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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
My diabetes type 2 has an HbA1c level between 6.5% and 10%.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change from baseline in fasting serum triglyceride levels at Week 24
Mean change in controlled attenuation parameter (CAP) score by sound-based elastography at Week 24
Secondary outcome measures
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
MN-001 500 mg BID
Placebo
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
1,480 Total Patients Enrolled
Kazuko Matsuda, MD PhD MPHStudy DirectorMedicinova Inc
4 Previous Clinical Trials
339 Total Patients Enrolled

Media Library

MN-001 (Leukotriene Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05464784 — Phase 2
High Triglycerides Research Study Groups: MN-001, MN-001 Placebo
High Triglycerides 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential side effects of MN-001?

"Even though there is no clinical data yet supporting MN-001's efficacy, it has been given a score of 2 due to the phase 2 trial data suggesting it is safe."

Answered by AI

If I volunteer for this research, am I able to participate?

"40 individuals aged 21 to 75 that have been diagnosed with type 2 diabetes mellitus are needed for this study. Applicants must meet the following requirements: MRI-PDFF ≥8 % obtained during the Screening period (baseline MRI-PDFF) or a historic MRI-PDFF ≤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"

Answered by AI

How many participants are being allowed to join this research project?

"That is correct. The information available on clinicaltrials.gov reveals that the study is currently looking for participants. This particular trial was first posted on 8/22/2022 and was edited most recently on 8/24/2022. As of now, the plan is to enroll 40 patients from 1 location."

Answered by AI

Does this test exclude patients who are elderly?

"The age requirement to participate in this trial is that patients must be 21-75 years old."

Answered by AI

Are there still opportunities for people to enroll in this research project?

"The listed information on clinicaltrials.gov reveals that this study is looking for more participants and was last edited on 8/24/2022."

Answered by AI

Who else is applying?

What state do they live in?
Nevada
What portion of applicants met pre-screening criteria?
Did not meet criteria
What site did they apply to?
Jubilee Clinical Research, Inc.

Why did patients apply to this trial?

Looking to try something different. I've tried other medications that have not worked.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
MN-001 in Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia
2022. "MN-001 in Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05464784.
All > Fatty Liver Disease > Diabetes Type 2
~4 spots leftby Jun 2024
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