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

Phase 2

Completed

• Conditions: Obesity; Overweight
• Interventions: Drug: AC2307; Drug: placebo

• Registration Number: NCT00785408
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-04
• Study First Submitted QC: 2008-11-04
• Study First Posted: 2008-11-05
• Study Start: 2008-12
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2014-12
• Last Update Submitted: 2015-01-16
• Last Update Posted: 2015-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 273

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AC2307	-
3	AC2307	-
4	placebo	-
5	placebo	-
6	placebo	-
2	AC2307	-

Primary Outcome Measures

Name	Time	Method
To examine the effect on body weight of AC2307 injected subcutaneously (SC) twice daily (BID) in obese or overweight subjects	24 weeks
To assess the safety and tolerability of AC2307 injected SC BID in obese or overweight subjects	24 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Olympia, Washington, United States