A Study To Assess Pharmacodynamics, Safety And Tolerability Of PF-05221304 And PF-06865571 Co-Administered For 6 Weeks In Adults With Non-Alcoholic Fatty Liver Disease.
NCT ID: NCT03776175
Last Updated: 2020-09-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
99 participants
INTERVENTIONAL
2019-01-04
2019-10-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo (PF 05221304) BID Placebo (PF 06865571) BID
Placebo
Participants enrolled in this Arm will receive 3 tablets for Placebo of PF-05221304 and 3 tablets of Placebo of PF-06865571, to be taken twice daily for 41 days and once on Day 42.
PF-05221304 Monotherapy
15 mg PF-05221304 BID Placebo (PF-06865571) BID
PF-05221304 Monotherapy
Participants enrolled in this Arm will receive 15 mg dose of PF-05221304 (3 tablets of 5 mg each) and 3 tablets of Placebo for PF-06865571, each to be taken twice daily for 41 days and once on Day 42.
Placebo
Participants enrolled in this Arm will receive 3 tablets for Placebo of PF-05221304 and 3 tablets of Placebo of PF-06865571, to be taken twice daily for 41 days and once on Day 42.
PF-06865571 Monotherapy
Placebo (PF-05221304) BID 300 mg PF-06865571 BID
PF-06865571 Monotherapy
Participants enrolled in this Arm will receive 300 mg dose of PF-06865571 (3 tablets of 100 mg each) and 3 tablets of Placebo for PF-05221304, all to be taken twice daily for 41 days and once on Day 42.
Placebo
Participants enrolled in this Arm will receive 3 tablets for Placebo of PF-05221304 and 3 tablets of Placebo of PF-06865571, to be taken twice daily for 41 days and once on Day 42.
PF-05221304 and PF-06865571 Combination
15 mg PF-05221304 BID 300 mg PF-06865571 BID
PF-05221304 Monotherapy
Participants enrolled in this Arm will receive 15 mg dose of PF-05221304 (3 tablets of 5 mg each) and 3 tablets of Placebo for PF-06865571, each to be taken twice daily for 41 days and once on Day 42.
PF-06865571 Monotherapy
Participants enrolled in this Arm will receive 300 mg dose of PF-06865571 (3 tablets of 100 mg each) and 3 tablets of Placebo for PF-05221304, all to be taken twice daily for 41 days and once on Day 42.
PF-05221304 and PF-06865571 Combination
Participants enrolled in this Arm will receive 15 mg dose of PF-05221304 (3 tablets of 5 mg each) and 3 tablets of PF-06865571 (3 tablets of 100 mg each), each to be taken twice daily for 41 days and once on Day 42.
Interventions
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PF-05221304 Monotherapy
Participants enrolled in this Arm will receive 15 mg dose of PF-05221304 (3 tablets of 5 mg each) and 3 tablets of Placebo for PF-06865571, each to be taken twice daily for 41 days and once on Day 42.
PF-06865571 Monotherapy
Participants enrolled in this Arm will receive 300 mg dose of PF-06865571 (3 tablets of 100 mg each) and 3 tablets of Placebo for PF-05221304, all to be taken twice daily for 41 days and once on Day 42.
Placebo
Participants enrolled in this Arm will receive 3 tablets for Placebo of PF-05221304 and 3 tablets of Placebo of PF-06865571, to be taken twice daily for 41 days and once on Day 42.
PF-05221304 and PF-06865571 Combination
Participants enrolled in this Arm will receive 15 mg dose of PF-05221304 (3 tablets of 5 mg each) and 3 tablets of PF-06865571 (3 tablets of 100 mg each), each to be taken twice daily for 41 days and once on Day 42.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Total body weight of \>50 kg (110 lbs) and a BMI greater than or equal to 25 kg/m2
* Medical diagnosis of Type 2 Diabetes Mellitus (T2DM) being treated with no more than 1 acceptable oral antidiabetic drug OR Subjects without a diagnosis of T2DM that meet 2 or more of the following 5 criteria commonly associated with metabolic syndrome
* Fasting Plasma Glucose (FPG) greater than or equal to 100 mg/dL;
* Documentation of at least stage 1 hypertension or medical history of hypertension;
* Fasting serum HDL C \<40 mg/dL for males and \<50 mg/dL for females, or on pharmacological agents with explicit purpose to increase HDL-C;
* Fasting serum triglyceride (TG) greater than or equal to 150 mg/dL or on pharmacological agents with explicit purpose to decrease TG;
* Waist circumference greater than or equal to 40 inches (102 cm) for males and 35 inches (89 cm) for females.
* Liver fat greater than or equal to 8% measured by MRI PDFF
Exclusion Criteria
* Subjects with any of the following clinical laboratory abnormalities:
* Fasting TG \>400 mg/dL;
* AST, ALT, or GGT \>2.0x ULN;
* Hemoglobin A1c (HbA1c) \>7.0%;
* Fasting plasma glucose \>270 mg/dL;
* Total bilirubin \>1.5x ULN;
* Albumin \< lower limit of normal (LLN);
* Platelet count \<0.95x LLN;
* International normalized ratio (INR) greater than or equal to 1.3.
* A positive urine test for illicit drugs.
* History of regular alcohol consumption.
* Seated systolic BP\>=160 mmHg and/or diastolic BP\>=100 mmHg.
* Supine 12 lead ECG demonstrating a corrected QT (QTcF) interval \>450 msec or a QRS interval \>120 msec.
* Subjects with an estimated GFR \<60 mL/min/1.73m2.
* Evidence or diagnosis of other forms of chronic liver diseases.
* Subjects with any of the following medical conditions:
* Any condition possibly affecting drug absorption (eg prior bariatric surgery, gastrectomy, ileal resection);
* Diagnosis of type 1 diabetes mellitus;
* History of congestive heart failure, unstable angina, myocardial infarction, stroke, or transient ischemic attack;
* Any malignancy not considered cured (except basal cell carcinoma and squamous cell carcinoma of the skin);
* Active placement of medical devices in/on thoracic or abdominal cavities such as pacemakers, defibrillators;
* Subjects with any anatomical or pathological abnormality that would either preclude or tend to confound the analysis of study data.
* Blood donation of approximately 1 pint or more within 60 days prior to dosing.
* Subjects taking prohibited concomitant medication(s) or those unwilling/unable to switch to permitted concomitant medication(s)
* Weight loss of greater than or equal to 5% within 1 month prior to Screening.
* Unwilling or unable to comply with the Lifestyle Requirements criteria of the protocol.
* Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential; fertile male subjects who are unwilling or unable to use highly effective method(s) of contraception.
* Investigator site staff members or Pfizer employees, including their family members, directly involved in the conduct of the study.
* Subjects with known prior treatment with or participation in a clinical trial involving any of the IPs
18 Years
70 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Franco Felizarta, Md
Bakersfield, California, United States
Westside Medical Associates of Los Angeles
Beverly Hills, California, United States
ProSciento, Inc.
Chula Vista, California, United States
National Research Institute - Wilshire
Los Angeles, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
Floridian Clinical Research, LLC
Hialeah, Florida, United States
Research Centers of America, LLC
Hollywood, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Pharmax Research Clinic
Miami, Florida, United States
Omega Research Maitland
Orlando, Florida, United States
Accel Research Sites
Orlando, Florida, United States
Advanced Gastroenterology Associates, LLC
Palm Harbor, Florida, United States
QPS-MRA, LLC-Main Office
South Miami, Florida, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Midwest Institute for Clinical Research
Indianapolis, Indiana, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
L-MARC Research Center
Louisville, Kentucky, United States
Clarity Clinical Research
East Syracuse, New York, United States
High Point Clinical Trials Center
High Point, North Carolina, United States
M3 Wake Research, Inc
Raleigh, North Carolina, United States
Wake Gastroenterology
Raleigh, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Sterling Research Group - Mt. Auburn
Cincinnati, Ohio, United States
New Horizons Clinical Research
Cincinnati, Ohio, United States
WR-Clinsearch, LLC
Chattanooga, Tennessee, United States
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States
University of Tennessee Medical Center - Radiology
Knoxville, Tennessee, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
National Clinical Research-Richmond, Inc.
Richmond, Virginia, United States
Countries
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References
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Calle RA, Amin NB, Carvajal-Gonzalez S, Ross TT, Bergman A, Aggarwal S, Crowley C, Rinaldi A, Mancuso J, Aggarwal N, Somayaji V, Inglot M, Tuthill TA, Kou K, Boucher M, Tesz G, Dullea R, Bence KK, Kim AM, Pfefferkorn JA, Esler WP. ACC inhibitor alone or co-administered with a DGAT2 inhibitor in patients with non-alcoholic fatty liver disease: two parallel, placebo-controlled, randomized phase 2a trials. Nat Med. 2021 Oct;27(10):1836-1848. doi: 10.1038/s41591-021-01489-1. Epub 2021 Oct 11.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C3711001
Identifier Type: -
Identifier Source: org_study_id
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