Clinical trial NCT00785408: Study to Examine Safety, Tolerability and Effect on Body Weight of Subcutaneous AC2307 in Obese or Overweight Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Overweight
Keywords: obesity
overweight
weight loss
Amylin
AC2307
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-11-05
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: To examine the effect on body weight of AC2307 injected subcutaneously (SC) twice daily (BID) in obese or overweight subjects
timeFrame: 24 weeks
measure: To assess the safety and tolerability of AC2307 injected SC BID in obese or overweight subjects
timeFrame: 24 weeks
Secondary outcomes:
measure: 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
timeFrame: 24 weeks
measure: To examine the pharmacokinetics of AC2307 injected SC BID in obese or overweight subjects
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Chandler
country: United States
facility: Research Site
state: Arizona
city: Santa Rosa
country: United States
facility: Research Site
state: California
city: Walnut Creek
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Overland Park
country: United States
facility: Research Site
state: Kansas
city: Baton Rouge
country: United States
facility: Research Site
state: Louisiana
city: Butte
country: United States
facility: Research Site
state: Montana
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Eugene
country: United States
facility: Research Site
state: Oregon
city: Medford
country: United States
facility: Research Site
state: Oregon
city: Greer
country: United States
facility: Research Site
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Research Site
state: South Carolina
city: Austin
country: United States
facility: Research Site
state: Texas
city: Olympia
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: Amylin Pharmaceuticals, LLC.
name: Hubert Chen, MD
role: STUDY_DIRECTOR
References: