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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