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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 March 2015
• Main ID: NCT00402077
• Date of registration: 17/11/2006
• Prospective Registration: No
• Primary sponsor: AstraZeneca
• Public title: 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
• Scientific 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
• Date of first enrolment: November 2006
• Target sample size: 258
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00402077
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Lisa Porter, MD
• Affiliation: Amylin Pharmaceuticals, LLC.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Obesity

Overweight

Intervention(s)

Drug: placebo

Drug: sibutramine

Drug: phentermine

Drug: pramlintide acetate

Primary Outcome(s)

All treatment-emergent adverse events occurring during the 24-week treatment period [Time Frame: 24 weeks]

Absolute change in body weight from baseline to Week 12 [Time Frame: 12 weeks]

Secondary Outcome(s)

Percent change in body weight from baseline to Week 12 [Time Frame: 12 weeks]

Absolute changes in anthropometric measurements (hip and waist circumferences) from baseline to Week 12 and Week 24 [Time Frame: 24 weeks]

Changes in summary measures derived from patient reported outcome questionnaires from baseline to Week 12 and Week 24 [Time Frame: 24 weeks]

Percentage of subjects achieving at least 5% weight loss from baseline to Week 12 and Week 24 [Time Frame: 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 [Time Frame: 24 weeks]

Changes in fasting serum concentrations of lipids from baseline to Week 12 and Week 24 [Time Frame: 24 weeks]

Changes in individual item responses from patient reported outcome questionnaires from baseline to Week 12 and Week 24 [Time Frame: 24 weeks]

Secondary ID(s)

AFA203

Source(s) of Monetary Support

Please refer to primary and secondary sponsors