Status:
COMPLETED
Study of Changes in Hepatic Fat Following Administration of MK-4074 and Pioglitazone Hydrochloride (MK-4074-008)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Non-alcoholic Fatty Liver Disease
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
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 hypothesi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 26 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01431521
Start Date
October 26 2011
End Date
October 1 2012
Last Update
September 10 2018
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