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

June 10, 2015 updated by: AstraZeneca

Extension Study of Protocol 137OB-201 to Examine the Long Term Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects

This is a long term extension to study 137OB-201 which is designed to examine the effect of pramlintide on body weight and its safety and tolerability in obese subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Chula Vista, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
      • Walnut Creek, California, United States
        • Research Site
    • Florida
      • Miami, Florida, United States
        • Research Site
    • Georgia
      • Augusta, Georgia, United States
        • Research Site
    • Illinois
      • Chicago, Illinois, United States
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States
        • Research Site
    • Kansas
      • Overland Park, Kansas, United States
        • Research Site
    • Louisiana
      • Baton Rouge, Louisiana, United States
        • Research Site
    • Michigan
      • Detroit, Michigan, United States
        • Research Site
    • Minnesota
      • Edina, Minnesota, United States
        • Research Site
    • Missouri
      • St. Louis, Missouri, United States
        • Research Site
    • Montana
      • Butte, Montana, United States
        • Research Site
    • New York
      • New York, New York, United States
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
    • Oregon
      • Portland, Oregon, United States
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States
        • Research Site
    • Washington
      • Olympia, Washington, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject has completed Protocol 137OB-201.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: pramlintide acetate
Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg
Other Names:
  • Symlin
Experimental: 2
Drug: pramlintide acetate
Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg
Other Names:
  • Symlin
Experimental: 3
Drug: pramlintide acetate
Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg
Other Names:
  • Symlin
Placebo Comparator: 4
Drug: placebo
subcutaneous injection, three times a day, volumes equivalent to 120mcg, 240mcg, or 360mcg of pramlintide acetate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Examine the long-term effect of subcutaneously (SC) injected pramlintide on body weight in obese subjects.
Time Frame: open ended
open ended
Examine the long-term safety and tolerability of SC injected pramlintide in obese subjects.
Time Frame: open ended
open ended

Secondary Outcome Measures

Outcome Measure
Time Frame
Investigate the long-term effect of SC injected pramlintide in obese subjects on various anthropometric and pharmacodynamic parameters.
Time Frame: open ended
open ended

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

June 11, 2015

Last Update Submitted That Met QC Criteria

June 10, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 137OB-201E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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