Phase 1 N=48 Randomized Double-blind Basic Science

2-Week Study In People With Nonalcoholic Fatty Liver Disease

Non-alcoholic Steatohepatitis · Non-alcoholic Fatty Liver Disease

Bottom Line

View on ClinicalTrials.gov: NCT03513588 ↗

Enrolled (actual)

Serious AEs

2.1%

Results posted

Mar 2020

Primary outcome: Primary: Relative Change From Baseline in Whole Liver Fat at Day 15 as Assessed by Magnetic Resonance Imaging (MRI) - Proton Density Fat Fraction (PDFF) — -10.94; -32.62; -41.14 percentage of whole liver fat — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Placebo (Drug); PF-06865571 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Mar 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Relative Change From Baseline in Whole Liver Fat at Day 15 as Assessed by Magnetic Resonance Imaging (MRI) - Proton Density Fat Fraction (PDFF)	-10.94; -32.62; -41.14	<0.001 sig
SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	2; 12; 9; 0; 0; 1	—
SECONDARY Number of Participants With Laboratory Test Abnormalities	5; 8; 6	—
SECONDARY Number of Participants With Vital Sign Abnormalities	0; 0; 0; 2; 1; 2	—
SECONDARY Number of Participants With Electrocardiogram (ECG) Abnormalities	0; 0; 0; 0; 0; 0	—
SECONDARY Maximum Plasma Concentration (Cmax) For PF-06865571	345.5; 2001	—
SECONDARY Area Under the Plasma Concentration-Time Profile Over the Dosing Interval (AUCtau) For PF-06865571	1036; 7798	—
SECONDARY Time to Reach Maximum Plasma Concentration (Tmax) For PF-06865571	2.00; 2.00	—
SECONDARY Minimum Plasma Concentration (Cmin) For PF-06865571	6.609; 57.79	—
SECONDARY Apparent Oral Clearance (CL/F) For PF-06865571	48.30; 38.49	—
SECONDARY Peak-to-Trough Ratio (PTR) For PF-06865571	53.17; 34.63	—

Summary

2-week study in people with nonalcoholic fatty liver disease. Study drug at 1 of 2 doses, or placebo, will be given for 14 days. Blood samples, heart monitoring, vital signs, and imaging procedures will be performed.

Eligibility Criteria

Inclusion Criteria

controlled attenuation parameter greater than or equal to 260 dB/m via FibroScan
liver fat greater than or equal to 6% via MRI

Exclusion Criteria

Chronic liver disease
Type 2 diabetes requiring drug treatment
Unable to undergo MRI
History of heart attack or stroke

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03513588). 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.