MN-001 for Non-alcoholic Fatty Liver Disease
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: MediciNova
Must be taking: Oral antidiabetics
Disqualifiers: Chronic liver disease, Advanced liver fibrosis, Diabetes type 1, others
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?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).
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must be on a stable dose of oral antidiabetic therapy for at least 3 months before joining the trial.
What data supports the effectiveness of the drug MN-001 (Tipelukast) for treating non-alcoholic fatty liver disease?
A study on montelukast, a similar drug, showed significant improvement in liver stiffness and liver enzymes in patients with non-alcoholic steatohepatitis (NASH), a more severe form of non-alcoholic fatty liver disease (NAFLD). This suggests that MN-001, which is related to montelukast, might also be effective for NAFLD.
12345How is the drug MN-001 different from other treatments for non-alcoholic fatty liver disease?
MN-001 (Tipelukast) is unique because it is being studied specifically for its potential to treat non-alcoholic fatty liver disease, whereas most current treatments focus on lifestyle changes and a few drugs that have not shown sustained results after stopping treatment.
36789Eligibility Criteria
This trial is for adults with Non-alcoholic Fatty Liver Disease and Type 2 Diabetes who have high triglycerides, are on stable diabetes medication, and show a certain level of liver fat. People can't join if they've had significant weight changes recently, certain gastrointestinal issues or surgeries, advanced liver fibrosis or cirrhosis, recent severe heart events, or other specific liver diseases.Inclusion Criteria
Your blood triglyceride levels are higher than 150 mg/dL after fasting.
I have been on a consistent dose of diabetes medication for at least 3 months.
Your FibroScan® CAP score is higher than 248 dB/m in the last 8 weeks.
+1 more
Exclusion Criteria
I have no stomach or bowel problems that could affect medicine absorption.
I have had a serious heart problem in the last 6 months.
I have a severe scarring of the liver.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either 500 mg/day of MN-001 (tipelukast) or placebo for 24 weeks
24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests MN-001 (tipelukast) against a placebo in about 40 patients to see its effect on liver fat content and fasting serum triglycerides over 24 weeks. Patients will be randomly assigned to either the drug or placebo group in equal numbers.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MN-001Experimental Treatment1 Intervention
Group II: MN-001 PlaceboPlacebo Group1 Intervention
The placebo comparator is a tablet identical in appearance to MN-001.
MN-001 is already approved in European Union, Canada for the following indications:
🇪🇺 Approved in European Union as Tipelukast for:
- Scleroderma
- Systemic sclerosis
🇨🇦 Approved in Canada as Tipelukast for:
- Scleroderma
- Systemic sclerosis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Jubilee Clinical Research, Inc.Las Vegas, NV
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Who Is Running the Clinical Trial?
MediciNovaLead Sponsor
References
[Diisopropylamine dichloroacetate in the treatment of nonalcoholic fatty liver disease: a multicenter random double-blind controlled trial]. [2005]To investigate the efficacy and safety of diisopropylamine dichloroacetate in the treatment of nonalcoholic fatty liver diseases (NAFLD).
Glucagon-Like Peptide-1 Receptor Agonists for Treatment of Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis: An Updated Meta-Analysis of Randomized Controlled Trials. [2021]To assess the efficacy of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) for treatment of nonalcoholic fatty liver disease (NAFLD) or steatohepatitis (NASH), we performed a systematic review and meta-analysis of randomized controlled trials (RCTs). Three large electronic databases were systematically searched (up to 15 December 2020) to identify placebo-controlled or active-controlled RCTs using different GLP-1 RAs. We included eleven placebo-controlled or active-controlled phase-2 RCTs (involving a total of 936 middle-aged individuals) that used liraglutide (n = 6 RCTs), exenatide (n = 3 RCTs), dulaglutide (n = 1 RCT) or semaglutide (n = 1 RCT) to specifically treat NAFLD or NASH, detected by liver biopsy (n = 2 RCTs) or imaging techniques (n = 9 RCTs). Compared to placebo or reference therapy, treatment with GLP-1 RAs for a median of 26 weeks was associated with significant reductions in the absolute percentage of liver fat content on magnetic resonance-based techniques (pooled weighted mean difference: -3.92%, 95% confidence intervals (CI) -6.27% to -1.56%) and serum liver enzyme levels, as well as with greater histological resolution of NASH without worsening of liver fibrosis (pooled random-effects odds ratio 4.06, 95% CI 2.52-6.55; for liraglutide and semaglutide only). In conclusion, treatment with GLP-1 RAs (mostly liraglutide and semaglutide) is a promising treatment option for NAFLD or NASH that warrants further investigation.
Non-Alcoholic Fatty Liver Disease Treatment in Patients with Type 2 Diabetes Mellitus; New Kids on the Block. [2020]Non-alcoholic fatty liver disease (NAFLD), affecting over 25% of the general population worldwide, is characterized by a spectrum of clinical and histological manifestations ranging from simple steatosis (>5% hepatic fat accumulation without inflammation) to non-alcoholic steatohepatitis (NASH) which is characterized by inflammation, and finally fibrosis, often leading to liver cirrhosis, and hepatocellular carcinoma. Up to 70% of patients with type 2 diabetes mellitus (T2DM) have NAFLD, and diabetics have much higher rates of NASH compared with the general non-diabetic population.
The leukotriene receptor antagonist montelukast in the treatment of non-alcoholic steatohepatitis: A proof-of-concept, randomized, double-blind, placebo-controlled trial. [2021]Non-alcoholic fatty liver disease (NAFLD) is associated with fat accumulation in the liver which can progress into non-alcoholic steatohepatitis (NASH). There is no specific treatment strategy for NASH. In this context, this study aimed at evaluating the efficacy and safety of montelukast in the treatment of patients with NASH. In this randomized double-blind placebo-controlled study, 52 overweight/obese patients with NASH were randomized into group 1 (n = 26) which received montelukast 10 mg tablets once daily and group 2 (n = 26) which received placebo tablets once daily for 12 weeks. The fibro-scan was used to assess liver stiffness as a primary outcome at baseline and 12 weeks post-treatment. Furthermore, patients were assessed for biochemical analysis of liver aminotransferases, metabolic parameters, TNF-α, 8-hydroxy-2'-deoxyguanosine (8-OHdG), liver fibrosis biomarkers including hyaluronic acid (HA) and transforming growth factor beta-1 (TGF-β1). Beck depression inventory questionnaire was used to report depressive symptoms. Data were statistically analyzed by paired and unpaired student's t-test, and Chi-square test. A total number of 44 patients completed the study. The two groups were statistically similar at baseline. After treatment and as compared to baseline data and placebo, montelukast showed a statistically significant improvement in liver stiffness, liver enzymes, metabolic parameters (except LDL-C), TNF-α, 8-OHdG, and liver fibrosis biomarkers (HA and TGF-β1). Furthermore, montelukast was well tolerated and didn't provoke depression. In this proof-of-concept study, treatment with montelukast may represent a promising therapeutic strategy for patients with non-alcoholic steatohepatitis secondary to its efficacy and safety. Clinicaltrial.gov ID: NCT04080947.
Pharmacotherapy for Non-Alcoholic Fatty Liver Disease: Emerging Targets and Drug Candidates. [2023]Non-alcoholic fatty liver disease (NAFLD), or metabolic (dysfunction)-associated fatty liver disease (MAFLD), is characterized by high global incidence and prevalence, a tight association with common metabolic comorbidities, and a substantial risk of progression and associated mortality. Despite the increasingly high medical and socioeconomic burden of NAFLD, the lack of approved pharmacotherapy regimens remains an unsolved issue. In this paper, we aimed to provide an update on the rapidly changing therapeutic landscape and highlight the major novel approaches to the treatment of this disease. In addition to describing the biomolecules and pathways identified as upcoming pharmacological targets for NAFLD, we reviewed the current status of drug discovery and development pipeline with a special focus on recent evidence from clinical trials.
Non-alcoholic fatty liver disease: a multicentre clinical study by the Italian Association for the Study of the Liver. [2015]To define the characteristics of the Italian patient presenting non-alcoholic fatty liver disease.
Which treatment for nonalcoholic fatty liver disease? [2019]Subjects with nonalcoholic fatty liver disease are at risk of progressive liver failure. Lifestyle changes including weight-loss strategies and increased physical activity remain the first-line approach, but a few pharmacological treatments have also been successfully tested. Several drugs improve biochemistry, only a few improve histology; in all cases, the results were not sustained after treatment stop. Pharmacological treatment is not so far indicated outside controlled clinical trials with histological outcomes.
A clinical and biochemical profile of biopsy-proven non-alcoholic Fatty liver disease subjects. [2022]To describe clinical and biochemical features of patients with biopsy-proven non-alcoholic fatty liver disease (NAFLD).
Safety, Tolerability, and Biologic Activity of AXA1125 and AXA1957 in Subjects With Nonalcoholic Fatty Liver Disease. [2023]AXA1125 and AXA1957 are novel, orally administered endogenous metabolic modulator compositions, specifically designed to simultaneously support multiple metabolic and fibroinflammatory pathways associated with nonalcoholic fatty liver disease (NAFLD). This study assessed safety, tolerability, and biologic activity of AXA1125 and AXA1957 in NAFLD.