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

NCT03969719

Last updated date
Study Location
Nebraska Medicine
Omaha, Nebraska, 98198, United States

Study Website

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

By phone

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 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

NEED INFO?

For Patients: Please visit the study website for more information

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Non-alcoholic SteatohepatitisA 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
NCT03969719
  1. Omaha, Nebraska
  2. Gilbert, Arizona
  3. Gilbert, Arizona
  4. Phoenix, Arizona
  5. Phoenix, Arizona
  6. Tempe, Arizona
  7. Anaheim, California
  8. Canoga Park, California
  9. Chula Vista, California
  10. Coronado, California
  11. Coronado, California
  12. Harbor City, California
  13. Harbor City, California
  14. La Mesa, California
  15. Lincoln, California
  16. Los Angeles, California
  17. Northridge, California
  18. Pasadena, California
  19. Rialto, California
  20. Sacramento, California
  21. San Diego, California
  22. San Diego, California
  23. San Diego, California
  24. Santa Ana, California
  25. Spring Valley, California
  26. Tarzana, California
  27. Torrance, California
  28. Torrance, California
  29. Tustin, California
  30. Atlantis, Florida
  31. Daytona Beach, Florida
  32. Doral, Florida
  33. Hallandale Beach, Florida
  34. Jacksonville, Florida
  35. Lake City, Florida
  36. Miami Lakes, Florida
  37. Miami, Florida
  38. Miami, Florida
  39. Miami, Florida
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  47. Miami, Florida
  48. Palm Harbor, Florida
  49. Palm Harbor, Florida
  50. Palm Springs, Florida
  51. Palm Springs, Florida
  52. Port Orange, Florida
  53. South Miami, Florida
  54. Lawrenceville, Georgia
  55. Honolulu, Hawaii
  56. Wichita, Kansas
  57. Flint, Michigan
  58. Omaha, Nebraska
  59. Las Vegas, Nevada
  60. Las Vegas, Nevada
  61. Las Vegas, Nevada
  62. Las Vegas, Nevada
  63. Garden City, New York
  64. Manhasset, New York
  65. Wilmington, North Carolina
  66. Winston-Salem, North Carolina
  67. Winston-Salem, North Carolina
  68. Cincinnati, Ohio
  69. Cincinnati, Ohio
  70. Marion, Ohio
  71. Philadelphia, Pennsylvania
  72. Philadelphia, Pennsylvania
  73. Dallas, Texas
  74. Dallas, Texas
  75. Dallas, Texas
  76. Dallas, Texas
  77. Dallas, Texas
  78. Dallas, Texas
  79. Houston, Texas
  80. Houston, Texas
  81. Houston, Texas
  82. Houston, Texas
  83. Houston, Texas
  84. Houston, Texas
  85. Houston, Texas
  86. Live Oak, Texas
  87. San Antonio, Texas
  88. San Antonio, Texas
  89. San Antonio, Texas
  90. San Antonio, Texas
  91. Schertz, Texas
  92. Richmond, Virginia
  93. Richmond, Virginia
  94. Richmond, Virginia
  95. Richmond, Virginia
  96. Richmond, Virginia
  97. Salem, Virginia
  98. Seattle, Washington
  99. Seattle, Washington
  100. Seattle, Washington
  101. Victoria, British Columbia
  102. Victoria, British Columbia
  103. Halifax, Nova Scotia
  104. Halifax, Nova Scotia
  105. Halifax, Nova Scotia
  106. Brampton, Ontario
  107. London, Ontario
  108. Mississauga, Ontario
  109. Sarnia, Ontario
  110. Toronto, Ontario
  111. Toronto, Ontario
  112. Chicoutimi, Quebec
  113. Chicoutimi, Quebec
  114. Montreal, Quebec
  115. Montreal, Quebec
  116. Montreal, Quebec
  117. Montreal, Quebec
  118. Montreal, Quebec
  119. Montreal, Quebec
  120. Quebec,
  121. Quebec,
  122. Quebec,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 Summary This 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 Description Not 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 April 8, 2021
Estimated Primary Completion Date April 8, 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 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 September 2020

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