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
Clinical Research Consortium an AMR company
Tempe, Arizona, 85281, 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

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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. Tempe, Arizona
  2. Las Vegas, Nevada
  3. Gilbert, Arizona
  4. Gilbert, Arizona
  5. Anaheim, California
  6. Canoga Park, California
  7. Chula Vista, California
  8. Coronado, California
  9. Coronado, California
  10. Harbor City, California
  11. Harbor City, California
  12. La Mesa, California
  13. Lincoln, California
  14. Los Angeles, California
  15. Northridge, California
  16. Pasadena, California
  17. Rialto, California
  18. Sacramento, California
  19. San Diego, California
  20. San Diego, California
  21. San Diego, California
  22. Santa Ana, California
  23. Spring Valley, California
  24. Tarzana, California
  25. Tustin, California
  26. Atlantis, Florida
  27. Doral, Florida
  28. Hallandale Beach, Florida
  29. Jacksonville, Florida
  30. Lake City, Florida
  31. Miami Lakes, Florida
  32. Miami, Florida
  33. Miami, Florida
  34. Miami, Florida
  35. Miami, Florida
  36. Miami, Florida
  37. Miami, Florida
  38. Miami, Florida
  39. Miami, Florida
  40. Miami, Florida
  41. Miami, Florida
  42. Miami, Florida
  43. Palm Harbor, Florida
  44. Palm Harbor, Florida
  45. Palm Springs, Florida
  46. Palm Springs, Florida
  47. South Miami, Florida
  48. Lawrenceville, Georgia
  49. Honolulu, Hawaii
  50. Wichita, Kansas
  51. Flint, Michigan
  52. Omaha, Nebraska
  53. Omaha, Nebraska
  54. Las Vegas, Nevada
  55. Las Vegas, Nevada
  56. Las Vegas, Nevada
  57. Las Vegas, Nevada
  58. Garden City, New York
  59. Manhasset, New York
  60. Wilmington, North Carolina
  61. Winston-Salem, North Carolina
  62. Winston-Salem, North Carolina
  63. Cincinnati, Ohio
  64. Cincinnati, Ohio
  65. Marion, Ohio
  66. Philadelphia, Pennsylvania
  67. Philadelphia, Pennsylvania
  68. Dallas, Texas
  69. Dallas, Texas
  70. Dallas, Texas
  71. Dallas, Texas
  72. Houston, Texas
  73. Houston, Texas
  74. Houston, Texas
  75. Houston, Texas
  76. Houston, Texas
  77. Houston, Texas
  78. Live Oak, Texas
  79. San Antonio, Texas
  80. San Antonio, Texas
  81. Schertz, Texas
  82. Richmond, Virginia
  83. Richmond, Virginia
  84. Richmond, Virginia
  85. Salem, Virginia
  86. Seattle, Washington
  87. Seattle, Washington
  88. Seattle, Washington
  89. Victoria, British Columbia
  90. Victoria, British Columbia
  91. Halifax, Nova Scotia
  92. Halifax, Nova Scotia
  93. Halifax, Nova Scotia
  94. Brampton, Ontario
  95. London, Ontario
  96. Mississauga, Ontario
  97. Sarnia, Ontario
  98. Toronto, Ontario
  99. Toronto, Ontario
  100. Chicoutimi, Quebec
  101. Chicoutimi, Quebec
  102. Montreal, Quebec
  103. Montreal, Quebec
  104. Montreal, Quebec
  105. Montreal, Quebec
  106. Montreal, Quebec
  107. Montreal, Quebec
  108. Quebec,
  109. Quebec,
  110. 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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 28, 2019)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 6, 2021
Actual Primary Completion Date March 2, 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 information is only displayed when the study is recruiting subjects
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 April 2021

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