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
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
1 other identifier
interventional
258
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2006
Shorter than P25 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 17, 2006
CompletedFirst Posted
Study publicly available on registry
November 22, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedMarch 6, 2015
February 1, 2015
9 months
November 17, 2006
March 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
All treatment-emergent adverse events occurring during the 24-week treatment period
24 weeks
Absolute change in body weight from baseline to Week 12
12 weeks
Secondary Outcomes (7)
Percent change in body weight from baseline to Week 12
12 weeks
Percentage of subjects achieving at least 5% weight loss from baseline to Week 12 and Week 24
24 weeks
Absolute and percent changes in body weight from baseline to Week 2, Week 4, Week 8, Week 16, Week 20, and Week 24
24 weeks
Absolute changes in anthropometric measurements (hip and waist circumferences) from baseline to Week 12 and Week 24
24 weeks
Changes in fasting serum concentrations of lipids from baseline to Week 12 and Week 24
24 weeks
- +2 more secondary outcomes
Study Arms (4)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTAL4
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (16)
Research Site
Birmingham, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Chula Vista, California, United States
Research Site
La Jolla, California, United States
Research Site
Los Angeles, California, United States
Research Site
Walnut Creek, California, United States
Research Site
Miami, Florida, United States
Research Site
Pembroke Pines, Florida, United States
Research Site
Louisville, Kentucky, United States
Research Site
New York, New York, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Statesville, North Carolina, United States
Research Site
Eugene, Oregon, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Austin, Texas, United States
Research Site
San Antonio, Texas, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lisa Porter, MD
Amylin Pharmaceuticals, LLC.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2006
First Posted
November 22, 2006
Study Start
November 1, 2006
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
March 6, 2015
Record last verified: 2015-02