Non-alcoholic Fatty Liver Disease Clinical Trial
Official title:
An Exploratory Study to Evaluate Changes in Hepatic Fat Following Multiple-Dose Administration of MK-4074 and Pioglitazone Hydrochloride
Verified date | August 2018 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate changes in liver fat content following multiple oral doses of MK-4074 and Pioglitazone Hydrochloride in adult males and females with fatty liver disease. The primary hypothesis of the study is that a multiple-dose administration of MK-4074 200 mg twice daily for 4 weeks results in a decrease in hepatic fat content with respect to placebo in adult male and female participants with hepatic steatosis (i.e., on order of 50% reduction in hepatic fat with respect to placebo is expected).
Status | Completed |
Enrollment | 31 |
Est. completion date | October 1, 2012 |
Est. primary completion date | September 18, 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Females must be of non-childbearing potential - Body mass index (BMI) =32.0 kg/m^2 - In good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests - No clinically significant abnormality on electrocardiogram - Has documented hepatic fat content =10% within 6 months of enrollment - Maintained stable weight (by history) for at least 4 weeks - Agrees not to initiate a weight loss program and agrees to maintain consistent dietary habits and exercise routines for the duration of the study - Has a rating of 'moderate' or 'severe' steatosis on ultrasound at the prestudy (screening) visit Exclusion Criteria: - Change in weight greater than 4% between prestudy visit and randomization into the study - History of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant - Liver disease other than fatty liver or non-alcoholic steatohepatitis (NASH) - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =3x the upper limit of normal range - Serum triglyceride level >600 mg/dL - History of stroke, chronic seizures, or major neurological disorder - History of clinically significant endocrine, gastrointestinal, cardiovascular (including congestive heart failure), hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases - Had abdominal surgery, gastric bypass, bowel resection, recent liver biopsy, or any other procedure within a minimum of 4 weeks - History of neoplastic disease - Claustrophobia or other contraindication to magnetic resonance imaging (MRI) - Have not washed off agents associated with changes in hepatic fat or used for treatment of Non-alcoholic fatty liver disease (NAFLD) or NASH for a minimum of 3 months prior - Consumes excessive amounts of alcohol, coffee, tea, cola, or other caffeinated beverages - Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks - Significant multiple and/or severe allergies - Intolerance or hypersensitivity to pioglitazone hydrochloride or any inactive ingredients - Regular user of any illicit drugs or has a history of drug (including alcohol) abuse. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Merck Sharp & Dohme Corp. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent Change From Baseline in Hepatic Fat | Hepatic fat content was assessed via magnetic resonance imaging (MRI) prior to first dose administration and following 4 weeks of treatment. Percent change in hepatic fat fraction from baseline was calculated for each of the 9 liver regions separately and then these were averaged to calculate overall percent change from baseline for each participant. | Baseline and Week 4 | |
Primary | Number of Participants Experiencing One or More Adverse Events (AE) | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. | Up to 10 weeks | |
Primary | Number of Participants Who Discontinued Study Drug Due to an AE | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. | Up to 4 weeks | |
Secondary | Percent Change From Baseline in Alanine Transaminase (ALT) | Hepatic steatosis is not uncommonly associated with mild elevations in serum transaminases, specifically ALT, and these elevations may be a marker of more advanced hepatic disease. Serum transaminases were monitored at baseline and once weekly for the duration of the study to permit a better understanding of the time course of potential improvement in hepatic inflammation during the course of this short study. | Baseline and Week 4 | |
Secondary | Percent Change From Baseline Aspartate Transaminase (AST) | Hepatic steatosis is not uncommonly associated with mild elevations in serum transaminases, including AST, and these elevations may be a marker of more advanced hepatic disease. Serum transaminases were monitored at baseline and once weekly for the duration of the study to permit a better understanding of the time course of potential improvement in hepatic inflammation during the course of this short study. | Baseline and Week 4 |
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