Status:
COMPLETED
Study to Examine Safety, Tolerability and Effect on Body Weight of Subcutaneous AC2307 in Obese or Overweight Subjects
Lead Sponsor:
AstraZeneca
Conditions:
Obesity
Overweight
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- \- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
273 Patients enrolled
Trial Details
Trial ID
NCT00785408
Start Date
December 1 2008
End Date
September 1 2009
Last Update
January 19 2015
Active Locations (18)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
Chandler, Arizona, United States
3
Research Site
Santa Rosa, California, United States
4
Research Site
Walnut Creek, California, United States