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.

PHASE2CompletedINTERVENTIONAL
Enrollment

99

Participants

Timeline

Start Date

January 4, 2019

Primary Completion Date

September 9, 2019

Study Completion Date

October 11, 2019

Conditions
Non-Alcoholic Fatty Liver Disease (NAFLD)
Interventions
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.

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.

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.

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.

Trial Locations (29)

13057

Clarity Clinical Research, East Syracuse

23294

National Clinical Research-Richmond, Inc., Richmond

27265

High Point Clinical Trials Center, High Point

27612

M3 Wake Research, Inc, Raleigh

Wake Gastroenterology, Raleigh

28401

PMG Research of Wilmington, LLC, Wilmington

32216

Jacksonville Center for Clinical Research, Jacksonville

32810

Omega Research Maitland, Orlando

32819

Accel Research Sites, Orlando

33016

Floridian Clinical Research, LLC, Hialeah

33024

Research Centers of America, LLC, Hollywood

33126

Pharmax Research Clinic, Miami

33143

QPS-MRA, LLC-Main Office, South Miami

34684

Advanced Gastroenterology Associates, LLC, Palm Harbor

37421

WR-Clinsearch, LLC, Chattanooga

37920

New Orleans Center for Clinical Research, Knoxville

University of Tennessee Medical Center - Radiology, Knoxville

40213

L-MARC Research Center, Louisville

45219

Sterling Research Group - Mt. Auburn, Cincinnati

45242

New Horizons Clinical Research, Cincinnati

46260

Midwest Institute for Clinical Research, Indianapolis

67207

Heartland Research Associates, LLC, Wichita

78229

Clinical Trials of Texas, Inc., San Antonio

90057

National Research Institute - Wilshire, Los Angeles

90211

Westside Medical Associates of Los Angeles, Beverly Hills

91763

Catalina Research Institute, LLC, Montclair

91911

ProSciento, Inc., Chula Vista

93301

Franco Felizarta, Md, Bakersfield

96814

East-West Medical Research Institute, Honolulu

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT03776175 - 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. | Biotech Hunter | Biotech Hunter