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”

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Experimental: 3
• Placebo Comparator: 4

Primary Measures

• All treatment-emergent adverse events occurring during the 24-week treatment period
  • Time Frame: 24 weeks
    Safety Issue?: No
• Absolute change in body weight from baseline to Week 12
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Percent change in body weight from baseline to Week 12
  • Time Frame: 12 weeks
    Safety Issue?: No
• Percentage of subjects achieving at least 5% weight loss from baseline to Week 12 and Week 24
  • Time Frame: 24 weeks
    Safety Issue?: No
• 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
    Safety Issue?: No
• Absolute changes in anthropometric measurements (hip and waist circumferences) from baseline to Week 12 and Week 24
  • Time Frame: 24 weeks
    Safety Issue?: No
• Changes in fasting serum concentrations of lipids from baseline to Week 12 and Week 24
  • Time Frame: 24 weeks
    Safety Issue?: No
• Changes in summary measures derived from patient reported outcome questionnaires from baseline to Week 12 and Week 24
  • Time Frame: 24 weeks
    Safety Issue?: No
• Changes in individual item responses from patient reported outcome questionnaires from baseline to Week 12 and Week 24
  • Time Frame: 24 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Amylin Pharmaceuticals, Inc. Industry

Overall Clinical Trial Officials and Contacts

Lisa Porter, MD Study Director Amylin Pharmaceuticals, Inc.  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00402077

Study ID Number: AFA203

ClinicalTrials.gov Identifier: NCT00402077

Health Authority: United States: Food and Drug Administration