A Study to Examine the 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:

NCT00112021

First received: May 27, 2005

Last updated: April 9, 2015

Last verified: April 2015

History of Changes

Purpose

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

Condition	Intervention	Phase
Obesity	Drug: pramlintide acetate	Phase 2


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

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:

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 Outcome Measures:

To investigate the effect of pramlintide in obese subjects on anthropometric and fasting/postprandial humoral metabolic parameters [ Time Frame: Approximately 16 weeks ]


Enrollment:	400
Study Start Date:	May 2005
Study Completion Date:	November 2005
Primary Completion Date:	November 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pramlintide Acetate	Drug: pramlintide acetate Other Name: Pramlintide acetate injection (Pramlintide (0.6 mg/mL)) is a clear, colorless, sterile solution for SC injection
Placebo Comparator: Placebo

Eligibility


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

Criteria

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.

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: NCT00112021

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:	NCT00112021 History of Changes
Other Study ID Numbers:	137OB-201
Study First Received:	May 27, 2005
Last Updated:	April 9, 2015
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:


obesity weight loss Amylin pramlintide Symlin

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 30, 2016

To Top