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Clinical Trials in the USA / NCT05464784
Active, not recruiting Phase 2

MN-001 in Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia

NCT05464784 · tracked via the Priya Life Science USA tracker
Sponsor
MediciNova
Phase
Phase 2
Started
2022-08-22
Last updated
2026-02-05

Condition(s) studied

Diabetes Mellitus, Type 2HypertriglyceridemiaNon-Alcoholic Fatty Liver Disease

Investigational drug(s) / intervention(s)

MN-001MN-001 placebo

MN-001: MN-001 is a novel, orally bioavailable small molecule compound

MN-001 placebo: The placebo tablet is identical in appearance to the MN-001 tablet, and contains excipients of MN-001.

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 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).

Eligibility

Sex
ALL
Min age
21 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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; * Weight change \>5% within last 3 months of Screening visit; * 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;

Primary outcome measure(s)

  • Mean change in controlled attenuation parameter (CAP) score by sound-based elastography at Week 24 — Week 24
  • Mean change from baseline in fasting serum triglyceride levels at Week 24 — Week 24

Trial sites (2)

FacilityCityRegionStatus
Jubilee Clinical Research, Inc. Las Vegas Nevada
Pinnacle Clinical Research at South Texas Research Institute Edinburg Texas

More MediciNova trials in the USA

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Other trials for the same condition

A Study of Macupatide (LY3532226) and Eloralintide (LY3841136), Alone or in Combination, in Adults With Obesity or Overweight and With Type 2 Diabetes Active, not recruiting
Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis Active, not recruiting
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adolescents With Type 2 Diabetes Recruiting
An Active Surveillance Program for Cases of Medullary Thyroid Carcinoma (MTC) Enrolling by invitation
A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05464784 on ClinicalTrials.gov ↗ ← All trials in the USA