MN-001 for Diabetes Mellitus, Type 2

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Jubilee Clinical Research, Inc., Las Vegas, NV
Diabetes Mellitus, Type 2+6 More
MN-001 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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 MRI Proton Density Fat Fraction (MRI-PDFF) at Week 24, and (2) change from baseline in fasting serum triglycerides at Week 24. MRI-PDFF 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).

Eligible Conditions

  • Diabetes Mellitus, Type 2
  • Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD
  • Hypertriglyceridemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Diabetes Mellitus, Type 2

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Week 24

Week 24
Change from baseline in fasting serum triglyceride levels
Change in liver fat content measured by MRI Proton Density Fat Fraction (MRI-PDFF)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Diabetes Mellitus, Type 2

Side Effects for

MN-001 500 mg qd
12%Diarrhea
11%Nausea
10%Headache
7%Dizziness
5%Loose stools
5%Interstitial Cystitis
2%Urinary tract infection
1%Pregnancy
0%infected epidermal cyst
This histogram enumerates side effects from a completed 2006 Phase 2 trial (NCT00295854) in the MN-001 500 mg qd ARM group. Side effects include: Diarrhea with 12%, Nausea with 11%, Headache with 10%, Dizziness with 7%, Loose stools with 5%.

Trial Design

2 Treatment Groups

MN-001
1 of 2
MN-001 Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

40 Total Participants · 2 Treatment Groups

Primary Treatment: MN-001 · Has Placebo Group · Phase 2

MN-001
Drug
Experimental Group · 1 Intervention: MN-001 · Intervention Types: Drug
MN-001 Placebo
Drug
PlaceboComparator Group · 1 Intervention: MN-001 placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MN-001
2005
Completed Phase 2
~320

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 24
Closest Location: Jubilee Clinical Research, Inc. · Las Vegas, NV
Photo of las vegas 1Photo of las vegas 2Photo of las vegas 3
2021First Recorded Clinical Trial
1 TrialsResearching Diabetes Mellitus, Type 2
6 CompletedClinical Trials

Who is running the clinical trial?

MediciNovaLead Sponsor
19 Previous Clinical Trials
1,510 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have Type 2 Diabetes mellitus with hemoglobin A1c (HbA1c) >6.
Fasting serum triglycerides (TG) at Screening >150 mg/dL.
You are on a stable dose of oral antidiabetic therapy for a minimum of 3 months prior to Screening.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.