NCT04399538|CompletedPhase 2ResultsDMCFDA Drug

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

A PHASE 2A, 2-PART, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY PLACEBO-CONTROLLED, PARALLEL-GROUP (SPONSOR OPEN) STUDY TO ASSESS PHARMACODYNAMICS AND SAFETY OF PF-06865571 (DGAT2I) COADMINISTERED WITH PF-05221304 (ACCI) IN ADULT PARTICIPANTS WITH PRESUMED NONALCOHOLIC STEATOHEPATITIS (NASH)

Pfizer ClinicalTrials.gov

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1 other identifier

C3711005

Study Type

interventional

Target

Locations

2 countries

Sites

Timeline

RegisteredMay 2020

StartedAug 2020

CompletionApr 2022

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Aug 2020

Geographic Reach

2 countries

20 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.7 years study duration

First Submitted

Initial submission to the registry

May 20, 2020

Completed

2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2020

Completed

3 months until next milestone

Study Start

First participant enrolled

August 10, 2020

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed

28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2022

Completed

12 months until next milestone

Results Posted

Study results publicly available

April 13, 2023

Completed

Last Updated

April 13, 2023

Status Verified

March 1, 2023

Enrollment Period

1.6 years

First QC Date

May 20, 2020

Results QC Date

March 20, 2023

Last Update Submit

March 20, 2023

Conditions

Nonalcoholic Steatohepatitis Nonalcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

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
MRI-PDFF technique is an established method that enables quantification of fat content in the liver. It measures the fraction of mobile protons in the liver attributable to fat content and provides whole liver coverage so that fat content can be assessed across 8 Couinaud liver segments. Whole liver PDFF = the sum of PDFFs for (Segment I + Segment II + Segment III + Segment IVa + Segment IVb + Segment V + Segment VI + Segment VII + Segment VIII) divided by (number of segments assessed and no missing/mapping at Baseline, and on Week 6). If some segments did not have results reported at Baseline and/or Week 6, liver PDFF was to be calculated using data in segments that had data available at both Baseline visit and Week 6 visit. For this outcome measure (OM), baseline is defined as the assessment undertaken between Visit 3/Week -2 and Visit 4/Day 1.
Baseline, Week 6

Secondary Outcomes (7)

Percent CFB in Fasting Serum Triglycerides at Week 6
Baseline, Week 6
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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).
Number of Participants With TEAEs of Special Interest by Preferred Term (PT)
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).
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
From baseline to end of follow-up or until study discontinuation/withdrawal, whichever was longer (maximum of approximately 19 weeks)
Number of Participants With Abnormalities in Laboratory Parameters of Special Interest Meeting Pre-Defined Criteria
From baseline to end of follow-up or until study discontinuation/withdrawal, whichever was longer (maximum of approximately 19 weeks)
+2 more secondary outcomes