| Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD) |
| A Phase 2a, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel Group Study To Evaluate Safety, Tolerability, And Pharmacodynamics Of Pf-05221304 Administered Daily For 16-weeks To Adult Subjects With Nonalcoholic Fatty Liver Disease |
| Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD) |
| A Phase 2a, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel Group Study To Evaluate Safety, Tolerability, And Pharmacodynamics Of PF-05221304 Administered Daily For 16-weeks To Adult Subjects With Nonalcoholic Fatty Liver Disease |
| Interventional |
| Phase 2 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
C1171002 is a randomized, double blind, placebo controlled, 5 arm (placebo, plus 4 active doses of PF 05221304), parallel group study.
Masking: Double (Participant, Investigator)
Masking Description:
Double-Blind
Primary Purpose: Treatment
|
- Nonalcoholic Fatty Liver Disease
- Nonalcoholic Steatohepatitis
|
|
|
- Placebo Comparator: Placebo
Double-Blind, PF-05221304-matching Placebo
Intervention: Drug: Placebo
- Active Comparator: PF-05221304 - 2 mg
PF-05221304 - 2 mg, once-daily
Intervention: Drug: PF-05221304
- Active Comparator: PF-05221304 - 10 mg
PF-05221304 - 10 mg, once-daily
Intervention: Drug: PF-05221304
- Active Comparator: PF-05221304 - 25 mg
PF-05221304 - 25 mg, once-daily
Intervention: Drug: PF-05221304
- Active Comparator: PF-05221304 - 50 mg
PF-05221304 - 50 mg, once-daily
Intervention: Drug: PF-05221304
|
| Not Provided |
| |
| Recruiting |
| 360 |
| March 28, 2019 |
| February 28, 2019 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- Body Mass Index >= 25 kg/m2
- Body Weight > 50 kg
- Liver fat (assessed via MRI-PDFF) >= 8%
- Biopsy-proven NASH - diagnosed in previous 24-months
- Presumed NASH - per Sponsor's definition
- NAFLD with minimal inflammation/fibrosis
- Features of Metabolic Syndrome
Exclusion Criteria:
- Alcohol-induced steatohepatitis or other forms of chronic liver disease
- Positive for Hepatitis B, Hepatitis C, or Human Deficiency Virus
- Severe Renal Impairment
- Contraindications for MRI
|
| Sexes Eligible for Study: |
All |
|
| 18 Years to 70 Years (Adult, Senior) |
| No |
|
| Australia, Canada, Poland, United States |
| |
| |
| NCT03248882 |
C1171002
2017-001156-55 ( EudraCT Number ) |
| Yes |
| Studies a U.S. FDA-regulated Drug Product: |
Yes |
| Studies a U.S. FDA-regulated Device Product: |
No |
|
|
|
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| December 2017 |
