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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NCT01673178

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Study Location
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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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.

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Type 2 Diabetes MelliutsMultiple Dose Study Of PF-05231023 In Adult Subjects Who Have Poor Lipid Control With And Without Type 2 Diabetes Mellitus
NCT01673178
  1. Anaheim, California
  2. Chula Vista, California
  3. Walnut Creek, California
  4. DeLand, Florida
  5. Miami, Florida
  6. South Miami, Florida
  7. South Miami, Florida
  8. Lexington, Kentucky
  9. Louisville, Kentucky
  10. Saint Paul, Minnesota
  11. High Point, North Carolina
  12. Raleigh, North Carolina
  13. Raleigh, North Carolina
  14. Cincinnati, Ohio
  15. Cincinnati, Ohio
  16. Cincinnati, Ohio
  17. Dallas, Texas
ALL GENDERS
30 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Multiple Dose Study Of PF-05231023 In Adult Subjects Who Have Poor Lipid Control With And Without Type 2 Diabetes Mellitus
Official Title  ICMJE 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
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Melliuts, Type 2
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2013)		107
Original Estimated Enrollment  ICMJE
 (submitted: August 22, 2012)		100
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01673178
Other Study ID Numbers  ICMJE B2901011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP