Overview

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

Status:
Completed

Trial end date:
2009-09-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

AstraZeneca

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