2-Week Study In People With Nonalcoholic Fatty Liver Disease

NCT ID: NCT03513588

Last Updated: 2020-03-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-21

Study Completion Date

2019-04-04

Brief Summary

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2-week study in people with nonalcoholic fatty liver disease. Study drug at 1 of 2 doses, or placebo, will be given for 14 days. Blood samples, heart monitoring, vital signs, and imaging procedures will be performed.

Detailed Description

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Conditions

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Non-alcoholic Steatohepatitis Non-alcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

tablet, 0 mg, 14 days, every 12 hours

PF-06865571 100 mg

Group Type EXPERIMENTAL

PF-06865571

Intervention Type DRUG

tablet, 50 mg, 14 days, every 12 hours

PF-06865571 600 mg

Group Type EXPERIMENTAL

PF-06865571

Intervention Type DRUG

tablet, 300 mg, 14 days, every 12 hours

Interventions

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Placebo

tablet, 0 mg, 14 days, every 12 hours

Intervention Type DRUG

PF-06865571

tablet, 50 mg, 14 days, every 12 hours

Intervention Type DRUG

PF-06865571

tablet, 300 mg, 14 days, every 12 hours

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* controlled attenuation parameter greater than or equal to 260 dB/m via FibroScan
* liver fat greater than or equal to 6% via MRI

Exclusion Criteria

* Chronic liver disease
* Type 2 diabetes requiring drug treatment
* Unable to undergo MRI
* History of heart attack or stroke
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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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Anaheim Clinical Trials, LLC

Anaheim, California, United States

Site Status

New Haven Clinical Research Unit

New Haven, Connecticut, United States

Site Status

Qps-Mra, Llc

South Miami, Florida, United States

Site Status

PPD Development, LP

Las Vegas, Nevada, United States

Site Status

High Point Clinical Trials Center

High Point, North Carolina, United States

Site Status

Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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Amin NB, Saxena AR, Somayaji V, Dullea R. Inhibition of Diacylglycerol Acyltransferase 2 Versus Diacylglycerol Acyltransferase 1: Potential Therapeutic Implications of Pharmacology. Clin Ther. 2023 Jan;45(1):55-70. doi: 10.1016/j.clinthera.2022.12.008. Epub 2023 Jan 21.

Reference Type DERIVED
PMID: 36690550 (View on PubMed)

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=C2541005

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

Other Identifiers

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C2541005

Identifier Type: -

Identifier Source: org_study_id

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