Clinical trial NCT04399538: Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nonalcoholic Steatohepatitis
Nonalcoholic Fatty Liver Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-05-22
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Dose-ranging of combination doses
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Percent CFB in Fasting Serum Triglycerides at Week 6
timeFrame: Baseline, Week 6
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: 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).
measure: Number of Participants With TEAEs of Special Interest by Preferred Term (PT)
timeFrame: 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).
measure: Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
timeFrame: From baseline to end of follow-up or until study discontinuation/withdrawal, whichever was longer (maximum of approximately 19 weeks)
measure: Number of Participants With Abnormalities in Laboratory Parameters of Special Interest Meeting Pre-Defined Criteria
timeFrame: From baseline to end of follow-up or until study discontinuation/withdrawal, whichever was longer (maximum of approximately 19 weeks)
measure: Number of Participants With Post-Baseline Vital Signs Data Meeting Pre-Defined Criteria
timeFrame: Baseline, Week 6, the first follow-up visit (Week 8), and the date of discontinuation/withdrawal from study (maximum of approximately 12 weeks after Day 1) if applicable
measure: Number of Participants With Post-Baseline Electrocardiogram (ECG) Data Meeting Pre-Defined Criteria
timeFrame: Baseline, Week 6, the first follow-up visit (Week 8), and the date of discontinuation/withdrawal from study (maximum of approximately 12 weeks after Day 1) if applicable
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Clinical Trials Research
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC
state: California
city: Boca Raton
country: United States
facility: Excel Medical Clinical Trials
state: Florida
city: Miami Lakes
country: United States
facility: Floridian Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: Optimus U Corporation
state: Florida
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Sterling Research Group, Ltd.
state: Ohio
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Richmond
country: United States
facility: National Clinical Research, Inc.
state: Virginia
city: Halifax
country: Canada
facility: Nova Scotia Health Authority QE II Health Sciences Centre
state: Nova Scotia
city: Halifax
country: Canada
facility: Nova Scotia Health Authority QE II Health Sciences Centre
state: Nova Scotia
city: Halifax
country: Canada
facility: Nova Scotia Health Authority - Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Brampton
country: Canada
facility: Aggarwal and Associates Limited
state: Ontario
city: London
country: Canada
facility: Milestone Research Inc.
state: Ontario
city: Chicoutimi
country: Canada
facility: Resonance Magnetique du Saguenay-Lac-Saint-Jean
state: Quebec
city: Chicoutimi
country: Canada
facility: Ecogene-21
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Saint-Louis
city: Quebec
country: Canada
facility: Alpha Recherche Clinique
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: