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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Overweight; Obesity

Treatments: Drug: sibutramine; Drug: pramlintide acetate; Drug: phentermine; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00402077

AFA203

Details and patient eligibility

About

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.

Enrollment: 258 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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258 participants in 4 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: pramlintide acetate

2

Experimental group

Treatment:

Drug: sibutramine

Drug: pramlintide acetate

3

Experimental group

Treatment:

Drug: phentermine

Drug: pramlintide acetate

4

Placebo Comparator group

Treatment:

Drug: placebo