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A Study to Examine the Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00112021
Recruitment Status : Completed
First Posted : May 30, 2005
Last Update Posted : April 10, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE May 27, 2005
First Posted Date  ICMJE May 30, 2005
Last Update Posted Date April 10, 2015
Study Start Date  ICMJE May 2005
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2015)
  • To examine the effect of pramlintide on body weight in obese subjects [ Time Frame: Approximately 16 weeks ]
  • To examine the safety and tolerability of pramlintide in obese subjects [ Time Frame: Approximately 16 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • To examine the effect of pramlintide on body weight in obese subjects
  • To examine the safety and tolerability of pramlintide in obese subjects
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2015)
To investigate the effect of pramlintide in obese subjects on anthropometric and fasting/postprandial humoral metabolic parameters [ Time Frame: Approximately 16 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
To investigate the effect of pramlintide in obese subjects on anthropometric and fasting/postprandial humoral metabolic parameters
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Examine the Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects
Official Title  ICMJE A Phase 2B, Randomized, Double-Blinded, Placebo-Controlled, Dose Ranging, Multicenter Study to Examine the Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects
Brief Summary This is a study to examine the effect of pramlintide on body weight and its safety and tolerability in obese subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE Drug: pramlintide acetate
Other Name: Pramlintide acetate injection (Pramlintide (0.6 mg/mL)) is a clear, colorless, sterile solution for SC injection
Study Arms  ICMJE
  • Experimental: Pramlintide Acetate
    Intervention: Drug: pramlintide acetate
  • Placebo Comparator: Placebo
Publications * Smith SR, Aronne LJ, Burns CM, Kesty NC, Halseth AE, Weyer C. Sustained weight loss following 12-month pramlintide treatment as an adjunct to lifestyle intervention in obesity. Diabetes Care. 2008 Sep;31(9):1816-23. doi: 10.2337/dc08-0029. Epub 2008 Jun 20.

*   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: June 23, 2005)
400
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2005
Actual Primary Completion Date November 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Is obese with a body mass index (BMI) >=30 kg/m^2 to <=50 kg/m^2, and has been obese for at least one year before screening.
  • Usually consumes at least three major meals (morning, midday, and evening) each day.

Exclusion Criteria:

  • Is currently enrolled in a formal weight-loss program.
  • Has had liposuction within 1 year before screening or is planning to have liposuction during the study.
  • Has received any investigational drug within 3 months before screening.
  • Has previously participated in a study using pramlintide.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 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 NCT00112021
Other Study ID Numbers  ICMJE 137OB-201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
PRS Account AstraZeneca
Verification Date April 2015

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