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ACC Inhibitor

PF-06865571 for Non-alcoholic Fatty Liver Disease

Phase 2

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to at least 28 days after the last administration of the study intervention or until study completion or withdrawal, whichever was longer (maximum of approximately 24 weeks).

Awards & highlights

Study Summary

This trial will study whether a new drug can help reduce fat in the liver and improve triglyceride levels when taken with another drug. The trial has two parts, and data from the first part will be used to decide whether to do the second part.

Eligible Conditions

Non-alcoholic Fatty Liver Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to at least 28 days after the last administration of the study intervention or until study completion or withdrawal, whichever was longer (maximum of approximately 24 weeks).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to at least 28 days after the last administration of the study intervention or until study completion or withdrawal, whichever was longer (maximum of approximately 24 weeks).

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to at least 28 days after the last administration of the study intervention or until study completion or withdrawal, whichever was longer (maximum of approximately 24 weeks). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent Change From Baseline (CFB) in Percent (%) Liver Fat as Assessed Via Magnetic Resonance Imaging Using Proton Density Fat Fraction Acquisition (MRI-PDFF) at Week 6

Secondary outcome measures

Number of Participants With Abnormalities in Laboratory Parameters of Special Interest Meeting Pre-Defined Criteria

Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality

Number of Participants With Post-Baseline Electrocardiogram (ECG) Data Meeting Pre-Defined Criteria

+4 more

Side effects data

From 2022 Phase 2 trial • 75 Patients • NCT04399538

11%

Diarrhoea

Thrombocytopenia

Cytokeratin 18 increased

Hypertriglyceridaemia

Alanine aminotransferase increased

Vomiting

Type 2 diabetes mellitus

100%

80%

60%

40%

20%

Study treatment Arm

PF-06865571 300 mg QD + PF-05221304 20 mg QD

Placebo

PF-06865571 25 mg BID + PF-05221304 10 mg BID

PF-06865571 100 mg BID + PF-05221304 10 mg BID

PF-06865571 300 mg BID + PF-05221304 10 mg BID

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: DGAT2i (300 mg QD) + ACCi (20 mg QD)Experimental Treatment2 Interventions