Safety Study of the Inhibition of Agouti-related Protein (AgRP) for the Management of Obesity and Weight Loss

Inclusion criteria

• Male or female volunteers, aged 18 to 65 years, inclusive.
• Subjects must be obese (class 1: BMI of 30.0 to 34.9 kg/m2 or class 2: BMI of 35 to 39.9 kg/m2 in non-Asians and BMI of 27.0 - 31.9 kg/m2 or 32.0 - 36.9 kg/m2 in Asians) at the Screening Visit.
• Female subjects must be postmenopausal (with amenorrhea for at least 2 years prior to scheduled dosing and confirmatory FSH test in the range of 23-116 IU/L) or surgically sterile (with physician or insurance documentation of bilateral tubal ligation at least 6 months prior to Screening Visit or of a hysterectomy and/or bilateral oophorectomy) and agree not to undergo in vitro fertilization during the study and for 6 months post treatment.

Exclusion criteria

• Type 1 diabetes.
• Type 2 diabetes.
• History of myocardial infarction, stroke, including transient ischemic attack, in the last 2 years.
• Asthma or chronic obstructive pulmonary disease controlled by regular use of inhaled steroids.
• Subjects with rheumatoid arthritis, lupus, or multiple sclerosis regularly requiring steroids or disease-modifying anti-rheumatic agents.
• Subjects with psoriasis requiring oral steroids.
• Subjects planning to undergo gastric bypass or resection surgery, or who have had such a procedure in the 6 months prior to the Screening Visit.