2-Week Study In People With Nonalcoholic Fatty Liver Disease
A PHASE 1B, RANDOMIZED, DOUBLE-BLIND (SPONSOR-OPEN), PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACODYNAMICS AND PHARMACOKINETICS OF MULTIPLE ORAL DOSES OF PF- 06865571 FOR 2 WEEKS IN ADULTS WITH NONALCOHOLIC FATTY LIVER DISEASE
1 other identifier
interventional
48
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2018
6 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
April 19, 2018
CompletedFirst Posted
Study publicly available on registry
May 1, 2018
CompletedStudy Start
First participant enrolled
June 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2019
CompletedResults Posted
Study results publicly available
March 13, 2020
CompletedMarch 13, 2020
February 1, 2020
9 months
April 19, 2018
February 28, 2020
February 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline (Day 1), Day 15
Secondary Outcomes (10)
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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
From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days)
Number of Participants With Vital Sign Abnormalities
From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days)
Number of Participants With Electrocardiogram (ECG) Abnormalities
From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days)
Maximum Plasma Concentration (Cmax) For PF-06865571
Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose
- +5 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORPF-06865571 100 mg
EXPERIMENTALPF-06865571 600 mg
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- controlled attenuation parameter greater than or equal to 260 dB/m via FibroScan
- liver fat greater than or equal to 6% via MRI
You may not qualify if:
- Chronic liver disease
- Type 2 diabetes requiring drug treatment
- Unable to undergo MRI
- History of heart attack or stroke
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (6)
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
New Haven Clinical Research Unit
New Haven, Connecticut, 06511, United States
Qps-Mra, Llc
South Miami, Florida, 33143, United States
PPD Development, LP
Las Vegas, Nevada, 89113, United States
High Point Clinical Trials Center
High Point, North Carolina, 27265, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
Related Publications (1)
Amin NB, Saxena AR, Somayaji V, Dullea R. Inhibition of Diacylglycerol Acyltransferase 2 Versus Diacylglycerol Acyltransferase 1: Potential Therapeutic Implications of Pharmacology. Clin Ther. 2023 Jan;45(1):55-70. doi: 10.1016/j.clinthera.2022.12.008. Epub 2023 Jan 21.
PMID: 36690550DERIVED
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 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2018
First Posted
May 1, 2018
Study Start
June 21, 2018
Primary Completion
March 8, 2019
Study Completion
April 4, 2019
Last Updated
March 13, 2020
Results First Posted
March 13, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not 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.