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

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: May 27, 2005
Last updated: April 9, 2015
Last verified: April 2015
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
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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

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

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


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00112021

  Hide Study Locations
United States, California
Research Site
Chula Vista, California, United States
Research Site
San Diego, California, United States
Research Site
Walnut Creek, California, United States
United States, Florida
Research Site
Miami, Florida, United States
United States, Georgia
Research Site
Augusta, Georgia, United States
United States, Illinois
Research Site
Chicago, Illinois, United States
United States, Indiana
Research Site
Indianapolis, Indiana, United States
United States, Kansas
Research Site
Overland Park, Kansas, United States
United States, Louisiana
Research Site
Baton Rouge, Louisiana, United States
United States, Michigan
Research Site
Detroit, Michigan, United States
United States, Minnesota
Research Site
Edina, Minnesota, United States
United States, Missouri
Research Site
St. Louis, Missouri, United States
United States, Montana
Research Site
Butte, Montana, United States
United States, New York
Research Site
New York, New York, United States
United States, Ohio
Research Site
Cincinnati, Ohio, United States
United States, Oregon
Research Site
Portland, Oregon, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
United States, Texas
Research Site
Austin, Texas, United States
Research Site
San Antonio, Texas, United States
United States, Utah
Research Site
Salt Lake City, Utah, United States
United States, Washington
Research Site
Olympia, Washington, United States
Sponsors and Collaborators
Study Director: Lisa Porter, MD Amylin Pharmaceuticals, LLC.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT00112021     History of Changes
Other Study ID Numbers: 137OB-201
Study First Received: May 27, 2005
Last Updated: April 9, 2015

Keywords provided by AstraZeneca:
weight loss

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms
Islet Amyloid Polypeptide
Hypoglycemic Agents
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Amylin Receptor Agonists
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017