A Double-blind Study to Assess 2 Doses of an Investigational Product for 16 Weeks in Participants With Non-alcoholic Fatty Liver Disease and Type 2 Diabetes Mellitus

Pfizer

Status and phase: Completed; Phase 2

Conditions: Non-alcoholic Steatohepatitis

Treatments: Drug: PF-06835919; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03969719

DOSE RESPONSE IN PATIENTS (Other Identifier)

C1061011

Details and patient eligibility

About

This is a double-blind, placebo-controlled study in adults with non-alcoholic steatohepatitis and Type 2 Diabetes Mellitis on stable dose of metformin monotherapy. Participants will be treated for 16 weeks with placebo or 1 of 2 doses of investigational product to determine the effect on liver fat, HbA1c, safety, tolerability and pharmacodynamics.

Enrollment: 164 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males, or females of nonchildbearing potential
• 18 to 70 years of age
• Type 2 Diabetes Mellitus
• Liver fat >/=8% by MRI-PDFF
• On stable dose of metformin monotherapy for at least 2 months (at a dose of at least 500 mg daily)

Exclusion criteria

• History of other liver disease
• Unable to have an MRI performed
• Significant weight loss in the previous month and/or participant in current weight loss program
• History of diabetic complications with end-organ damage

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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164 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Palacebo

Treatment:

Drug: Placebo

Low Dose

Experimental group

Description:

150 mg

Treatment:

Drug: PF-06835919

Drug: PF-06835919

High Dose

Experimental group

Description:

300 mg

Treatment:

Drug: PF-06835919

Drug: PF-06835919