A Study to Examine the Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00112021
• Other study ID #: 137OB-201
• Status: Completed
• Phase: Phase 2
• First received: May 27, 2005
• Last updated: April 9, 2015
• Start date: May 2005
• Est. completion date: November 2005

Study information

• Verified date: April 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a study to examine the effect of pramlintide on body weight and its safety and tolerability in obese subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Obesity

Intervention

Drug:
• pramlintide acetate

Locations

Country	Name	City	State
United States	Research Site	Augusta	Georgia
United States	Research Site	Austin	Texas
United States	Research Site	Baton Rouge	Louisiana
United States	Research Site	Butte	Montana
United States	Research Site	Chicago	Illinois
United States	Research Site	Chula Vista	California
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Detroit	Michigan
United States	Research Site	Edina	Minnesota
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Miami	Florida
United States	Research Site	New York	New York
United States	Research Site	Olympia	Washington
United States	Research Site	Overland Park	Kansas
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Portland	Oregon
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	St. Louis	Missouri
United States	Research Site	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To examine the effect of pramlintide on body weight in obese subjects		Approximately 16 weeks
Primary	To examine the safety and tolerability of pramlintide in obese subjects		Approximately 16 weeks
Secondary	To investigate the effect of pramlintide in obese subjects on anthropometric and fasting/postprandial humoral metabolic parameters		Approximately 16 weeks