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6-week Safety and PD Study in Adults With NAFLD

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NCT03256526

Last updated on October 10, 2018
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FOR MORE INFORMATION
Study Location
National Research Institute
Los Angeles, California, 90057 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

NCT03256526
Pfizer
Completed
6-week Safety and PD Study in Adults With NAFLD

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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6-week Safety and PD Study in Adults With NAFLD
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
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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Non-alcoholic Fatty Liver Disease
  • Drug: Placebo
    0 mg
  • Drug: PF-06835919 Low Dose
    75 mg once daily
  • Drug: PF-06835919 High Dose
    300 mg once daily
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
51
June 13, 2018
June 13, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT03256526
C1061003
No
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
November 2017

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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Contact

[email protected]



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