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New pill aims to tackle fatty liver and diabetes at once

NCT ID NCT05464784

Disease control Sponsor: MediciNova Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests an oral drug called MN-001 (tipelukast) in 40 adults with non-alcoholic fatty liver disease, type 2 diabetes, and high triglycerides. Participants take either the drug or a placebo daily for 24 weeks. The study measures changes in liver fat and blood fat levels to see if the drug is safe and effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MN-001 (tipelukast)
What this could lead to
If it works, this could point toward a new oral treatment that reduces liver fat and triglycerides in people with fatty liver disease and diabetes.
What could go wrong
This is a small, early-phase trial with only 40 people. The drug may not show enough benefit or could cause side effects. Success in this trial does not guarantee approval.
Why investors are watching

MediciNova is a very small company, so this Phase 2 trial of its drug MN-001 is a major event. The trial tests whether MN-001 can reduce liver fat and triglycerides in patients with fatty liver disease, type 2 diabetes, and high triglycerides. A clear result matters because this single drug is a central part of the company's value.

If it works: If MN-001 shows meaningful reductions in liver fat and triglycerides, the company could have a promising treatment for a common condition. That positive data might attract partners or funding to continue development.

If it fails: Phase 2 trials often fail to show a benefit, and this one has only 40 participants, so results may be unclear. A negative or weak result could hurt the company's prospects, since it has few other assets to fall back on.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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;

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Conditions

The condition(s) this trial relates to.

hypertriglyceridemia metabolic dysfunction-associated steatotic liver disease type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus type 2 Hypertriglyceridemia Non-alcoholic fatty liver disease

Contacts and locations

Locations

  • Jubilee Clinical Research, Inc.

    Las Vegas, Nevada, 89106, United States

  • Pinnacle Clinical Research at South Texas Research Institute

    Edinburg, Texas, 78539, United States

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