Study to Examine Safety, Tolerability and Effect on Body Weight of Subcutaneous AC2307 in Obese or Overweight Subjects - Full Text View

Sponsored by:	Amylin Pharmaceuticals, Inc.
Information provided by:	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00785408

Purpose

A randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to examine the safety, tolerability, and effect on body weight of subcutaneous AC2307 in obese or overweight subjects.

Condition	Intervention	Phase
Obesity Overweight	Drug: AC2307 Drug: placebo	Phase II

MedlinePlus related topics: Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Examine the Safety, Tolerability, and Effect on Body Weight of Subcutaneous AC2307 in Obese or Overweight Subjects

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

Primary Outcome Measures:

To examine the effect on body weight of AC2307 injected subcutaneously (SC) twice daily (BID) in obese or overweight subjects [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
To assess the safety and tolerability of AC2307 injected SC BID in obese or overweight subjects [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To examine the effect of AC2307 injected SC BID in obese or overweight subjects on the following parameters: waist circumference; gastric emptying rate; fasting circulating metabolic parameters; patient reported outcomes [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
To examine the pharmacokinetics of AC2307 injected SC BID in obese or overweight subjects [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	December 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: AC2307 subcutaneous, twice daily, low dose
2: Experimental	Drug: AC2307 subcutaneous, twice daily, middle dose
3: Experimental	Drug: AC2307 subcutaneous, twice daily, high dose
4: Placebo Comparator	Drug: placebo subcutaneous, twice daily, low dose
5: Placebo Comparator	Drug: placebo subcutaneous, twice daily, middle dose
6: Placebo Comparator	Drug: placebo subcutaneous, twice daily, high dose

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 ≤45 kg/m^2, or is overweight with a BMI ≥27 kg/m^2 to <30 kg/m^2 and has at least one weight-related comorbidity (dyslipidemia, impaired fasting glucose, hypertension, obstructive sleep apnea syndrome, polycystic ovary syndrome, and/or osteoarthritis)

Exclusion Criteria:

Has had a major change in daily physical activity (e.g., initiation of an exercise program) or has been enrolled in a weight loss program within 2 months prior to study start
Has received AC2307 or pramlintide in a clinical study or has received prior treatment with pramlintide (SYMLIN®) or calcitonin
Has received any investigational drug within 1 month or within a period corresponding to five times the half-life of the investigational drug, whichever is greater, 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: NCT00785408

Contacts

Contact: Amylin Call Center

800-349-8919

clinicaltrials@amylin.com

Locations

United States, Alabama
Research Site	Not yet recruiting
Birmingham, Alabama, United States
Contact: Amylin Call Center 800-349-8919
United States, Arizona
Research Site	Not yet recruiting
Chandler, Arizona, United States
Contact: Amylin Call Center 800-349-8919
United States, California
Research Site	Not yet recruiting
Santa Rosa, California, United States
Contact: Amylin Call Center 800-349-8919
Research Site	Recruiting
Walnut Creek, California, United States
Contact: Amylin Call Center 800-349-8919
United States, Colorado
Research Site	Not yet recruiting
Denver, Colorado, United States
Contact: Amylin Call Center 800-349-8919
United States, Florida
Research Site	Not yet recruiting
Jacksonville, Florida, United States
Contact: Amylin Call Center 800-349-8919
Research Site	Not yet recruiting
Miami, Florida, United States
Contact: Amylin Call Center 800-349-8919
United States, Illinois
Research Site	Not yet recruiting
Chicago, Illinois, United States
Contact: Amylin Call Center 800-349-8919
United States, Kansas
Research Site	Not yet recruiting
Overland Park, Kansas, United States
Contact: Amylin Call Center 800-349-8919
United States, Louisiana
Research Site	Not yet recruiting
Baton Rouge, Louisiana, United States
Contact: Amylin Call Center 800-349-8919
United States, Montana
Research Site	Not yet recruiting
Butte, Montana, United States
Contact: Amylin Call Center 800-349-8919
United States, Ohio
Research Site	Not yet recruiting
Cincinnati, Ohio, United States
Contact: Amylin Call Center 800-349-8919
United States, Oregon
Research Site	Not yet recruiting
Medford, Oregon, United States
Contact: Amylin Call Center 800-349-8919
Research Site	Not yet recruiting
Eugene, Oregon, United States
Contact: Amylin Call Center 800-349-8919
United States, South Carolina
Research Site	Not yet recruiting
Mt. Pleasant, South Carolina, United States
Contact: Amylin Call Center 800-349-8919
Research Site	Not yet recruiting
Greer, South Carolina, United States
Contact: Amylin Call Center 800-349-8919
United States, Texas
Research Site	Not yet recruiting
Austin, Texas, United States
Contact: Amylin Call Center 800-349-8919
United States, Washington
Research Site	Not yet recruiting
Olympia, Washington, United States
Contact: Amylin Call Center 800-349-8919

Sponsors and Collaborators

Amylin Pharmaceuticals, Inc.

Investigators

Study Director:

Hubert Chen, MD

Amylin Pharmaceuticals, Inc.

More Information

Responsible Party:	Amylin Pharmaceuticals ( Lisa Porter, MD, VP Clinical Development )
Study ID Numbers:	CFA104
Study First Received:	November 4, 2008
Last Updated:	December 24, 2008
ClinicalTrials.gov Identifier:	NCT00785408
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, Inc.:

obesity
overweight
weight loss
Amylin
AC2307

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Nutrition Disorders
Overnutrition
Overweight

ClinicalTrials.gov processed this record on January 16, 2009