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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00402077
• Other study ID #: AFA203
• Status: Completed
• Phase: Phase 2
• First received: November 17, 2006
• Last updated: March 5, 2015
• Start date: November 2006
• Est. completion date: August 2007

Study information

• Verified date: February 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight

Intervention

Drug:
• pramlintide acetate
subcutaneous injection, three times a day, 120mcg
• sibutramine
oral tablet, once a day, 10mg
• phentermine
oral tablet, once a day, 37.5mg
• placebo
subcutaneous injection, three times a day

Locations

Country	Name	City	State
United States	Research Site	Austin	Texas
United States	Research Site	Birmingham	Alabama
United States	Research Site	Chula Vista	California
United States	Research Site	Eugene	Oregon
United States	Research Site	La Jolla	California
United States	Research Site	Los Angeles	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	Miami	Florida
United States	Research Site	New York	New York
United States	Research Site	Pembroke Pines	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Raleigh	North Carolina
United States	Research Site	San Antonio	Texas
United States	Research Site	Statesville	North Carolina
United States	Research Site	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All treatment-emergent adverse events occurring during the 24-week treatment period		24 weeks	No
Primary	Absolute change in body weight from baseline to Week 12		12 weeks	No
Secondary	Percent change in body weight from baseline to Week 12		12 weeks	No
Secondary	Percentage of subjects achieving at least 5% weight loss from baseline to Week 12 and Week 24		24 weeks	No
Secondary	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	No
Secondary	Absolute changes in anthropometric measurements (hip and waist circumferences) from baseline to Week 12 and Week 24		24 weeks	No
Secondary	Changes in fasting serum concentrations of lipids from baseline to Week 12 and Week 24		24 weeks	No
Secondary	Changes in summary measures derived from patient reported outcome questionnaires from baseline to Week 12 and Week 24		24 weeks	No
Secondary	Changes in individual item responses from patient reported outcome questionnaires from baseline to Week 12 and Week 24		24 weeks	No