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A Double-blind Study to Assess 2 Doses of an Investigational Product for 16 Weeks in Participants With Non-alcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus

Last updated on November 15, 2019

FOR MORE INFORMATION
Study Location
Horizon Clinical Research Associates, PLLC
Gilbert, Arizona, 85295 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-alcoholic 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

- Males, or females of nonchildbearing potential

- 18 to 70 years of age

- Type 2 Diabetes Mellitus

- Liver fat >/=8% by MRI-PDFF

- On stable dose of metformin monotherapy for at least 2 months (at a dose of at least
500 mg daily)

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

- History of other liver disease

- Unable to have an MRI performed

- Significant weight loss in the previous month and/or participant in current weight
loss program

- History of diabetic complications with end-organ damage

NCT03969719
Pfizer
Recruiting
A Double-blind Study to Assess 2 Doses of an Investigational Product for 16 Weeks in Participants With Non-alcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus

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[email protected]

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Non-alcoholic Steatohepatitis, Non-alcoholic Fatty Liver Disease
NCT03513588
All Genders
18+
Years
Multiple Sites
Descriptive Information
Brief Title  ICMJE A Double-blind Study to Assess 2 Doses of an Investigational Product for 16 Weeks in Participants With Non-alcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus
Official Title  ICMJE A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 3-ARM, PARALLEL GROUP STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED DAILY FOR 16 WEEKS IN ADULTS WITH NON-ALCOHOLIC FATTY LIVER DISEASE AND TYPE 2 DIABETES MELLITUS ON METFORMIN
Brief SummaryThis is a double-blind, placebo-controlled study in adults with non-alcoholic steatohepatitis and Type 2 Diabetes Mellitis on stable dose of metformin monotherapy. Participants will be treated for 16 weeks with placebo or 1 of 2 doses of investigational product to determine the effect on liver fat, HbA1c, safety, tolerability and pharmacodynamics.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Non-alcoholic Steatohepatitis
Intervention  ICMJE
  • Drug: Placebo
    Placebo
  • Drug: PF-06835919
    150 mg once daily
  • Drug: PF-06835919
    300 mg once daily
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Palacebo
    Intervention: Drug: Placebo
  • Experimental: Low Dose
    150 mg
    Intervention: Drug: PF-06835919
  • Experimental: High Dose
    300 mg
    Intervention: Drug: PF-06835919
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 28, 2019)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 10, 2021
Estimated Primary Completion DateFebruary 10, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males, or females of nonchildbearing potential
  • 18 to 70 years of age
  • Type 2 Diabetes Mellitus
  • Liver fat >/=8% by MRI-PDFF
  • On stable dose of metformin monotherapy for at least 2 months (at a dose of at least 500 mg daily)

Exclusion Criteria:

  • History of other liver disease
  • Unable to have an MRI performed
  • Significant weight loss in the previous month and/or participant in current weight loss program
  • History of diabetic complications with end-organ damage
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03969719
Other Study ID Numbers  ICMJE C1061011
DOSE RESPONSE IN PATIENTS ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
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/da....
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2019

ICMJE     Data element required by the

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

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