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Multiple Dose Study Of PF-05231023 In Adult Subjects Who Have Poor Lipid Control With And Without Type 2 Diabetes Mellitus

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Anaheim Clinical Trials, LLC
Anaheim, California, 92801 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Melliuts
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
30-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male and female subjects of non-childbearing potential between the ages of 30 and 70
years with and without a diagnosis of Type 2 diabetes mellitus (according to the
American Diabetes Association guidelines).

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding asymptomatic, seasonal
allergies at time of dosing).

- 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.

NCT01673178
Pfizer
Completed
Multiple Dose Study Of PF-05231023 In Adult Subjects Who Have Poor Lipid Control With And Without Type 2 Diabetes Mellitus

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[email protected]

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Multiple Dose Study Of PF-05231023 In Adult Subjects Who Have Poor Lipid Control With And Without Type 2 Diabetes Mellitus
A Phase 1, Placebo-controlled, Randomized Trial To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Iv Doses Of Pf-05231023 In Obese Hyperlipidemic Adult Subjects With And Without Type 2 Diabetes Mellitus On A Background Of Atorvastatin
This is a trial in obese subjects who have poor lipid control with and without Type 2 diabetes mellitus to study the safety, tolerability and pharmacokinetics of multiple doses of PF-05231023
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Melliuts, Type 2
  • Other: Placebo
    0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), once a week for 4 weeks
  • Drug: 25 mg PF-05231023
    25 mg IV once a week for 4 weeks
  • Drug: 50 mg PF-05231023
    50 mg IV once a week for 4 weeks
  • Drug: 100 mg PF-05231023
    100 mg IV once a week for 4 weeks
  • Drug: 150 mg PF-05231023
    150 mg IV once a week for 4 weeks
  • Placebo Comparator: Placebo Arm
    Intervention: Other: Placebo
  • Experimental: 25 mg
    Intervention: Drug: 25 mg PF-05231023
  • Experimental: 50 mg
    Intervention: Drug: 50 mg PF-05231023
  • Experimental: 100 mg
    Intervention: Drug: 100 mg PF-05231023
  • Experimental: 150 mg
    Intervention: Drug: 150 mg PF-05231023
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
107
September 2013
August 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female subjects of non-childbearing potential between the ages of 30 and 70 years with and without a diagnosis of Type 2 diabetes mellitus (according to the American Diabetes Association guidelines).
  • 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:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding asymptomatic, seasonal allergies at time of dosing).
  • 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.
Sexes Eligible for Study: All
30 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01673178
B2901011
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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