Safety Study of the Inhibition of Agouti-related Protein (AgRP) for the Management of Obesity and Weight Loss
NCT ID: NCT00779519
Last Updated: 2011-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2009-02-28
Brief Summary
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It is reasonable to speculate that if there is an imbalance of alphaMSH and AgRP exist in obese individuals and inhibiting the activity of AgRP may be of therapeutic benefit in treating obesity.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo
TTP435
TTP435
Interventions
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TTP435
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
Yes
Sponsors
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vTv Therapeutics
INDUSTRY
Responsible Party
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TransTech Pharma
Principal Investigators
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James Wamsley, MD
Role: STUDY_CHAIR
vTv Therapeutics
Locations
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Los Angeles, California, United States
San Diego, California, United States
Augusta, Georgia, United States
Springfield, Illinois, United States
Reno, Nevada, United States
New York, New York, United States
Charlotte, North Carolina, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Halifax, Nova Scotia, Canada
Oakville, Ontario, Canada
Toronto, Ontario, Canada
Countries
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Other Identifiers
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TTP435-201
Identifier Type: -
Identifier Source: org_study_id
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