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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05464784

Enrollment

Registered

2022-07-19

Start date

2022-08-22

Completion date

2026-12-31

Last updated

2026-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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).

Interventions

DRUGMN-001

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

DRUGMN-001 placebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 75 Years

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame	Description
Safety and tolerability of MN-001	Baseline to Week 24	Incidence of adverse events, abnormal clinical laboratory results
Mean change from baseline in lipids	Baseline to Week 24	Changes in lipids (HDL-C, LDL-C, total cholesterol) after MN-001 treatment for 24 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026