Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03248882
Recruitment Status : Completed
First Posted : August 14, 2017
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)

Condition or disease Intervention/treatment Phase
Nonalcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis Drug: Placebo Drug: PF-05221304 Phase 2

Detailed Description:
A Phase 2a, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel Group Study To Evaluate Safety, Tolerability, And Pharmacodynamics Of PF-05221304 Administered Daily For 16-weeks To Adult Subjects With Nonalcoholic Fatty Liver Disease

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 305 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: C1171002 is a randomized, double blind, placebo controlled, 5 arm (placebo, plus 4 active doses of PF 05221304), parallel group study.
Masking: Double (Participant, Investigator)
Masking Description: Double-Blind
Primary Purpose: Treatment
Official Title: A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING, PARALLEL GROUP STUDY TO EVALUATE SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-05221304 ADMINISTERED DAILY FOR 16-WEEKS TO ADULT SUBJECTS WITH NONALCOHOLIC FATTY LIVER DISEASE
Actual Study Start Date : August 22, 2017
Actual Primary Completion Date : February 26, 2019
Actual Study Completion Date : March 27, 2019


Arm Intervention/treatment
Placebo Comparator: Placebo
Double-Blind, PF-05221304-matching Placebo
Drug: Placebo
Placebo

Active Comparator: PF-05221304 - 2 mg
PF-05221304 - 2 mg, once-daily
Drug: PF-05221304
PF-05221304, Experimental Drug

Active Comparator: PF-05221304 - 10 mg
PF-05221304 - 10 mg, once-daily
Drug: PF-05221304
PF-05221304, Experimental Drug

Active Comparator: PF-05221304 - 25 mg
PF-05221304 - 25 mg, once-daily
Drug: PF-05221304
PF-05221304, Experimental Drug

Active Comparator: PF-05221304 - 50 mg
PF-05221304 - 50 mg, once-daily
Drug: PF-05221304
PF-05221304, Experimental Drug




Primary Outcome Measures :
  1. Evaluate Dose-Response for Effect on Liver Fat using MRI-PDFF [ Time Frame: 16-weeks ]
    Percent change from baseline in liver fat, as assessed using MRI-PDFF, at Week 16


Secondary Outcome Measures :
  1. Evaluate Dose-Response for Effect on ALT [ Time Frame: 16-weeks ]
    Percent change from baseline in ALT, at Week 16

  2. Assessment of treatment-emergent adverse events [ Time Frame: Day 1 to Week 20 ]
    Spontaneously reported treatment-emergent adverse events

  3. Assessment of clinical laboratory tests [ Time Frame: Day 1 to Week 20 ]
    Evaluation of safety-related clinical laboratory tests

  4. Assessment of Vital Signs [ Time Frame: Day 1 to Week 20 ]
    Including measurement of Blood Pressure and Pulse rate

  5. Assessment of 12-lead electrocardiograms [ Time Frame: Day 1 to Week 20 ]
    Evaluation of cardiac conduction intervals



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body Mass Index >= 25 kg/m2
  • Body Weight > 50 kg
  • Liver fat (assessed via MRI-PDFF) >= 8%
  • Biopsy-proven NASH - diagnosed in previous 24-months
  • Presumed NASH - per Sponsor's definition
  • NAFLD with minimal inflammation/fibrosis
  • Features of Metabolic Syndrome

Exclusion Criteria:

  • Alcohol-induced steatohepatitis or other forms of chronic liver disease
  • Positive for Hepatitis B, Hepatitis C, or Human Deficiency Virus
  • Severe Renal Impairment
  • Contraindications for MRI

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): NCT03248882


  Show 141 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03248882     History of Changes
Other Study ID Numbers: C1171002
2017-001156-55 ( EudraCT Number )
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
PF-05221304
NAFLD
NASH
features of metabolic syndrome
Dose-Ranging Study

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