NCT00785408
Completed
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- AC2307
- Conditions
- Obesity
- Sponsor
- AstraZeneca
- Enrollment
- 273
- Locations
- 1
- Primary Endpoint
- To examine the effect on body weight of AC2307 injected subcutaneously (SC) twice daily (BID) in obese or overweight subjects
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
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
Arms & Interventions
1
Intervention: AC2307
2
Intervention: AC2307
3
Intervention: AC2307
4
Intervention: placebo
5
Intervention: placebo
6
Intervention: placebo
Outcomes
Primary Outcomes
To examine the effect on body weight of AC2307 injected subcutaneously (SC) twice daily (BID) in obese or overweight subjects
Time Frame: 24 weeks
To assess the safety and tolerability of AC2307 injected SC BID in obese or overweight subjects
Time Frame: 24 weeks
Secondary Outcomes
- 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(24 weeks)
- To examine the pharmacokinetics of AC2307 injected SC BID in obese or overweight subjects(24 weeks)
Study Sites (1)
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