6-week Safety and PD Study in Adults With NAFLD

Pfizer

Status and phase: Completed; Phase 2

Conditions: Non-alcoholic Fatty Liver Disease

Treatments: Drug: PF-06835919 Low Dose; Drug: PF-06835919 High Dose; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03256526

C1061003

Details and patient eligibility

About

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

Enrollment: 53 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

PF-06835919 Low Dose

Experimental group

Description:

75 mg once daily

Treatment:

Drug: PF-06835919 Low Dose

PF-06835919 High Dose

Experimental group

Description:

300 mg once daily

Treatment:

Drug: PF-06835919 High Dose