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

Condition(s) targeted: Overweight; Obesity

Intervention: pramlintide acetate (Drug); sibutramine (Drug); phentermine (Drug); placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Amylin Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
Lisa Porter, MD, Study Director, Affiliation: Amylin Pharmaceuticals, Inc.

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.

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 design: Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

All treatment-emergent adverse events occurring during the 24-week treatment period

Absolute change in body weight from baseline to Week 12

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

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, Walnut Creek, California, United States

Research Site, Los Angeles, 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

Starting date: November 2006
Ending date: August 2007
Last updated: January 8, 2008