Status:
COMPLETED
Safety Study of the Inhibition of Agouti-related Protein (AgRP) for the Management of Obesity and Weight Loss
Lead Sponsor:
vTv Therapeutics
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Multiple pathways including peripheral and central hormones and neurotransmitters are involved in the regulation of food intake and body weight. One of the most studied pathways involves the melanocor...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00779519
Start Date
February 1 2009
Last Update
June 27 2011
Active Locations (12)
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1
Los Angeles, California, United States, 90095
2
San Diego, California, United States, 92130
3
Augusta, Georgia, United States, 30909
4
Springfield, Illinois, United States, 26704