baseline in lipids
Changes in lipids (HDL-C, LDL-C, total cholesterol) after MN-001 treatment for 24 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05464784
Brief Title
MN-001 in Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 22, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MediciNova
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 U.S.
Patients will be randomized 1:1 to receive either 500 mg/day 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Hypertriglyceridemia, Non-Alcoholic Fatty Liver Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MN-001
Arm Type
Experimental
Arm Title
MN-001 Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo comparator is a tablet identical in appearance to MN-001.
Intervention Type
Drug
Intervention Name(s)
MN-001
Intervention Description
MN-001 is a novel, orally bioavailable small molecule compound
Intervention Type
Drug
Intervention Name(s)
MN-001 placebo
Intervention Description
The placebo tablet is identical in appearance to the MN-001 tablet, and contains excipients of MN-001.
Primary Outcome Measure Information:
Title
Mean change in controlled attenuation parameter (CAP) score by sound-based elastography at Week 24
Time Frame
Week 24
Title
Mean change from baseline in fasting serum triglyceride levels at Week 24
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Safety and tolerability of MN-001
Description
Incidence of adverse events, abnormal clinical laboratory results
Time Frame
Baseline to Week 24
Title
Mean change from baseline in lipids
Description
Changes in lipids (HDL-C, LDL-C, total cholesterol) after MN-001 treatment for 24 weeks
Time Frame
Baseline to Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
FibroScan® CAP score ≥ 248 dB/m within 8 weeks of randomization.
Diagnosis or history of Type 2 Diabetes mellitus with hemoglobin A1c (HbA1c) >6.5 and ≤10% at Screening.
Fasting serum triglycerides (TG) at Screening >150 mg/dL
On a stable dose of oral antidiabetic therapy for a minimum of 3 months prior to Screening.
Exclusion Criteria:
Other causes of chronic liver disease (autoimmune, primary biliary cholangitis, HBV, HCV, Wilson's, α-1-antitrypsin deficiency, hemochromatosis, biopsy-proven cirrhosis, hepatocellular carcinoma);
Documented history of advanced liver fibrosis
Evidence of cirrhosis, hepatic decompensation, portal hypertension including splenomegaly, ascites, encephalopathy and/or esophageal varices;
Diagnosis or history of Diabetes mellitus type 1;
Weight change >5% within last 3 months of Screening visit;
Active gastrointestinal disease or history of gastric bypass surgery which could interfere with the absorption of oral medication;
History of clinically significant acute cardiac event within 6 months of Screening;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matsuda
Phone
(858) 373-1500
Email
clinicaltrialinfo@medicinova.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazuko Matsuda, MD PhD MPH
Organizational Affiliation
Medicinova Inc
Official's Role
Study Director
Facility Information:
Facility Name
Jubilee Clinical Research, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew O'Sullivan, M.A.
Phone
702-631-5000
Email
mosullivan@jcr-lv.com
First Name & Middle Initial & Last Name & Degree
Elliott Shin, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MN-001 in Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia
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