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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.

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ClinicalTrials.gov Identifier: NCT03776175
Recruitment Status : Completed
First Posted : December 14, 2018
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This study is to assess the effect of PF 05221304 alone, PF 06865571 alone, the co administration of PF 05221304 and PF 06865571, or placebo on whole liver fat in subjects with NAFLD. In addition, this study will evaluate the safety and tolerability of co administration of PF 05221304 and PF 06865571 along with the effects on selected pharmacodynamics (PD)/exploratory parameters, compared to administration of PF 05221304 alone, PF 06865571 alone, and placebo in adults with NAFLD.

Condition or disease Intervention/treatment Phase
Non-Alcoholic Fatty Liver Disease (NAFLD) Drug: PF-05221304 Monotherapy Drug: PF-06865571 Monotherapy Drug: Placebo Drug: PF-05221304 and PF-06865571 Combination Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A PHASE 2A, RANDOMIZED, DOUBLE BLIND (SPONSOR-OPEN), PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE PHARMACODYNAMICS, SAFETY AND TOLERABILITY OF PF-05221304 AND PF-06865571 CO-ADMINISTERED FOR 6 WEEKS IN ADULTS WITH NON-ALCOHOLIC FATTY LIVER DISEASE (NAFLD)
Actual Study Start Date : January 4, 2019
Actual Primary Completion Date : September 9, 2019
Actual Study Completion Date : October 11, 2019


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo (PF 05221304) BID Placebo (PF 06865571) BID
Drug: 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.
Other Name: Arm A

Experimental: PF-05221304 Monotherapy
15 mg PF-05221304 BID Placebo (PF-06865571) BID
Drug: 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.
Other Name: Arm B

Drug: 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.
Other Name: Arm A

Experimental: PF-06865571 Monotherapy
Placebo (PF-05221304) BID 300 mg PF-06865571 BID
Drug: 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.
Other Name: Arm C

Drug: 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.
Other Name: Arm A

Experimental: PF-05221304 and PF-06865571 Combination
15 mg PF-05221304 BID 300 mg PF-06865571 BID
Drug: 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.
Other Name: Arm B

Drug: 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.
Other Name: Arm C

Drug: 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 Name: Arm D




Primary Outcome Measures :
  1. Relative change in whole liver fat as assessed by magnetic resonance imaging proton density fat fraction (MRI‑PDFF). [ Time Frame: Baseline up to Day 42 ]
    Mean relative changes between placebo and each active drug arm (PF‑05221304 monotherapy, PF‑06865571 monotherapy and PF‑05221304 plus PF‑06865571 combination) will be evaluated.


Secondary Outcome Measures :
  1. Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 14 Days after last dose ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

  2. Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings [ Time Frame: Baseline up to 14 Days after last dose ]
    Clinically significant ECG findings included: QT interval, heart rate, QTcF interval, PR interval, and QRS interval.

  3. Percentage of Participants With Clinically Significant Change From Baseline in Vital Signs [ Time Frame: Baseline up to 14 Days after last dose ]
    Changes from baseline in systolic blood pressure, diastolic blood pressure and pulse rate.

  4. Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities [ Time Frame: Baseline up to 14 Days after last dose ]
    Laboratory parameters included: hematology, chemistry, and urinalysis Clinical significance of laboratory parameters was determined at the investigator's discretion.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • 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 <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 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 < 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

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): NCT03776175


Locations
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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: NCT03776175    
Other Study ID Numbers: C3711001
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: March 2020
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
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases