Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)

Pfizer

Status and phase: Completed; Phase 2

Conditions: Nonalcoholic Steatohepatitis With Liver Fibrosis; Nonalcoholic Fatty Liver Disease

Treatments: Drug: PF-05221304; Drug: Placebo; Drug: PF-06865571

Study type: Interventional

Funder types: Industry

Identifiers

NCT04321031

2019-004775-39 (EudraCT Number)

C2541013

Details and patient eligibility

About

The study aims to evaluate two, orally administered, investigational agents - PF-06865571 (DGAT2 inhibitor) and the coadministration of PF-06865571 with PF-05221304 (ACC inhibitor). This study is specifically designed to evaluate the effect of a range of doses of DGAT2i alone, and DGAT2i + ACCi, on resolution of NASH or improvement in liver fibrosis, as assessed histologically (via liver biopsy).

Enrollment: 256 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Biopsy proven NASH with either F2 or F3 fibrosis, per NASH CRN definition
• BMI >/= 22.5kg/m2

Exclusion criteria

• Evidence of other causes of liver disease such as Alcoholic steatohepatitis, (de)compensated cirrhosis, active viral hepatitis
• Any condition possibly affecting drug absorption -Unstable concomitant medical conditions, based on medical history or screening laboratory results including-
• unstable liver function tests, recent cardiovascular event(s) significant malignancies,

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

256 participants in 7 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

participants will receive medication for 48 weeks

Treatment:

Drug: Placebo

PF-06865571 25 milligrams (mg) twice daily (BID)

Experimental group

Description:

participants will receive medication for 48 weeks

Treatment:

Drug: PF-06865571

PF-06865571 75 mg BID

Experimental group

Description:

participants will receive medication for 48 weeks

Treatment:

Drug: PF-06865571

PF-06865571 150 mg BID

Experimental group

Description:

participants will receive medication for 48 weeks

Treatment:

Drug: PF-06865571

PF-06865571 300 mg BID

Experimental group

Description:

participants will receive medication for 48 weeks

Treatment:

Drug: PF-06865571

PF-06865571 (150 mg BID) + PF-05221304 (5 mg BID)

Experimental group

Description:

participants will receive medication for 48 weeks

Treatment:

Drug: PF-06865571

Drug: PF-05221304

PF-06865771 (300 mg BID) + PF-05221304 (10 mg BID)

Experimental group

Description:

participants will receive medication for 48 weeks

Treatment:

Drug: PF-06865571

Drug: PF-05221304