6-week Safety and PD Study in Adults With NAFLD

Non-alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03256526
• Other study ID #: C1061003
• Status: Completed
• Phase: Phase 2
• Start date: September 27, 2017
• Est. completion date: April 27, 2018

Study information

• Verified date: March 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: April 27, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• Placebo
0 mg
• PF-06835919 Low Dose
75 mg once daily
• PF-06835919 High Dose
300 mg once daily

Locations

Country	Name	City	State
United States	WR-ClinSearch LLC	Chattanooga	Tennessee
United States	Sterling Research Group, Ltd.	Cincinnati	Ohio
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	National Research Institute	Los Angeles	California
United States	Stand-Up MRI of Miami	Miami	Florida
United States	Avail Clinical Research, LLC	Orange City	Florida
United States	National Clinical Research, Inc	Richmond	Virginia
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Qps-Mra, Llc	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and Week 6
Secondary	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.	Baseline up to Day 77 (28-35 days post last dose)
Secondary	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	Baseline up to Day 56 (Week 8)
Secondary	Number of Participants With Post-dose ECG Data Meeting Categorical Criteria	The ECG categorical criteria included: PR Interval (msec) percent (%)Change >= 25% increase when baseline >200 or >=50% increase when baseline <=200 QRS Interval (msec) %Change >= 50% increase QTcF Interval (Fridericia's Correction) (msec) increase 30 <= Change < 60 or Change >= 60 PR Interval (msec) Value >= 300 QRS Interval (msec) Value >= 140 QTcF Interval (Fridericia's Correction) (msec) 450 <= Value <480 or 480 <=Value <500 or Value >= 500	Baseline up to Day 56 (Week 8)
Secondary	Number of Participants With Laboratory Abnormalities	Below parameters were evaluated for laboratory tests: Hemoglobin, Hematocrit, Erythrocytes, Ery. Mean Copuscular Volume, Ery. Mean Copuscular Hemoglobin, Ery. Mean Corpuscular HGB Concentration, Platelets, Leukocytes, Lymphocytes, Neuprophils, Basophils, Eosinophils, Monocytes, Bilirubin, Direct Biliirubin, Indirect Bilirubin, Aspartate Aminotransferase, Alanine Aminotransferase, Gamma Glutamyl Transferase, Alkaline Phosphatase, Protein, Albumin, Albumin, Blood Urea Nitrogen, Creatinine, Urate, Sodium, Potassium, Chloride, Calcium, Bicarbonate, Glucose-Fasting, pH, Urine Glucose, Ketone, Urine Protein, Urine Hemoglobin, Urobilinogen, Urine Bilirubin, Nitrite, Leukocyte Esterase, Urine Erythocytes, Urine leukocytes, Hyaline Casts, Urine Creatinine.	Baseline up to Day 56 (Week 8)

External Links

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