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

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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

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

Condition or disease Intervention/treatment Phase
Obesity Drug: pramlintide acetate Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : May 2005
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Pramlintide Acetate Drug: pramlintide acetate
Other Name: Pramlintide acetate injection (Pramlintide (0.6 mg/mL)) is a clear, colorless, sterile solution for SC injection
Placebo Comparator: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. To examine the effect of pramlintide on body weight in obese subjects [ Time Frame: Approximately 16 weeks ]
  2. To examine the safety and tolerability of pramlintide in obese subjects [ Time Frame: Approximately 16 weeks ]

Secondary Outcome Measures :
  1. To investigate the effect of pramlintide in obese subjects on anthropometric and fasting/postprandial humoral metabolic parameters [ Time Frame: Approximately 16 weeks ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00112021


  Show 21 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00112021     History of Changes
Other Study ID Numbers: 137OB-201
First Posted: May 30, 2005    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015

Keywords provided by AstraZeneca:
obesity
weight loss
Amylin
pramlintide
Symlin

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms
Pramlintide
Islet Amyloid Polypeptide
Hypoglycemic Agents
 Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Amylin Receptor Agonists
Molecular Mechanisms of Pharmacological Action