Diabetes Mellitus, Type 2Phase 2NCT05464784
MN-001 in Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus, and Hypertriglyceridemia
A Phase 2 study testing MN-001 in people with Diabetes Mellitus, Type 2 and Hypertriglyceridemia, run by MediciNova at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hypertriglyceridemia, Non-Alcoholic Fatty Liver Disease
- What is being tested?
- MN-001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Aug 2022to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pinnacle Clinical Research at South Texas Research Institute
Edinburg, Texas, 78539
Jubilee Clinical Research, Inc.
Las Vegas, Nevada, 89106
About this study
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
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).
- Being tested
- MN-001, MN-001 placebo
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertriglyceridemia, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MN-001Drug
MN-001 is a novel, orally bioavailable small molecule compound
MN-001 placeboDrug
The placebo tablet is identical in appearance to the MN-001 tablet, and contains excipients of MN-001.
| Study group | Role | What they receive |
|---|---|---|
| MN-001 | Experimental | Not described Receives: Drug: MN-001 |
| MN-001 Placebo | Placebo comparator | The placebo comparator is a tablet identical in appearance to MN-001. Receives: Drug: MN-001 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in controlled attenuation parameter (CAP) score by sound-based elastography at Week 24
Measured: Week 24
Mean change from baseline in fasting serum triglyceride levels at Week 24
Measured: Week 24
Secondary outcomes (2)
Safety and tolerability of MN-001
Incidence of adverse events, abnormal clinical laboratory results
Measured: Baseline to Week 24
Mean change from baseline in lipids
Changes in lipids (HDL-C, LDL-C, total cholesterol) after MN-001 treatment for 24 weeks
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start22 Aug 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MediciNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464784
- Sponsor's protocol ID
- MN-001-NATG-202
- Status last verified
- Feb 2026
- First submitted
- 28 Jun 2022
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05464784
- Acronym / sponsor ID
- MN-001-NATG-202
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- MediciNovaIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MN-001 | Experimental | Drug: MN-001 |
| MN-001 Placebo | Placebo comparator | Drug: MN-001 placeboThe placebo comparator is a tablet identical in appearance to MN-001. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MN-001MN-001 is a novel, orally bioavailable small molecule compound | Drug | MN-001 |
| MN-001 placeboThe placebo tablet is identical in appearance to the MN-001 tablet, and contains excipients of MN-001. | Drug | MN-001 Placebo |
Primary outcome
Mean change in controlled attenuation parameter (CAP) score by sound-based elastography at Week 24
Time frame: Week 24
Mean change from baseline in fasting serum triglyceride levels at Week 24
Time frame: Week 24
2 secondary outcomes
Safety and tolerability of MN-001
Time frame: Baseline to Week 24
Mean change from baseline in lipids
Time frame: Baseline to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MN-001 in people with Diabetes Mellitus, Type 2 and Hypertriglyceridemia, run by MediciNova at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in controlled attenuation parameter (CAP) score by sound-based elastography at Week 24 (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.