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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

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ClinicalTrials.gov Identifier: NCT03969719
Recruitment Status : Recruiting
First Posted : May 31, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Non-alcoholic Steatohepatitis Drug: Placebo Drug: PF-06835919 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : July 18, 2019
Estimated Primary Completion Date : February 10, 2021
Estimated Study Completion Date : February 10, 2021


Arm Intervention/treatment
Placebo Comparator: Placebo
Palacebo
Drug: Placebo
Placebo

Experimental: Low Dose
150 mg
Drug: PF-06835919
150 mg once daily

Experimental: High Dose
300 mg
Drug: PF-06835919
300 mg once daily




Primary Outcome Measures :
  1. Percent change from baseline in whole liver fat at Week 16 [ Time Frame: Baseline and Week 16 ]
  2. Change from baseline in glycosylated hemoglobin (HbA1c) at Week 16 [ Time Frame: Baseline and Week 16 ]

Secondary Outcome Measures :
  1. Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) [ Time Frame: Baseline through 28 days after last dose ]
  2. Number of Participants With Treatment Emergent Treatment-Related Hypoglycemia Adverse Events (HAEs) [ Time Frame: Baseline through 28 days after last dose ]
  3. Number of Participants With Clinical Laboratory Abnormalities [ Time Frame: Baseline through follow-up visit ]
  4. Change from Baseline in Blood Pressure [ Time Frame: Baseline through follow-up visit ]
  5. Number of Participants With Abnormal Electrocardiogram (ECG) [ Time Frame: Baseline through follow-up visit ]
  6. Percent change from baseline in high-sensitivity C-Reactive Protein (hs-CRP) [ Time Frame: Baseline through Week 16 ]
  7. Change from baseline in fasting insulin [ Time Frame: Baseline through Week 16 ]
  8. Change from baseline in fasting glucose [ Time Frame: Baseline through Week 16 ]
  9. Change from baseline in HOMA-IR [ Time Frame: Baseline through Week 16 ]
  10. Percent change from baseline in alanine aminotransferse (ALT) [ Time Frame: Baseline through Week 16 ]
  11. Change from baseline in glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline through Week 14 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03969719


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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United States, Arizona
Horizon Clinical Research Associates Not yet recruiting
Gilbert, Arizona, United States, 85295
Scottsdale Medical Imaging Research, LLC Not yet recruiting
Gilbert, Arizona, United States, 85297
United States, California
Anaheim Clinical Trials Not yet recruiting
Anaheim, California, United States, 92801
Shin Medical Imaging Not yet recruiting
Fullerton, California, United States, 92835
eStudySite Not yet recruiting
La Mesa, California, United States, 91942
Clinical Trials Research Not yet recruiting
Lincoln, California, United States, 95648
National Research Institute Not yet recruiting
Los Angeles, California, United States, 90057
Huntington Medical Research Institute Not yet recruiting
Pasadena, California, United States, 91105
Inland Empire Clinical Trials, LLC Not yet recruiting
Rialto, California, United States, 92377
Sharp & Children's MRI Center, LLC Not yet recruiting
San Diego, California, United States, 92123
Liberty Pacific Advanced Imaging Not yet recruiting
Tarzana, California, United States, 91356
United States, Florida
ENCORE Borland-Groover Clinical Research Not yet recruiting
Jacksonville, Florida, United States, 32256
Clinical Research of Miami Not yet recruiting
Miami, Florida, United States, 33126
Suncoast Research Group, LLC Not yet recruiting
Miami, Florida, United States, 33135
Stand Up MRI of Miami Not yet recruiting
Miami, Florida, United States, 33145
Qps-Mra, Llc Recruiting
South Miami, Florida, United States, 33143
United States, Hawaii
East-West Medical Research Institute Recruiting
Honolulu, Hawaii, United States, 96814
United States, Kansas
Alliance Multispecialty Research, LLC Not yet recruiting
Wichita, Kansas, United States, 67207
United States, Michigan
AA MRC Not yet recruiting
Flint, Michigan, United States, 48504
United States, New York
BioTel Research (Cardiocore & VirtualScopics) Not yet recruiting
Rochester, New York, United States, 14623
United States, Texas
Clinical Trials of Texas Not yet recruiting
San Antonio, Texas, United States, 78229
South Texas Radiology Imaging Centers Not yet recruiting
San Antonio, Texas, United States, 78233
STRIC Northeast Imaging Center (MRI) Not yet recruiting
San Antonio, Texas, United States, 78233
Northeast Clinical Research of San Antonio, LLC (NECRSA, LLC) Not yet recruiting
Schertz, Texas, United States, 78154
Canada, Ontario
Aggarwal and Associates Limited Recruiting
Brampton, Ontario, Canada, L6T 0G1
Oxford Medical Imaging - (MRI Facility) Recruiting
Mississauga, Ontario, Canada, L5R 3K7
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03969719     History of Changes
Other Study ID Numbers: C1061011
DOSE RESPONSE IN PATIENTS ( Other Identifier: Alias Study Number )
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
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/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Non-alcoholic steatohepatitis; Type 2 Diabetes Mellitus
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Digestive System Diseases