Multiple Dose Study Of PF-05231023 In Adult Subjects Who Have Poor Lipid Control With And Without Type 2 Diabetes Mellitus
NCT ID: NCT01673178
Last Updated: 2015-02-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
107 participants
INTERVENTIONAL
2012-10-31
2013-09-30
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
TREATMENT
QUADRUPLE
Study Groups
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Placebo Arm
Placebo
0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), once a week for 4 weeks
25 mg
25 mg PF-05231023
25 mg IV once a week for 4 weeks
50 mg
50 mg PF-05231023
50 mg IV once a week for 4 weeks
100 mg
100 mg PF-05231023
100 mg IV once a week for 4 weeks
150 mg
150 mg PF-05231023
150 mg IV once a week for 4 weeks
Interventions
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Placebo
0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), once a week for 4 weeks
25 mg PF-05231023
25 mg IV once a week for 4 weeks
50 mg PF-05231023
50 mg IV once a week for 4 weeks
100 mg PF-05231023
100 mg IV once a week for 4 weeks
150 mg PF-05231023
150 mg IV once a week for 4 weeks
Eligibility Criteria
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Inclusion Criteria
* Subjects with poor lipid control as confirmed by laboratory tests.
* BMI of 30 to 40 Kg/m2 and a total body weight of \>50 kg (110 lbs).
Exclusion Criteria
* Levels of blood enzymes indicating pancreatitis or elevated liver function enzymes outside of the laboratory's reference range as confirmed by laboratory tests.
* Subjects with Type 1 Diabetes Mellitus.
30 Years
70 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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Anaheim Clinical Trials, LLC
Anaheim, California, United States
Profil Institute for Clinical Research, Inc.
Chula Vista, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Elite Research Institute
Miami, Florida, United States
Miami Research Associates, Inc.
South Miami, Florida, United States
MRA Clinical Research, LLC
South Miami, Florida, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States
L-MARC Research Center
Louisville, Kentucky, United States
Prism Research
Saint Paul, Minnesota, United States
High Point Clinical Trials Center, LLC
High Point, North Carolina, United States
Carolina Phase 1 Research
Raleigh, North Carolina, United States
Wake Internal Medicine Consultants
Raleigh, North Carolina, United States
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States
Community Research
Cincinnati, Ohio, United States
Mercy Hospital Pharmacy
Cincinnati, Ohio, United States
Covance Clinical Research Unit
Dallas, Texas, United States
Countries
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References
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Kim AM, Somayaji VR, Dong JQ, Rolph TP, Weng Y, Chabot JR, Gropp KE, Talukdar S, Calle RA. Once-weekly administration of a long-acting fibroblast growth factor 21 analogue modulates lipids, bone turnover markers, blood pressure and body weight differently in obese people with hypertriglyceridaemia and in non-human primates. Diabetes Obes Metab. 2017 Dec;19(12):1762-1772. doi: 10.1111/dom.13023. Epub 2017 Jul 21.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B2901011
Identifier Type: -
Identifier Source: org_study_id
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