A Study to Examine the Safety, Tolerability, and Body Weight Effect of Pramlintide Alone and in Combination With Oral Antiobesity Agents in Overweight and Obese Subjects - Full Text View

Sponsored by:	Amylin Pharmaceuticals, Inc.
Information provided by:	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00402077

Purpose

This study will examine the safety, tolerability, and body weight effect of subcutaneous pramlintide alone and in various combinations with the oral antiobesity agents sibutramine or phentermine in overweight and obese subjects.

Condition	Intervention	Phase
Overweight Obesity	Drug: pramlintide acetate Drug: sibutramine Drug: phentermine Drug: placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Parallel-Group, Multicenter Study to Examine the Safety, Tolerability, and Body Weight Effect of Subcutaneous Pramlintide Alone and in Combination With the Oral Antiobesity Agents Sibutramine or Phentermine in Overweight and Obese Subjects

Resource links provided by NLM:

MedlinePlus related topics: Obesity

Drug Information available for: Sibutramine Sibutramine hydrochloride monohydrate Pramlintide Pramlintide acetate Phentermine Phentermine hydrochloride

U.S. FDA Resources

Further study details as provided by Amylin Pharmaceuticals, Inc.:

Primary Outcome Measures:

All treatment-emergent adverse events occurring during the 24-week treatment period [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Absolute change in body weight from baseline to Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent change in body weight from baseline to Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percentage of subjects achieving at least 5% weight loss from baseline to Week 12 and Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Absolute and percent changes in body weight from baseline to Week 2, Week 4, Week 8, Week 16, Week 20, and Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Absolute changes in anthropometric measurements (hip and waist circumferences) from baseline to Week 12 and Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Changes in fasting serum concentrations of lipids from baseline to Week 12 and Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Changes in summary measures derived from patient reported outcome questionnaires from baseline to Week 12 and Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Changes in individual item responses from patient reported outcome questionnaires from baseline to Week 12 and Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	258
Study Start Date:	November 2006
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: pramlintide acetate subcutaneous injection, three times a day, 120mcg
2: Experimental	Drug: pramlintide acetate subcutaneous injection, three times a day, 120mcg Drug: sibutramine oral tablet, once a day, 10mg
3: Experimental	Drug: pramlintide acetate subcutaneous injection, three times a day, 120mcg Drug: phentermine oral tablet, once a day, 37.5mg
4: Placebo Comparator	Drug: placebo subcutaneous injection, three times a day

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
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 or overweight with a BMI >=27 kg/m^2 in the presence of other risk factors (e.g., hyperlipidemia, sleep apnea, or treatment for these conditions)
Has been obese or overweight for at least one year prior to study start
Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start: *hormone replacement therapy; *oral contraceptives; *lipid-lowering agents; *thyroid replacement therapy; *metformin

Exclusion Criteria:

Is currently enrolled in or is planning to enroll in a formal weight-loss program
Is unwilling or unable to participate in a lifestyle intervention program as part of the study
Has been treated (within the 2 months prior to study start), is currently treated, or is expected to require or undergo treatment with any of the following excluded medications: *prescription or over the counter antiobesity agents (within the 6 months prior to study start);
- psychotropic/neurological agents (i.e., antipsychotic, antiepileptic, antidepressant, or antianxiety agents, or mood stabilizers); *steroids that are known to result in high systemic absorption; *calcitonin; *ketoconazole; *antidiabetic medications
Has had liposuction, abdominoplasty, or a similar procedure within 1 year before study start or is planning to have such a procedure during the study
Has received any investigational drug within 1 month (or 5 half-lives of investigational drug, whichever is greater) before study start
Has previously used pramlintide either by prescription or as part of a clinical study
Has used sibutramine or phentermine (either by prescription or as part of a clinical study) within 2 years before study start
Has donated blood within 2 months before study start, or is planning to donate blood during the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402077

Locations

United States, Alabama
Research Site
Birmingham, Alabama, United States
United States, Arizona
Research Site
Phoenix, Arizona, United States
United States, California
Research Site
Chula Vista, California, United States
Research Site
La Jolla, California, United States
Research Site
Walnut Creek, California, United States
Research Site
Los Angeles, California, United States
United States, Florida
Research Site
Miami, Florida, United States
Research Site
Pembroke Pines, Florida, United States
United States, Kentucky
Research Site
Louisville, Kentucky, United States
United States, New York
Research Site
New York, New York, United States
United States, North Carolina
Research Site
Raleigh, North Carolina, United States
Research Site
Statesville, North Carolina, United States
United States, Oregon
Research Site
Eugene, Oregon, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
United States, Texas
Research Site
Austin, Texas, United States
Research Site
San Antonio, Texas, United States

Sponsors and Collaborators

Amylin Pharmaceuticals, Inc.

Investigators

Study Director:

Lisa Porter, MD

Amylin Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Amylin Pharmaceuticals ( Lisa Porter, MD, Study Director )
Study ID Numbers:	AFA203
Study First Received:	November 17, 2006
Last Updated:	January 8, 2008
ClinicalTrials.gov Identifier:	NCT00402077 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, Inc.:

overweight
obesity
pramlintide
Symlin

sibutramine
Meridia
phentermine
Amylin

Study placed in the following topic categories:

Obesity
Neurotransmitter Agents
Adrenergic Agents
Amylin
Psychotropic Drugs
Overweight
Central Nervous System Stimulants
Phentermine
Body Weight
Sibutramine

Signs and Symptoms
Anti-Obesity Agents
Hypoglycemic Agents
Nutrition Disorders
Appetite Depressants
Overnutrition
Pramlintide
Peripheral Nervous System Agents
Antidepressive Agents

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Overweight
Sibutramine
Body Weight
Signs and Symptoms
Hypoglycemic Agents
Therapeutic Uses
Nutrition Disorders
Appetite Depressants

Pramlintide
Antidepressive Agents
Obesity
Sympathomimetics
Central Nervous System Stimulants
Pharmacologic Actions
Phentermine
Anti-Obesity Agents
Autonomic Agents
Overnutrition
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009