Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
53 participants
INTERVENTIONAL
2017-09-27
2018-04-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Placebo
Placebo
0 mg
PF-06835919 Low Dose
75 mg once daily
PF-06835919 Low Dose
75 mg once daily
PF-06835919 High Dose
300 mg once daily
PF-06835919 High Dose
300 mg once daily
Interventions
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Placebo
0 mg
PF-06835919 Low Dose
75 mg once daily
PF-06835919 High Dose
300 mg once daily
Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes and/or metabolic syndrome
Exclusion Criteria
* Type 1 diabetes
* Recent heart attack or stroke
* Inability to have an MRI scan
18 Years
65 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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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
Avail Clinical Research, LLC
DeLand, Florida, United States
Stand-Up MRI of Miami
Miami, Florida, United States
Avail Clinical Research, LLC
Orange City, Florida, United States
Qps-Mra, Llc
South Miami, Florida, United States
Sterling Research Group, Ltd.
Cincinnati, Ohio, United States
WR-ClinSearch LLC
Chattanooga, Tennessee, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
National Clinical Research, Inc
Richmond, Virginia, United States
Countries
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C1061003
Identifier Type: -
Identifier Source: org_study_id
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