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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00189514

First received: September 12, 2005

Last updated: June 10, 2015

Last verified: May 2015

History of Changes

Purpose

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.

Condition	Intervention	Phase
Obesity	Drug: pramlintide acetate Drug: placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Body Weight

Drug Information available for: Pramlintide Pramlintide acetate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Examine the long-term effect of subcutaneously (SC) injected pramlintide on body weight in obese subjects. [ Time Frame: open ended ] [ Designated as safety issue: No ]
Examine the long-term safety and tolerability of SC injected pramlintide in obese subjects. [ Time Frame: open ended ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Investigate the long-term effect of SC injected pramlintide in obese subjects on various anthropometric and pharmacodynamic parameters. [ Time Frame: open ended ] [ Designated as safety issue: No ]


Enrollment:	210
Study Start Date:	September 2005
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: pramlintide acetate Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg Other Name: Symlin
Experimental: 2	Drug: pramlintide acetate Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg Other Name: Symlin
Experimental: 3	Drug: pramlintide acetate Subcutaneous injection, twice a day or three times a day, at doses of 120mcg, 240mcg, or 360mcg Other Name: Symlin
Placebo Comparator: 4	Drug: placebo subcutaneous injection, three times a day, volumes equivalent to 120mcg, 240mcg, or 360mcg of pramlintide acetate

Eligibility


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject has completed Protocol 137OB-201.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189514

Show 21 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	Lisa Porter, MD	Amylin Pharmaceuticals, LLC.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Smith SR, Aronne LJ, Burns CM, Kesty NC, Halseth AE, Weyer C. Sustained weight loss following 12-month pramlintide treatment as an adjunct to lifestyle intervention in obesity. Diabetes Care. 2008 Sep;31(9):1816-23. doi: 10.2337/dc08-0029. Epub 2008 Jun 20.


Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00189514 History of Changes
Other Study ID Numbers:	137OB-201E
Study First Received:	September 12, 2005
Last Updated:	June 10, 2015
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:


obesity weight loss Amylin pramlintide

Additional relevant MeSH terms:


Body Weight Signs and Symptoms Pramlintide Islet Amyloid Polypeptide Hypoglycemic Agents	Physiological Effects of Drugs Appetite Depressants Anti-Obesity Agents Amylin Receptor Agonists Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2016

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