2-Week Study In People With Nonalcoholic Fatty Liver Disease

Pfizer

Status and phase: Completed; Phase 1

Conditions: Non-alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis

Treatments: Drug: Placebo; Drug: PF-06865571

Study type: Interventional

Funder types: Industry

Identifiers

NCT03513588

C2541005

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

PF-06865571 100 mg

Experimental group

Treatment:

Drug: PF-06865571

Drug: PF-06865571

PF-06865571 600 mg

Experimental group

Treatment:

Drug: PF-06865571

Drug: PF-06865571