6-week Safety and PD Study in Adults With NAFLD

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NCT03256526

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Study Location
National Research Institute
Los Angeles, California, 90057, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-alcoholic Fatty Liver Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- BMI at least 28 kg/m2

- Type 2 diabetes and/or metabolic syndrome

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


- Liver disease


- Type 1 diabetes


- Recent heart attack or stroke


- Inability to have an MRI scan

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Non-alcoholic Fatty Liver Disease6-week Safety and PD Study in Adults With NAFLD
NCT03256526
  1. Los Angeles, California
  2. DeLand, Florida
  3. Miami, Florida
  4. Orange City, Florida
  5. South Miami, Florida
  6. Cincinnati, Ohio
  7. Chattanooga, Tennessee
  8. San Antonio, Texas
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Advanced Information
Descriptive Information
Brief Title  ICMJE 6-week Safety and PD Study in Adults With NAFLD
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Non-alcoholic Fatty Liver Disease
Intervention  ICMJE
  • Drug: Placebo
    0 mg
  • Drug: PF-06835919 Low Dose
    75 mg once daily
  • Drug: PF-06835919 High Dose
    300 mg once daily
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: PF-06835919 Low Dose
    75 mg once daily
    Intervention: Drug: PF-06835919 Low Dose
  • Experimental: PF-06835919 High Dose
    300 mg once daily
    Intervention: Drug: PF-06835919 High Dose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 8, 2018)		53
Original Estimated Enrollment  ICMJE
 (submitted: August 18, 2017)		51
Actual Study Completion Date  ICMJE April 27, 2018
Actual Primary Completion Date March 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI at least 28 kg/m2
  • Type 2 diabetes and/or metabolic syndrome

Exclusion Criteria:

  • Liver disease
  • Type 1 diabetes
  • Recent heart attack or stroke
  • Inability to have an MRI scan
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03256526
Other Study ID Numbers  ICMJE C1061003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP