Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)

Pfizer

Status and phase: Completed; Phase 2

Conditions: Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis

Treatments: Drug: PF-05221304; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03248882

2017-001156-55 (EudraCT Number)

C1171002

Details and patient eligibility

About

Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)

Full description

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

Enrollment: 305 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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305 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Double-Blind, PF-05221304-matching Placebo

Treatment:

Drug: Placebo

PF-05221304 - 2 mg

Active Comparator group

Description:

PF-05221304 - 2 mg, once-daily

Treatment:

Drug: PF-05221304

PF-05221304 - 10 mg

Active Comparator group

Description:

PF-05221304 - 10 mg, once-daily

Treatment:

Drug: PF-05221304

PF-05221304 - 25 mg

Active Comparator group

Description:

PF-05221304 - 25 mg, once-daily

Treatment:

Drug: PF-05221304

PF-05221304 - 50 mg

Active Comparator group

Description:

PF-05221304 - 50 mg, once-daily

Treatment:

Drug: PF-05221304