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

NCT ID: NCT04399538

Last Updated: 2023-04-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-10

Study Completion Date

2022-04-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Nonalcoholic Steatohepatitis Nonalcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Dose-ranging of combination doses
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double-blind, Double-dummy, Placebo controlled

Study Groups

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Placebo

Participants will receive medication for 6 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablet

DGAT2i (25 mg BID) + ACCi (10 mg BID)

Participants will receive medication for 6 weeks

Group Type EXPERIMENTAL

PF-06865571

Intervention Type DRUG

Tablet

PF-05221304

Intervention Type DRUG

Tablet

DGAT2i (100 mg BID) + ACCi (10 mg BID)

Participants will receive medication for 6 weeks

Group Type EXPERIMENTAL

PF-06865571

Intervention Type DRUG

Tablet

PF-05221304

Intervention Type DRUG

Tablet

DGAT2i (300 mg QD) + ACCi (20 mg QD)

Participants will receive medication for 6 weeks

Group Type EXPERIMENTAL

PF-06865571

Intervention Type DRUG

Tablet

PF-05221304

Intervention Type DRUG

Tablet

DGAT2i (300 mg BID) + ACCi (10 mg BID)

Participants will receive medication for 6 weeks

Group Type EXPERIMENTAL

PF-06865571

Intervention Type DRUG

Tablet

PF-05221304

Intervention Type DRUG

Tablet

Interventions

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PF-06865571

Tablet

Intervention Type DRUG

PF-05221304

Tablet

Intervention Type DRUG

Placebo

Tablet

Intervention Type DRUG

Other Intervention Names

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DGAT2i ACCi

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Clinical Trials Research

Lincoln, California, United States

Site Status

Catalina Research Institute, LLC

Montclair, California, United States

Site Status

Excel Medical Clinical Trials

Boca Raton, Florida, United States

Site Status

Optimus U Corporation

Miami, Florida, United States

Site Status

Floridian Clinical Research, LLC

Miami Lakes, Florida, United States

Site Status

East-West Medical Research Institute

Honolulu, Hawaii, United States

Site Status

L-MARC Research Center

Louisville, Kentucky, United States

Site Status

The Christ Hospital

Cincinnati, Ohio, United States

Site Status

Sterling Research Group, Ltd.

Cincinnati, Ohio, United States

Site Status

Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

Site Status

National Clinical Research, Inc.

Richmond, Virginia, United States

Site Status

Nova Scotia Health Authority QE II Health Sciences Centre

Halifax, Nova Scotia, Canada

Site Status

Nova Scotia Health Authority QE II Health Sciences Centre

Halifax, Nova Scotia, Canada

Site Status

Nova Scotia Health Authority - Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Site Status

Aggarwal and Associates Limited

Brampton, Ontario, Canada

Site Status

Milestone Research Inc.

London, Ontario, Canada

Site Status

Resonance Magnetique du Saguenay-Lac-Saint-Jean

Chicoutimi, Quebec, Canada

Site Status

Ecogene-21

Chicoutimi, Quebec, Canada

Site Status

Alpha Recherche Clinique

Québec, Quebec, Canada

Site Status

Centre de Recherche Saint-Louis

Québec, , Canada

Site Status

Countries

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United States Canada

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C3711005

To obtain contact information for a study center near you, click here.

Other Identifiers

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C3711005

Identifier Type: -

Identifier Source: org_study_id

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