Phase 2
N=305
Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
Nonalcoholic Fatty Liver Disease · Nonalcoholic Steatohepatitis
Bottom Line
View on ClinicalTrials.gov: NCT03248882 ↗Enrolled (actual)
305
Serious AEs
2.0%
Results posted
Mar 2020
Primary outcome: Primary: Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16 — -7.2; -17.1; -49.9; -55.9 Percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); PF-05221304 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16 |
-7.2; -17.1; -49.9; -55.9; -64.8 | — |
| SECONDARY Percent Change From Baseline in Alanine Aminotransferase at Week 16 |
-8.5; -12.5; -27.7; -31.3; -46.8 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events |
41; 40; 42; 45; 40; 0 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities |
39; 44; 36; 33; 40 | — |
| SECONDARY Number of Participants With Vital Signs Data Meeting Predefined Criteria |
0; 0; 0; 0; 2; 0 | — |
| SECONDARY Number of Participants With 12-Lead Electrocardiogram (ECG) Data Meeting Predefined Criteria |
0; 0; 0; 0; 0; 0 | — |
Summary
Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03248882). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.