6-week Safety and PD Study in Adults With NAFLD

NCT ID: NCT03256526

Last Updated: 2019-04-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-27

Study Completion Date

2018-04-27

Brief Summary

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IN THIS PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, 3 ARM, PARALLEL- GROUP STUDY, SAFETY, TOLERABILITY, AND PHARMACODYNAMICS OF PF-06835919 ADMINISTERED ONCE DAILY FOR 6 WEEKS WILL BE ASSESSED IN ADULTS WITH NONALCOHOLIC FATTY LIVER DISEASE

Detailed Description

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Conditions

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Non-alcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0 mg

PF-06835919 Low Dose

75 mg once daily

Group Type EXPERIMENTAL

PF-06835919 Low Dose

Intervention Type DRUG

75 mg once daily

PF-06835919 High Dose

300 mg once daily

Group Type EXPERIMENTAL

PF-06835919 High Dose

Intervention Type DRUG

300 mg once daily

Interventions

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Placebo

0 mg

Intervention Type DRUG

PF-06835919 Low Dose

75 mg once daily

Intervention Type DRUG

PF-06835919 High Dose

300 mg once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* BMI at least 28 kg/m2
* Type 2 diabetes and/or metabolic syndrome

Exclusion Criteria

* Liver disease
* Type 1 diabetes
* Recent heart attack or stroke
* Inability to have an MRI scan
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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National Research Institute

Los Angeles, California, United States

Site Status

Avail Clinical Research, LLC

DeLand, Florida, United States

Site Status

Stand-Up MRI of Miami

Miami, Florida, United States

Site Status

Avail Clinical Research, LLC

Orange City, Florida, United States

Site Status

Qps-Mra, Llc

South Miami, Florida, United States

Site Status

Sterling Research Group, Ltd.

Cincinnati, Ohio, United States

Site Status

WR-ClinSearch LLC

Chattanooga, Tennessee, 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

Countries

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United States

References

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Kazierad DJ, Chidsey K, Somayaji VR, Bergman AJ, Birnbaum MJ, Calle RA. Inhibition of ketohexokinase in adults with NAFLD reduces liver fat and inflammatory markers: A randomized phase 2 trial. Med. 2021 Jul 9;2(7):800-813.e3. doi: 10.1016/j.medj.2021.04.007. Epub 2021 Apr 27.

Reference Type DERIVED
PMID: 35590219 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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C1061003

Identifier Type: -

Identifier Source: org_study_id

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