Back to resultsStudy to Examine Safety, Tolerability and Effect on Body Weight of Subcutaneous AC2307 in Obese or Overweight Subjects
Primary Purpose
Obesity, Overweight
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AC2307
placebo
AC2307
placebo
AC2307
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring obesity, overweight, weight loss, Amylin, AC2307
Eligibility 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
Sites / Locations
- Research Site
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Placebo Comparator
Arm Label
1
2
3
4
5
6
Arm Description
Outcomes
Primary Outcome Measures
To examine the effect on body weight of AC2307 injected subcutaneously (SC) twice daily (BID) in obese or overweight subjects
To assess the safety and tolerability of AC2307 injected SC BID in obese or overweight subjects
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
To examine the pharmacokinetics of AC2307 injected SC BID in obese or overweight subjects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00785408
Brief Title
Study to Examine Safety, Tolerability and Effect on Body Weight of Subcutaneous AC2307 in Obese or Overweight Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
obesity, overweight, weight loss, Amylin, AC2307
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
273 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Placebo Comparator
Arm Title
5
Arm Type
Placebo Comparator
Arm Title
6
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AC2307
Intervention Description
subcutaneous, twice daily, low dose
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
subcutaneous, twice daily, low dose
Intervention Type
Drug
Intervention Name(s)
AC2307
Intervention Description
subcutaneous, twice daily, middle dose
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
subcutaneous, twice daily, middle dose
Intervention Type
Drug
Intervention Name(s)
AC2307
Intervention Description
subcutaneous, twice daily, high dose
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
subcutaneous, twice daily, high dose
Primary Outcome Measure Information:
Title
To examine the effect on body weight of AC2307 injected subcutaneously (SC) twice daily (BID) in obese or overweight subjects
Time Frame
24 weeks
Title
To assess the safety and tolerability of AC2307 injected SC BID in obese or overweight subjects
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
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
Title
To examine the pharmacokinetics of AC2307 injected SC BID in obese or overweight subjects
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hubert Chen, MD
Organizational Affiliation
Amylin Pharmaceuticals, LLC.
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Chandler
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Santa Rosa
State/Province
California
Country
United States
Facility Name
Research Site
City
Walnut Creek
State/Province
California
Country
United States
Facility Name
Research Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Overland Park
State/Province
Kansas
Country
United States
Facility Name
Research Site
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Butte
State/Province
Montana
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Eugene
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Medford
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Greer
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Mt. Pleasant
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Olympia
State/Province
Washington
Country
United States
12. IPD Sharing Statement
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Study to Examine Safety, Tolerability and Effect on Body Weight of Subcutaneous AC2307 in Obese or Overweight Subjects
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