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NCT03256526 · ClinicalTrials.gov registry record · Phase 2
6-week Safety and PD Study in Adults With NAFLD
A Phase 2 study of Non-alcoholic Fatty Liver Disease, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
- 9
- Study locations
NCT03256526: Completed Phase 2 study of Non-alcoholic Fatty Liver Disease, sponsored by Pfizer.
NCT03256526 is a Phase 2 study of Non-alcoholic Fatty Liver Disease that has completed, run by Pfizer. The registered enrollment target is 53 participants, below the 176-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (70% lower). The trial reports 9 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03256526, a Phase 2 study of Non-alcoholic Fatty Liver Disease, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
- 9
- Study locations
Study 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
Primary Outcome
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+Segmen
Conditions Studied
Interventions
- DRUG Placebo
- DRUG PF-06835919 Low Dose
- DRUG PF-06835919 High Dose
Study Locations (9)
Florida
- Avail Clinical Research, LLC - DeLand
- Stand-Up MRI of Miami - Miami
- Avail Clinical Research, LLC - Orange City
- Qps-Mra, Llc - South Miami
California
- National Research Institute - Los Angeles
Ohio
- Sterling Research Group, Ltd. - Cincinnati
Tennessee
- WR-ClinSearch LLC - Chattanooga
Texas
- Clinical Trials of Texas, Inc. - San Antonio
Virginia
- National Clinical Research, Inc - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2017-09-27 |
| Est. Completion | 2018-04-27 |
| Phase | Phase 2 |
What the finished NCT03256526 record still lists
NCT03256526 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 176-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Non-alcoholic Fatty Liver Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03256526 lists 9 locations in 6 states (Florida, California, Ohio).
Frequently Asked Questions
What is clinical trial NCT03256526 about?
NCT03256526 is a clinical study titled "6-week Safety and PD Study in Adults With NAFLD". 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
What is the current status of trial NCT03256526?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2017-09-27. Estimated completion is 2018-04-27.
What conditions does trial NCT03256526 study?
This clinical trial studies the following conditions: Non-alcoholic Fatty Liver Disease.
What interventions are being tested in trial NCT03256526?
The interventions under investigation include: Placebo (DRUG), PF-06835919 Low Dose (DRUG), PF-06835919 High Dose (DRUG).
Who is sponsoring clinical trial NCT03256526?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03256526 being conducted?
This trial has 9 study locations across California, Florida, Ohio, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03256526's enrollment target sits among peer trials
53 33rd of 57 higher than 25 of 57 other Non-alcoholic Fatty Liver Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-alcoholic Fatty Liver Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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