NCT05464784Active, not recruitingPhase 2
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- MediciNova
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Mean change from baseline in fasting serum triglyceride levels at Week 24
Study Overview
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. FibroScan® 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 21 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Arms & Interventions
MN-001
Experimental
Intervention: MN-001 (Drug)
MN-001 Placebo
Placebo Comparator
The placebo comparator is a tablet identical in appearance to MN-001.
Intervention: MN-001 placebo (Drug)
Outcomes
Primary Outcomes
Mean change from baseline in fasting serum triglyceride levels at Week 24
Time Frame: Week 24
Mean change in controlled attenuation parameter (CAP) score by sound-based elastography at Week 24
Time Frame: Week 24
Secondary Outcomes
- Mean change from baseline in lipids(Baseline to Week 24)
- Safety and tolerability of MN-001(Baseline to Week 24)
Investigators
Study Sites (2)
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