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6-week Safety and PD Study in Adults With NAFLD

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ClinicalTrials.gov Identifier: NCT03256526
Recruitment Status : Completed
First Posted : August 22, 2017
Results First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief 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

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Drug: Placebo Drug: PF-06835919 Low Dose Drug: PF-06835919 High Dose Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : September 27, 2017
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : April 27, 2018


Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
0 mg

Experimental: PF-06835919 Low Dose
75 mg once daily
Drug: PF-06835919 Low Dose
75 mg once daily

Experimental: PF-06835919 High Dose
300 mg once daily
Drug: PF-06835919 High Dose
300 mg once daily




Primary Outcome Measures :
  1. Percent Change From Baseline in Whole Liver Fat at Week 6 [ Time Frame: Baseline and 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.



Secondary Outcome Measures :
  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Baseline up to Day 77 (28-35 days post last dose) ]

    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.


  2. Number of Participants With Post-dose Vital Signs Data Meeting Categorical Criteria [ Time Frame: Baseline up to Day 56 (Week 8) ]

    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


  3. Number of Participants With Post-dose ECG Data Meeting Categorical Criteria [ Time Frame: Baseline up to Day 56 (Week 8) ]

    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


  4. Number of Participants With Laboratory Abnormalities [ Time Frame: Baseline up to Day 56 (Week 8) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03256526


Locations
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United States, California
National Research Institute
Los Angeles, California, United States, 90057
United States, Florida
Avail Clinical Research, LLC
DeLand, Florida, United States, 32720
Stand-Up MRI of Miami
Miami, Florida, United States, 33145
Avail Clinical Research, LLC
Orange City, Florida, United States, 32763
Qps-Mra, Llc
South Miami, Florida, United States, 33143
United States, Ohio
Sterling Research Group, Ltd.
Cincinnati, Ohio, United States, 45219
United States, Tennessee
WR-ClinSearch LLC
Chattanooga, Tennessee, United States, 37421
United States, Texas
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States, 78229
United States, Virginia
National Clinical Research, Inc
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] June 29, 2017
Statistical Analysis Plan  [PDF] November 7, 2017


Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03256526     History of Changes
Other Study ID Numbers: C1061003
First Posted: August 22, 2017    Key Record Dates
Results First Posted: April 4, 2019
Last Update Posted: April 4, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases