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Leukotriene Inhibitor

MN-001 for Non-alcoholic Fatty Liver Disease

Phase 2
Recruiting
Research Sponsored by MediciNova
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis or history of Type 2 Diabetes mellitus with hemoglobin A1c (HbA1c) >6.5 and ≤10% at Screening
Be older than 18 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 24

Summary

This trial will test whether the drug MN-001 (tipelukast) is effective in reducing liver fat content and fasting serum triglycerides in patients, compared to placebo. The trial will also assess the safety and tolerability of the drug.

Who is the study for?
This trial is for adults with Non-alcoholic Fatty Liver Disease and Type 2 Diabetes who have high triglycerides, are on stable diabetes medication, and show a certain level of liver fat. People can't join if they've had significant weight changes recently, certain gastrointestinal issues or surgeries, advanced liver fibrosis or cirrhosis, recent severe heart events, or other specific liver diseases.
What is being tested?
The study tests MN-001 (tipelukast) against a placebo in about 40 patients to see its effect on liver fat content and fasting serum triglycerides over 24 weeks. Patients will be randomly assigned to either the drug or placebo group in equal numbers.
What are the potential side effects?
While the trial's description doesn't list specific side effects of MN-001 (tipelukast), common concerns may include potential digestive disturbances due to its action on the liver and possible interactions with existing medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My diabetes type 2 has an HbA1c level between 6.5% and 10%.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have no stomach or bowel problems that could affect medicine absorption.
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I have had a serious heart problem in the last 6 months.
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I have a severe scarring of the liver.
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I have liver issues, including cirrhosis or signs of worsening liver function.
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I have a chronic liver condition not caused by alcohol.
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I have been diagnosed with Type 1 Diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Mean change from baseline in lipids
Safety and tolerability of MN-001

Side effects data

From 2006 Phase 2 trial • 296 Patients • NCT00295854
23%
Diarrhea
13%
Loose stools
10%
Nausea
9%
Headache
6%
Urinary tract infection
1%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
MN-001 500 mg BID
MN-001 500 mg qd

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MN-001Experimental Treatment1 Intervention
Group II: MN-001 PlaceboPlacebo Group1 Intervention
The placebo comparator is a tablet identical in appearance to MN-001.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MN-001
2005
Completed Phase 2
~320

Find a Location

Who is running the clinical trial?

MediciNovaLead Sponsor
19 Previous Clinical Trials
1,474 Total Patients Enrolled
Kazuko Matsuda, MD PhD MPHStudy DirectorMedicinova Inc
4 Previous Clinical Trials
333 Total Patients Enrolled

Media Library

MN-001 (Leukotriene Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05464784 — Phase 2
Diabetes Research Study Groups: MN-001, MN-001 Placebo
Diabetes Clinical Trial 2023: MN-001 Highlights & Side Effects. Trial Name: NCT05464784 — Phase 2
MN-001 (Leukotriene Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05464784 — Phase 2
~13 spots leftby Dec 2025
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