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Completed

NCT Number: NCT00189514

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

This is a long term extension to study 137OB-201 which is designed to examine the effect of pramlintide on body weight and its safety and tolerability in obese subjects.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Chula Vista, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject has completed Protocol 137OB-201.

Treatment and study plan

Pramlintide acetate

Drug

Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg

Other names: Symlin

Placebo

Drug

subcutaneous injection, three times a day, volumes equivalent to 120mcg, 240mcg, or 360mcg of pramlintide acetate

Primary outcomes

  1. Examine the long-term effect of subcutaneously (SC) injected pramlintide on body weight in obese subjects.

    Time frame: open ended

  2. Examine the long-term safety and tolerability of SC injected pramlintide in obese subjects.

    Time frame: open ended

Secondary outcomes

  1. Investigate the long-term effect of SC injected pramlintide in obese subjects on various anthropometric and pharmacodynamic parameters.

    Time frame: open ended

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Extension Study of Protocol 137OB-201 to Examine the Long Term Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 19, 2005
Registry last updated
Jun 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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