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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of MN-001 in Patients Diagnosed With Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05464784
• Other study ID #: MN-001-NATG-202
• Status: Recruiting
• Phase: Phase 2
• Start date: August 22, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: MediciNova
• Contact: Matsuda
• Phone: (858) 373-1500
• Email: clinicaltrialinfo[@]medicinova.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. FebroScan 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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, a-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;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Fatty Liver
• Hypertriglyceridemia
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Jubilee Clinical Research, Inc.	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
MediciNova

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in controlled attenuation parameter (CAP) score by sound-based elastography at Week 24		Week 24
Primary	Mean change from baseline in fasting serum triglyceride levels at Week 24		Week 24
Secondary	Safety and tolerability of MN-001	Incidence of adverse events, abnormal clinical laboratory results	Baseline to Week 24
Secondary	Mean change from baseline in lipids	Changes in lipids (HDL-C, LDL-C, total cholesterol) after MN-001 treatment for 24 weeks	Baseline to Week 24