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Study to Evaluate the Effect of RGMA001 on Patients With Non Alcoholic Fatty Liver Disease (NAFLD) | Clinical Trials | Clareo Health

UNKNOWNNA

Study to Evaluate the Effect of RGMA001 on Patients With Non Alcoholic Fatty Liver Disease (NAFLD)

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of RGMA001 on Patients With Non Alcoholic Fatty Liver Disease (NAFLD).

NCT01511523•Biovil Research Group, LLC

View on ClinicalTrials.gov

Summary

A research study of a compound containing vitamin E, silymarin and carnitine, three over the counter supplements. The investigators hope to learn if the new supplement can safely and successfully treat fatty liver disease or Non Alcoholic Fatty Liver Disease (NAFLD).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male and female patients age 18 years and older.
•2. A clinical or histologic or radiographic diagnosis of NAFLD.
•3. Abnormities above normal range in hepatic function testing consisting of panels containing ALT, AST, AP, Total bilirubin and albumin.
•4. Negative urine pregnancy test (for females of childbearing potential) collected at screening followed by another negative serum pregnancy test collected within 24 hours prior to the first dose of study drug.
•5. Female patients of childbearing potential must be on adequate birth control.
•6. Willingness to give written informed consent and willingness to participate in and comply with the study requirements.

Exclusion Criteria

•1. History of having received any investigational drug ≤ 3 months prior to the first dose of study drug or the expectation that such drugs will be used during the study. Patients enrolled in this study cannot be enrolled in another study for either research, diagnostic or treatment purposes.
•2. Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, or anti-HIV Ab.
•3. History or other evidence of a medical condition associated with chronic liver disease other than NAFLD (e.g., hemochromatosis, viral or autoimmune hepatitis, Wilson's disease, α1-antitrypsin deficiency, alcoholic liver disease, and/or toxin exposure).
•4. Females who are pregnant or breast feeding.
•5. Platelet count \< 90 x 103 / µL (\< 90 x 109 /L) at screening.
•6. Hemoglobin (Hgb) concentration \< 12 g/dL (\< 120 g/L) in females or \< 13 g/dL (\< 30 g/L) in males at screening.
•7. Any patient with a baseline increased risk for anemia (e.g., thalassemia, sickle cell anemia, spherocytosis, history of gastrointestinal bleeding) or for whom anemia would be medically problematic.
•8. Patients with history of severe psychiatric disease, including psychosis and/or severe depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease must have a psychiatric evaluation at screening to ensure the patient is now stable and the patient must agree to have continued monitoring by a mental health specialist at least every 4 weeks during the study.
•9. History of immunologically mediated disease \[(e.g., vasculitis, cryoglobulinemia, inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis (defined as affecting \> 10% of the body, where the palm of one hand equals 1%, or if the hands and feet are affected), rheumatoid arthritis requiring more than intermittent nonsteroidal anti-inflammatory medications for management, etc.
•10. Patients with evidence of decompensated liver disease including but not limited to ascites, esophageal varices, and hepatic encephalopathy.
+16 more criteria

Locations (1)

Cumberland Research Associates, LLC

Fayetteville, North Carolina, United States

Key Dates

Start Date

January 1, 2012

Primary Completion Date

October 1, 2012

Completion Date

October 1, 2012

Last Updated

March 16, 2012

Enrollment

ESTIMATED participants

Conditions

Non Alcoholic Fatty Liver Disease

Interventions

RGMA001

DIETARY_SUPPLEMENT

Sugar Pill

DIETARY_SUPPLEMENT

Efficacy and Safety of Pemafibrate for Nonalcoholic Fatty Liver Disease

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Non Alcoholic Fatty Liver Disease

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COMPLETEDPHASE2

Comparison of Effectiveness of Obeticholic Acid With Vitamin E in Patients of Non-alcoholic Fatty Liver Disease

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Non Alcoholic Fatty Liver Disease

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UNKNOWNNA

Prevention and Reversion of NAFLD in Obese Patients With Metabolic Syndrome by Mediterranean Diet and Physical Activity

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Evaluate the Effect of RGMA001 on Patients With Non Alcoholic Fatty Liver Disease (NAFLD)

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety of Pemafibrate for Nonalcoholic Fatty Liver Disease

Comparison of Effectiveness of Obeticholic Acid With Vitamin E in Patients of Non-alcoholic Fatty Liver Disease

Prevention and Reversion of NAFLD in Obese Patients With Metabolic Syndrome by Mediterranean Diet and Physical Activity

Non Alcoholic Fatty Liver Disease: Nutritional Epidemiology and Lifestyle Medicine

"Preventing Cardiovascular Ischemic Events and Arresting Their Consequences in Type 2 Diabetic Population

Genetics of Fatty Liver Disease in Children