Trials / Completed
CompletedNCT02681055
Open-Label Study To Evaluate MN-001 on HDL & Triglyceride in NASH & NAFLD Subjects
An Open-Label Study To Evaluate The Efficacy, Safety, Tolerability and PK of MN-001 (Tipelukast) on HDL Function and Serum Triglyceride Levels in NASH and Non-Alcoholic Fatty Liver Disease (NAFLD) Subjects With Hypertriglyceridemia
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- MediciNova · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center, proof-of-principle, open-label study designed to evaluate the efficacy, safety, and tolerability of MN-001 in non-alcoholic steatohepatitis (NASH) and Non-Alcoholic Fatty Liver Disease (NAFLD) subjects with hypertriglyceridemia.
Detailed description
The study will consist a Screening Phase (up to 4 months) followed by a Treatment Phase (12 weeks), and a Follow-up visit (within 1 week after the last dose). A total of 40 male and female subjects ≥18 years of age are planned to be enrolled. During the Screening Phase, subjects will be assessed for study eligibility. After signing the informed consent form, the following assessments will be performed: medical history including review of prior and current medications, physical examination including height and body weight, waist circumference, vital signs and an electrocardiogram. Clinical labs, routine chemistries, hematology, coagulation profile, urinalysis and a serum pregnancy test will be collected as well as cytokeratin-18 (CK-18), a biomarker for NASH diagnosis. An alcohol consumption questionnaire will be administered and a MRI scan of the liver will be performed. Serum fibrosis markers, the Fib-4 index (age, AST, ALT, PLT) and NAFLD fibrosis score (age, BMI, AST/ALT ratio, IFG/DM, PLT, Albumin) will be calculated.
Conditions
- Non-alcoholic Steatohepatitis
- Hypertriglyceridemia
- Non-alcoholic Fatty Liver Disease
- Hypercholesterolemia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MN-001 | MN-001 is a novel, orally bioavailable small molecule compound which demonstrates anti-inflammatory activity |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2018-05-30
- Completion
- 2019-10-01
- First posted
- 2016-02-12
- Last updated
- 2023-03-15
- Results posted
- 2023-03-15
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02681055. Inclusion in this directory is not an endorsement.