6-week Safety and PD Study in Adults With NAFLD

Pfizer53 enrolled

Overview

IN THIS PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, 3 ARM, PARALLEL- GROUP STUDY, SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED ONCE DAILY FOR 6 WEEKS WILL BE ASSESSED IN ADULTS WITH NONALCOHOLIC FATTY LIVER DISEASE

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

PlaceboDRUG

0 mg

PF-06835919 Low DoseDRUG

75 mg once daily

PF-06835919 High DoseDRUG

300 mg once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * BMI at least 28 kg/m2 * Type 2 diabetes and/or metabolic syndrome Exclusion Criteria: * Liver disease * Type 1 diabetes * Recent heart attack or stroke * Inability to have an MRI scan

Locations (9)

National Research Institute

Los Angeles, California, United States

Avail Clinical Research, LLC

DeLand, Florida, United States

Stand-Up MRI of Miami

Miami, Florida, United States

Avail Clinical Research, LLC

Outcomes

Primary Outcomes

Percent Change From Baseline in Whole Liver Fat at Week 6

The percent change from baseline in whole liver fat at Week 6 was assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF). MRI-PDFF generates measures of the fraction of mobile protons in the liver attributable to fat content and provides whole liver coverage so that fat content can be assessed across 8 Couinaud liver segments. Whole liver PDFF was calculated as follows: Whole Liver PDFF= PDFFs for (Segment I+Segment II+Segment III+Segment IVa+Segment IVb+Segment V+Segment VI+Segment+VII+Segment VIII) / (number of segments assessed). The same segments were to be used at both baseline and post-baseline time points in the calculation of whole liver PDFF to derive the percent change from baseline. The values of whole liver PDFF ranges from 0 to 100 and higher values represent higher liver fat.

Time frame: Baseline and Week 6

Secondary Outcomes

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

All-causality adverse events (AEs) were any untoward medical occurrence in a study participant who administered a product or medical device, the event need not necessarily have a causal relationship with the treatment or usage. Treatment-related AEs were any untoward medical occurrence in a study participant who administered a product or medical device, the event needed to have a causal relationship with the treatment or usage. A TEAE was defined as any event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments.

Time frame: Baseline up to Day 77 (28-35 days post last dose)

Number of Participants With Post-dose Vital Signs Data Meeting Categorical Criteria

The vital sign categorical criteria included: Sitting DBP (diastolic blood pressure) millimeter of mercury (mmHg) Change \>= 20 mmHg increase Sitting SBP (systolic blood pressure) (mmHg) Change \>= 30 mmHg increase Sitting DBP (mmHg) Change \>= 20 mmHg decrease Sitting SBP (mmHg) Change \>= 30 mmHg decrease Sitting DBP (mmHg) Value \< 50 mmHg Sitting Pulse Rate (bpm) Value \< 40 bpm or Value \> 120 bpm Sitting SBP (mmHg) Value \< 90 mmHg

Data from ClinicalTrials.gov

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