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
  Purpose

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


Condition Intervention Phase
Obesity
Drug: pramlintide acetate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • To examine the effect of pramlintide on body weight in obese subjects
  • To examine the safety and tolerability of pramlintide in obese subjects

Secondary Outcome Measures:
  • To investigate the effect of pramlintide in obese subjects on anthropometric and fasting/postprandial humoral metabolic parameters

Estimated Enrollment: 400
Study Start Date: May 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00112021

  Show 21 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
  More Information

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00112021     History of Changes
Other Study ID Numbers: 137OB-201
Study First Received: May 27, 2005
Last Updated: September 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
obesity
weight loss
Amylin
pramlintide
Symlin

Additional relevant MeSH terms:
Body Weight
Obesity
Signs and Symptoms
Overnutrition
Nutrition Disorders
Overweight
Pramlintide
Islet Amyloid Polypeptide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014