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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 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).
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 moreSide effects data
From 2022 Phase 2 trial • 75 Patients • NCT0439953811%
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