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ACC Inhibitor

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

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).

Summary

This trial tests two medications on patients with fatty liver disease. It aims to see if one medication can reduce liver fat and manage the increase in blood fats caused by the other. These medications have shown promise in early studies.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease

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).
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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
6%
Thrombocytopenia
6%
Cytokeratin 18 increased
6%
Hypertriglyceridaemia
6%
Alanine aminotransferase increased
6%
Vomiting
6%
Type 2 diabetes mellitus
100%
80%
60%
40%
20%
0%
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
Participants will receive medication for 6 weeks
Group II: DGAT2i (300 mg BID) + ACCi (10 mg BID)Experimental Treatment2 Interventions
Participants will receive medication for 6 weeks
Group III: DGAT2i (25 mg BID) + ACCi (10 mg BID)Experimental Treatment2 Interventions
Participants will receive medication for 6 weeks
Group IV: DGAT2i (100 mg BID) + ACCi (10 mg BID)Experimental Treatment2 Interventions
Participants will receive medication for 6 weeks
Group V: PlaceboPlacebo Group1 Intervention
Participants will receive medication for 6 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-05221304
2016
Completed Phase 2
~780
PF-06865571
2018
Completed Phase 2
~480

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,675 Previous Clinical Trials
28,717,107 Total Patients Enrolled
17 Trials studying Non-alcoholic Fatty Liver Disease
3,247 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,556 Previous Clinical Trials
25,757,963 Total Patients Enrolled
9 Trials studying Non-alcoholic Fatty Liver Disease
966 Patients Enrolled for Non-alcoholic Fatty Liver Disease
~14 spots leftby Dec 2025