A Study to Examine the Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects
Overview
This is a study to examine the effect of pramlintide on body weight and its safety and tolerability in obese subjects.
Full Title of Study: “A Phase 2B, Randomized, Double-Blinded, Placebo-Controlled, Dose Ranging, Multicenter Study to Examine the Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double
- Study Primary Completion Date: November 2005
Interventions
- Drug: pramlintide acetate
Arms, Groups and Cohorts
- Experimental: Pramlintide Acetate
- Placebo Comparator: Placebo
Clinical Trial Outcome Measures
Primary Measures
- To examine the effect of pramlintide on body weight in obese subjects
- Time Frame: Approximately 16 weeks
- To examine the safety and tolerability of pramlintide in obese subjects
- Time Frame: Approximately 16 weeks
Secondary Measures
- To investigate the effect of pramlintide in obese subjects on anthropometric and fasting/postprandial humoral metabolic parameters
- Time Frame: Approximately 16 weeks
Participating in This Clinical Trial
Inclusion Criteria
- Is obese with a body mass index (BMI) >=30 kg/m^2 to <=50 kg/m^2, and has been obese for at least one year before screening. – Usually consumes at least three major meals (morning, midday, and evening) each day. Exclusion Criteria:
- Is currently enrolled in a formal weight-loss program. – Has had liposuction within 1 year before screening or is planning to have liposuction during the study. – Has received any investigational drug within 3 months before screening. – Has previously participated in a study using pramlintide.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 70 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- AstraZeneca
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Lisa Porter, MD, Study Director, Amylin Pharmaceuticals, LLC.
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