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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00785408
• Other study ID #: CFA104
• Status: Completed
• Phase: Phase 2
• First received: November 4, 2008
• Last updated: January 16, 2015
• Start date: December 2008
• Est. completion date: September 2009

Study information

• Verified date: December 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight

Intervention

Drug:
• AC2307
subcutaneous, twice daily, low dose
• placebo
subcutaneous, twice daily, low dose
• AC2307
subcutaneous, twice daily, middle dose
• placebo
subcutaneous, twice daily, middle dose
• AC2307
subcutaneous, twice daily, high dose
• placebo
subcutaneous, twice daily, high dose

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To examine the effect on body weight of AC2307 injected subcutaneously (SC) twice daily (BID) in obese or overweight subjects		24 weeks	No
Primary	To assess the safety and tolerability of AC2307 injected SC BID in obese or overweight subjects		24 weeks	No
Secondary	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	No
Secondary	To examine the pharmacokinetics of AC2307 injected SC BID in obese or overweight subjects		24 weeks	No