2-Week Study In People With Nonalcoholic Fatty Liver Disease

Pfizer48 enrolled

Overview

2-week study in people with nonalcoholic fatty liver disease. Study drug at 1 of 2 doses, or placebo, will be given for 14 days. Blood samples, heart monitoring, vital signs, and imaging procedures will be performed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Non-alcoholic Steatohepatitis Non-alcoholic Fatty Liver Disease

Interventions

PlaceboDRUG

tablet, 0 mg, 14 days, every 12 hours

PF-06865571DRUG

tablet, 50 mg, 14 days, every 12 hours

PF-06865571DRUG

tablet, 300 mg, 14 days, every 12 hours

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * controlled attenuation parameter greater than or equal to 260 dB/m via FibroScan * liver fat greater than or equal to 6% via MRI Exclusion Criteria: * Chronic liver disease * Type 2 diabetes requiring drug treatment * Unable to undergo MRI * History of heart attack or stroke

Locations (6)

Anaheim Clinical Trials, LLC

Anaheim, California, United States

New Haven Clinical Research Unit

New Haven, Connecticut, United States

Qps-Mra, Llc

South Miami, Florida, United States

PPD Development, LP

Las Vegas, Nevada, United States

Outcomes

Primary Outcomes

Relative Change From Baseline in Whole Liver Fat at Day 15 as Assessed by Magnetic Resonance Imaging (MRI) - Proton Density Fat Fraction (PDFF)

MRI-PDFF is an established method that enables quantification of fat content in the liver. The value of whole liver fat as assessed by MRI-PDFF is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level.

Time frame: Baseline (Day 1), Day 15

Secondary Outcomes

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity on or after the first dose of investigational product administration. AEs included both SAEs and non-serious AEs.

Time frame: From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days)

Number of Participants With Laboratory Test Abnormalities

Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes); chemistry (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, protein, albumin, urea nitrogen, creatinine, urate, sodium, potassium, calcium, chloride, bicarbonate); urinalysis (urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, urine erythrocytes, urine leukocytes, hyaline casts); biomarker (total cholesterol, low-density and high-density lipoprotein cholesterol, triglycerides, fasting glucose). Participants with any of the laboratory test abnormalities were counted.

Data from ClinicalTrials.gov

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Number of Participants With Electrocardiogram (ECG) Abnormalities

ECG categorical summarization criteria: 1) QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): \>=140 milliseconds (msec), \>=50% change from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): \>=300 msec, \>=25% change when baseline is \> 200 msec or \>=50% change when baseline is less than or equal to (\<=) 200 msec; 3) QTcF interval (heart rate corrected QT \[time between the start of the ECG Q wave and the end of the T wave in the heart's electrical cycle\] using Fridericia's formula): absolute value of \>450 to 480 msec, \>480 to 500 msec, \>500 msec; a change from baseline of \>30 to 60 msec or \>60 msec.

Time frame: From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days)