MN-001 in Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Diabetes Mellitus, Type 2, Hypertriglyceridemia, Non-Alcoholic Fatty Liver Disease
In brief
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).
Key facts
- Study ID
- NCT05464784
- Run by
- MediciNova
- People needed
- 40
- Starts
- 2022-08-22
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-02-05
Who can join
Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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;
Where it is running
- Jubilee Clinical Research, Inc. — Las Vegas, Nevada, United States
- Pinnacle Clinical Research at South Texas Research Institute — Edinburg, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.