Clinical trial NCT00402077: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overweight
Obesity
Keywords: overweight
obesity
pramlintide
Symlin
sibutramine
Meridia
phentermine
Amylin
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-11-22
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: All treatment-emergent adverse events occurring during the 24-week treatment period
timeFrame: 24 weeks
measure: Absolute change in body weight from baseline to Week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: Percent change in body weight from baseline to Week 12
timeFrame: 12 weeks
measure: Percentage of subjects achieving at least 5% weight loss from baseline to Week 12 and Week 24
timeFrame: 24 weeks
measure: Absolute and percent changes in body weight from baseline to Week 2, Week 4, Week 8, Week 16, Week 20, and Week 24
timeFrame: 24 weeks
measure: Absolute changes in anthropometric measurements (hip and waist circumferences) from baseline to Week 12 and Week 24
timeFrame: 24 weeks
measure: Changes in fasting serum concentrations of lipids from baseline to Week 12 and Week 24
timeFrame: 24 weeks
measure: Changes in summary measures derived from patient reported outcome questionnaires from baseline to Week 12 and Week 24
timeFrame: 24 weeks
measure: Changes in individual item responses from patient reported outcome questionnaires from baseline to Week 12 and Week 24
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Chula Vista
country: United States
facility: Research Site
state: California
city: La Jolla
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Walnut Creek
country: United States
facility: Research Site
state: California
city: Miami
country: United States
facility: Research Site
state: Florida
city: Pembroke Pines
country: United States
facility: Research Site
state: Florida
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: New York
country: United States
facility: Research Site
state: New York
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Statesville
country: United States
facility: Research Site
state: North Carolina
city: Eugene
country: United States
facility: Research Site
state: Oregon
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Austin
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: Amylin Pharmaceuticals, LLC.
name: Lisa Porter, MD
role: STUDY_DIRECTOR
References: