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

Last updated on May 24, 2018

FOR MORE INFORMATION
Study Location
Franco Felizarta MD
Bakersfield, California, 93301 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT03248882
Pfizer
Recruiting
Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)

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

  • Nonalcoholic Fatty Liver Disease
  • Nonalcoholic Steatohepatitis
  • Drug: Placebo
    Placebo
  • Drug: PF-05221304
    PF-05221304, Experimental Drug
  • Placebo Comparator: Placebo
    Double-Blind, PF-05221304-matching Placebo
    Intervention: Drug: Placebo
  • Active Comparator: PF-05221304 - 2 mg
    PF-05221304 - 2 mg, once-daily
    Intervention: Drug: PF-05221304
  • Active Comparator: PF-05221304 - 10 mg
    PF-05221304 - 10 mg, once-daily
    Intervention: Drug: PF-05221304
  • Active Comparator: PF-05221304 - 25 mg
    PF-05221304 - 25 mg, once-daily
    Intervention: Drug: PF-05221304
  • Active Comparator: PF-05221304 - 50 mg
    PF-05221304 - 50 mg, once-daily
    Intervention: Drug: PF-05221304
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
360
March 28, 2019
February 28, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Australia,   Canada,   Poland,   United States
 
 
NCT03248882
C1171002
2017-001156-55 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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