NCT05464784Active, not recruitingPhase 2
MN-001 in Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia
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
Source: ClinicalTrials.gov · Last updated 5 Feb 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 28 Jun 2022
- Start date
- 22 Aug 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- MediciNova
- NCT number
- NCT05464784
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 22 Aug 2022 to the primary completion date, 31 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
- 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;
Other
- Weight change \>5% within last 3 months of Screening visit;
Who the study is looking for
- 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.
Age in the registry: 21 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pinnacle Clinical Research at South Texas Research Institute Coordinator of this site? Confirm its status | Edinburg | United States | Unknown status |
| Jubilee Clinical Research, Inc. Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.