6-week Safety and PD Study in Adults With NAFLD
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
1 other identifier
interventional
53
1 country
9
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2017
Shorter than P25 for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2017
CompletedFirst Posted
Study publicly available on registry
August 22, 2017
CompletedStudy Start
First participant enrolled
September 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2018
CompletedResults Posted
Study results publicly available
April 4, 2019
CompletedApril 4, 2019
March 1, 2019
6 months
August 16, 2017
March 12, 2019
March 12, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Baseline up to Day 77 (28-35 days post last dose)
Number of Participants With Post-dose Vital Signs Data Meeting Categorical Criteria
Baseline up to Day 56 (Week 8)
Number of Participants With Post-dose ECG Data Meeting Categorical Criteria
Baseline up to Day 56 (Week 8)
Number of Participants With Laboratory Abnormalities
Baseline up to Day 56 (Week 8)
Study Arms (3)
Placebo
PLACEBO COMPARATORPF-06835919 Low Dose
EXPERIMENTAL75 mg once daily
PF-06835919 High Dose
EXPERIMENTAL300 mg once daily
Interventions
Eligibility Criteria
You may qualify if:
- BMI at least 28 kg/m2
- Type 2 diabetes and/or metabolic syndrome
You may not qualify if:
- Liver disease
- Type 1 diabetes
- Recent heart attack or stroke
- Inability to have an MRI scan
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (9)
National Research Institute
Los Angeles, California, 90057, United States
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
Stand-Up MRI of Miami
Miami, Florida, 33145, United States
Avail Clinical Research, LLC
Orange City, Florida, 32763, United States
Qps-Mra, Llc
South Miami, Florida, 33143, United States
Sterling Research Group, Ltd.
Cincinnati, Ohio, 45219, United States
WR-ClinSearch LLC
Chattanooga, Tennessee, 37421, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
National Clinical Research, Inc
Richmond, Virginia, 23294, United States
Related Publications (1)
Kazierad DJ, Chidsey K, Somayaji VR, Bergman AJ, Birnbaum MJ, Calle RA. Inhibition of ketohexokinase in adults with NAFLD reduces liver fat and inflammatory markers: A randomized phase 2 trial. Med. 2021 Jul 9;2(7):800-813.e3. doi: 10.1016/j.medj.2021.04.007. Epub 2021 Apr 27.
PMID: 35590219DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2017
First Posted
August 22, 2017
Study Start
September 27, 2017
Primary Completion
March 30, 2018
Study Completion
April 27, 2018
Last Updated
April 4, 2019
Results First Posted
April 4, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will share
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.