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

Completed · Phase 2 · Has a placebo group

Conditions studied: Obesity, Overweight

In brief

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.

Key facts

Study ID

NCT00785408

Run by

AstraZeneca

People needed

273

Starts

2008-12-01

Expected to finish

2009-09-01

Last updated by the study team

2015-01-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Research Site — Birmingham, Alabama, United States
• Research Site — Chandler, Arizona, United States
• Research Site — Santa Rosa, California, United States
• Research Site — Walnut Creek, California, United States
• Research Site — Denver, Colorado, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Overland Park, Kansas, United States
• Research Site — Baton Rouge, Louisiana, United States
• Research Site — Butte, Montana, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Eugene, Oregon, United States
• Research Site — Medford, Oregon, United States
• Research Site — Greer, South Carolina, United States
• Research Site — Mt. Pleasant, South Carolina, United States
• Research Site — Austin, Texas, United States
• Research Site — Olympia, Washington, United States

Full record on ClinicalTrials.gov

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