Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis

Pfizer

Status and phase: Completed; Phase 2

Conditions: Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04399538

C3711005

Details and patient eligibility

About

The study will evaluate the effect of coadministration of a range of doses of DGAT2i with 1 dose of ACCi, on hepatic steatosis and the ability of DGAT2i to mitigate ACCi-induced elevations in serum triglycerides. The study has a 2-part design with sequential conduct of Part 1 and Part 2 with each part conducted in distinct/separate cohorts of participants. The overall study design, objectives/endpoints, eligibility criteria for both parts is envisioned to be identical, however, data from Part 1 will be used to determine whether to conduct Part 2.

Enrollment: 75 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI ≥25 and ≤ 40 kg/m2
• concomitant medical conditions associated with NAFLD

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 liver function tests
• Recent cardiovascular event(s),
• Malignancies

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants will receive medication for 6 weeks

Treatment:

Drug: Placebo

DGAT2i (25 mg BID) + ACCi (10 mg BID)

Experimental group

Description:

Participants will receive medication for 6 weeks

Treatment:

Drug: PF-06865571

Drug: PF-05221304

DGAT2i (100 mg BID) + ACCi (10 mg BID)

Experimental group

Description:

Participants will receive medication for 6 weeks

Treatment:

Drug: PF-06865571

Drug: PF-05221304

DGAT2i (300 mg QD) + ACCi (20 mg QD)

Experimental group

Description:

Participants will receive medication for 6 weeks

Treatment:

Drug: PF-06865571

Drug: PF-05221304

DGAT2i (300 mg BID) + ACCi (10 mg BID)

Experimental group

Description:

Participants will receive medication for 6 weeks

Treatment:

Drug: PF-06865571

Drug: PF-05221304