Phase 2
N=53
6-week Safety and PD Study in Adults With NAFLD
Non-alcoholic Fatty Liver Disease
Bottom Line
View on ClinicalTrials.gov: NCT03256526 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Percent Change From Baseline in Whole Liver Fat at Week 6 — -7.97; 2.84; -25.43 Percent Change — p=0.1654
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); PF-06835919 Low Dose (Drug); PF-06835919 High Dose (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Whole Liver Fat at Week 6 |
-7.97; 2.84; -25.43 | 0.1654 |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
5; 4; 5; 0; 1; 1 | — |
| SECONDARY Number of Participants With Post-dose Vital Signs Data Meeting Categorical Criteria |
1; 0; 1; 0; 0; 2 | — |
| SECONDARY Number of Participants With Post-dose ECG Data Meeting Categorical Criteria |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities |
9; 8; 8 | — |
Summary
IN THIS PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, 3 ARM, PARALLEL- GROUP STUDY, SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED ONCE DAILY FOR 6 WEEKS WILL BE ASSESSED IN ADULTS WITH NONALCOHOLIC FATTY LIVER DISEASE
Eligibility Criteria
Inclusion Criteria
- BMI at least 28 kg/m2
- Type 2 diabetes and/or metabolic syndrome
Exclusion Criteria
- Liver disease
- Type 1 diabetes
- Recent heart attack or stroke
- Inability to have an MRI scan
Data sourced from ClinicalTrials.gov (NCT03256526). 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.