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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Overweight; Obesity

Treatments: Drug: placebo; Drug: AC2307

Study type: Interventional

Funder types: Industry

Identifiers

NCT00785408

CFA104

Details and patient eligibility

About

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.

Enrollment: 273 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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273 participants in 6 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: AC2307

Drug: AC2307

Drug: AC2307

2

Experimental group

Treatment:

Drug: AC2307

Drug: AC2307

Drug: AC2307

3

Experimental group

Treatment:

Drug: AC2307

Drug: AC2307

Drug: AC2307

4

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo

5

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo

6

Placebo Comparator group

Treatment:

Drug: placebo

Drug: placebo

Drug: placebo