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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Page 1 of 5 (18 locations)

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