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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.

Last updated on June 7, 2019

FOR MORE INFORMATION
Study Location
Research Centers of America, LLC
Hollywood, Florida, 33024 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Alcoholic Fatty Liver Disease (NAFLD)
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.
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- Male subjects or female subjects of non childbearing potential

- 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 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Subjects with acute or chronic medical or psychiatric condition.

- 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

- Platelet count

- 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

- 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

NCT03776175
Pfizer
Recruiting
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.

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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