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Study of Changes in Hepatic Fat Following Administration of MK-4074 and Pioglitazone Hydrochloride (MK-4074-008) | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study of Changes in Hepatic Fat Following Administration of MK-4074 and Pioglitazone Hydrochloride (MK-4074-008)

An Exploratory Study to Evaluate Changes in Hepatic Fat Following Multiple-Dose Administration of MK-4074 and Pioglitazone Hydrochloride

NCT01431521•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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 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).

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

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)
+6 more criteria

Key Dates

Start Date

October 26, 2011

Primary Completion Date

September 18, 2012

Completion Date

October 1, 2012

Last Updated

September 10, 2018

Enrollment

ACTUAL participants

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

MK-4074 200 mg

DRUG

Placebo for MK-4074

DRUG

Pioglitazone hydrochloride 30 mg

DRUG

Placebo for pioglitazone hydrochloride

DRUG

Identification of Liver Fibrosis Biomarkers

NCT06819917

Non-alcoholic Fatty LiverNon-Alcoholic Fatty Liver Disease+1 more

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RECRUITINGPHASE3

A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH

NCT07221227

Non-alcoholic Fatty Liver Disease

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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: September 10, 2018Data 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.

View ClinicalTrials.gov Terms and Conditions

Study of Changes in Hepatic Fat Following Administration of MK-4074 and Pioglitazone Hydrochloride (MK-4074-008)

Inclusion Criteria

Exclusion Criteria

Identification of Liver Fibrosis Biomarkers

A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH

Non-Invasive Diagnostic Tests for MASLD in Pediatric Population

Accuracy of Imaging Techniques in Diagnosing Steatohepatitis and Fibrosis in NAFLD Patients

Nonalcoholic Steatohepatitis in Chinese Children

OneSTOP (One-Stop Telehealth Obesity Program) for Multidisciplinary Weight Management and Related Comorbidities