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A Study to Examine the Safety, Tolerability, and Body Weight Effect of Pramlintide Alone and in Combination With Oral Antiobesity Agents in Overweight and Obese Subjects

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
pramlintide acetate
sibutramine
phentermine
placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring overweight, obesity, pramlintide, Symlin, sibutramine, Meridia, phentermine, Amylin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Is obese with a Body Mass Index (BMI) >=30 kg/m^2 to <=50 kg/m^2 or overweight with a BMI >=27 kg/m^2 in the presence of other risk factors (e.g., hyperlipidemia, sleep apnea, or treatment for these conditions)
  • Has been obese or overweight for at least one year prior to study start
  • Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start: *hormone replacement therapy; *oral contraceptives; *lipid-lowering agents; *thyroid replacement therapy; *metformin

Exclusion Criteria:

  • Is currently enrolled in or is planning to enroll in a formal weight-loss program
  • Is unwilling or unable to participate in a lifestyle intervention program as part of the study
  • Has been treated (within the 2 months prior to study start), is currently treated, or is expected to require or undergo treatment with any of the following excluded medications: *prescription or over the counter antiobesity agents (within the 6 months prior to study start); *psychotropic/neurological agents (i.e., antipsychotic, antiepileptic, antidepressant, or antianxiety agents, or mood stabilizers); *steroids that are known to result in high systemic absorption; *calcitonin; *ketoconazole; *antidiabetic medications
  • Has had liposuction, abdominoplasty, or a similar procedure within 1 year before study start or is planning to have such a procedure during the study
  • Has received any investigational drug within 1 month (or 5 half-lives of investigational drug, whichever is greater) before study start
  • Has previously used pramlintide either by prescription or as part of a clinical study
  • Has used sibutramine or phentermine (either by prescription or as part of a clinical study) within 2 years before study start
  • Has donated blood within 2 months before study start, or is planning to donate blood during the study

Sites / Locations

  • Research Site
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  • Research Site
  • Research Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

All treatment-emergent adverse events occurring during the 24-week treatment period
Absolute change in body weight from baseline to Week 12

Secondary Outcome Measures

Percent change in body weight from baseline to Week 12
Percentage of subjects achieving at least 5% weight loss from baseline to Week 12 and Week 24
Absolute and percent changes in body weight from baseline to Week 2, Week 4, Week 8, Week 16, Week 20, and Week 24
Absolute changes in anthropometric measurements (hip and waist circumferences) from baseline to Week 12 and Week 24
Changes in fasting serum concentrations of lipids from baseline to Week 12 and Week 24
Changes in summary measures derived from patient reported outcome questionnaires from baseline to Week 12 and Week 24
Changes in individual item responses from patient reported outcome questionnaires from baseline to Week 12 and Week 24

Full Information

First Posted
November 17, 2006
Last Updated
March 5, 2015
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00402077
Brief Title
A Study to Examine the Safety, Tolerability, and Body Weight Effect of Pramlintide Alone and in Combination With Oral Antiobesity Agents in Overweight and Obese Subjects
Official Title
A Randomized, Parallel-Group, Multicenter Study to Examine the Safety, Tolerability, and Body Weight Effect of Subcutaneous Pramlintide Alone and in Combination With the Oral Antiobesity Agents Sibutramine or Phentermine in Overweight and Obese Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will examine the safety, tolerability, and body weight effect of subcutaneous pramlintide alone and in various combinations with the oral antiobesity agents sibutramine or phentermine in overweight and obese subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
overweight, obesity, pramlintide, Symlin, sibutramine, Meridia, phentermine, Amylin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
258 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
pramlintide acetate
Other Intervention Name(s)
Symlin
Intervention Description
subcutaneous injection, three times a day, 120mcg
Intervention Type
Drug
Intervention Name(s)
sibutramine
Other Intervention Name(s)
Meridia
Intervention Description
oral tablet, once a day, 10mg
Intervention Type
Drug
Intervention Name(s)
phentermine
Other Intervention Name(s)
Adipex-P, Fastin, Obenix, Oby-Trim
Intervention Description
oral tablet, once a day, 37.5mg
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
subcutaneous injection, three times a day
Primary Outcome Measure Information:
Title
All treatment-emergent adverse events occurring during the 24-week treatment period
Time Frame
24 weeks
Title
Absolute change in body weight from baseline to Week 12
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Percent change in body weight from baseline to Week 12
Time Frame
12 weeks
Title
Percentage of subjects achieving at least 5% weight loss from baseline to Week 12 and Week 24
Time Frame
24 weeks
Title
Absolute and percent changes in body weight from baseline to Week 2, Week 4, Week 8, Week 16, Week 20, and Week 24
Time Frame
24 weeks
Title
Absolute changes in anthropometric measurements (hip and waist circumferences) from baseline to Week 12 and Week 24
Time Frame
24 weeks
Title
Changes in fasting serum concentrations of lipids from baseline to Week 12 and Week 24
Time Frame
24 weeks
Title
Changes in summary measures derived from patient reported outcome questionnaires from baseline to Week 12 and Week 24
Time Frame
24 weeks
Title
Changes in individual item responses from patient reported outcome questionnaires from baseline to Week 12 and Week 24
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is obese with a Body Mass Index (BMI) >=30 kg/m^2 to <=50 kg/m^2 or overweight with a BMI >=27 kg/m^2 in the presence of other risk factors (e.g., hyperlipidemia, sleep apnea, or treatment for these conditions) Has been obese or overweight for at least one year prior to study start Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start: *hormone replacement therapy; *oral contraceptives; *lipid-lowering agents; *thyroid replacement therapy; *metformin Exclusion Criteria: Is currently enrolled in or is planning to enroll in a formal weight-loss program Is unwilling or unable to participate in a lifestyle intervention program as part of the study Has been treated (within the 2 months prior to study start), is currently treated, or is expected to require or undergo treatment with any of the following excluded medications: *prescription or over the counter antiobesity agents (within the 6 months prior to study start); *psychotropic/neurological agents (i.e., antipsychotic, antiepileptic, antidepressant, or antianxiety agents, or mood stabilizers); *steroids that are known to result in high systemic absorption; *calcitonin; *ketoconazole; *antidiabetic medications Has had liposuction, abdominoplasty, or a similar procedure within 1 year before study start or is planning to have such a procedure during the study Has received any investigational drug within 1 month (or 5 half-lives of investigational drug, whichever is greater) before study start Has previously used pramlintide either by prescription or as part of a clinical study Has used sibutramine or phentermine (either by prescription or as part of a clinical study) within 2 years before study start Has donated blood within 2 months before study start, or is planning to donate blood during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Porter, MD
Organizational Affiliation
Amylin Pharmaceuticals, LLC.
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Chula Vista
State/Province
California
Country
United States
Facility Name
Research Site
City
La Jolla
State/Province
California
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Research Site
City
Walnut Creek
State/Province
California
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Pembroke Pines
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
Country
United States
Facility Name
Research Site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Statesville
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Eugene
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study to Examine the Safety, Tolerability, and Body Weight Effect of Pramlintide Alone and in Combination With Oral Antiobesity Agents in Overweight and Obese Subjects

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