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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00402077

Collaborator

(none)

258

Enrollment

Locations

Arms

Duration (Months)

16.1

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight Obesity	Drug: pramlintide acetate Drug: sibutramine Drug: phentermine Drug: placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

258 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2006

Actual Primary Completion Date :

Aug 1, 2007

Actual Study Completion Date :

Aug 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: pramlintide acetate subcutaneous injection, three times a day, 120mcg Other Names: Symlin
Experimental: 2	Drug: pramlintide acetate subcutaneous injection, three times a day, 120mcg Other Names: Symlin Drug: sibutramine oral tablet, once a day, 10mg Other Names: Meridia
Experimental: 3	Drug: pramlintide acetate subcutaneous injection, three times a day, 120mcg Other Names: Symlin Drug: phentermine oral tablet, once a day, 37.5mg Other Names: Adipex-P Fastin Obenix Oby-Trim
Placebo Comparator: 4	Drug: placebo subcutaneous injection, three times a day

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]
Changes in summary measures derived from patient reported outcome questionnaires from baseline to Week 12 and Week 24 [24 weeks]
Changes in individual item responses from patient reported outcome questionnaires from baseline to Week 12 and Week 24 [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country
1	Research Site	Birmingham	Alabama	United States
2	Research Site	Phoenix	Arizona	United States
3	Research Site	Chula Vista	California	United States
4	Research Site	La Jolla	California	United States
5	Research Site	Los Angeles	California	United States
6	Research Site	Walnut Creek	California	United States
7	Research Site	Miami	Florida	United States
8	Research Site	Pembroke Pines	Florida	United States
9	Research Site	Louisville	Kentucky	United States
10	Research Site	New York	New York	United States
11	Research Site	Raleigh	North Carolina	United States
12	Research Site	Statesville	North Carolina	United States
13	Research Site	Eugene	Oregon	United States
14	Research Site	Philadelphia	Pennsylvania	United States
15	Research Site	Austin	Texas	United States
16	Research Site	San Antonio	Texas	United States