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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00112021
First received: May 27, 2005
Last updated: September 18, 2013
Last verified: September 2013

May 27, 2005
September 18, 2013
May 2005
November 2005   (final data collection date for primary outcome measure)
  • To examine the effect of pramlintide on body weight in obese subjects
  • To examine the safety and tolerability of pramlintide in obese subjects
Same as current
Complete list of historical versions of study NCT00112021 on ClinicalTrials.gov Archive Site
To investigate the effect of pramlintide in obese subjects on anthropometric and fasting/postprandial humoral metabolic parameters
Same as current
Not Provided
Not Provided
 
A Study to Examine the Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects
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

This is a study to examine the effect of pramlintide on body weight and its safety and tolerability in obese subjects.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Obesity
Drug: pramlintide acetate
Not Provided
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. Epub 2008 Jun 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
Not Provided
November 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00112021
137OB-201
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
Bristol-Myers Squibb
September 2013

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