Atherosclerosis vaccine, V6, has been through two small-scale Phase II open label clinical trials. It has shown significant improvement in lipid profile in patients with overweight or obesity
The proposed study will evaluate daily dose of one V6 pill administered for one month in placebo-controlled, randomized, double-blind phase 3 trial in men and women with baseline waist diameter over 90 and 80 cm respectively. The effect of V6 will be assessed by changes in lipid profile, i.e., LDL, HDL, TG and TC; anthropomorphic indices, i.e., circumference of waist, mid-arm, and hips; arterial blood pressure and fasting glucose levels at baseline versus post-treatment timepoint.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
300
Atherosclerosis vaccine, V6, formulated as an oral pill made from from pooled antigens derived from adipose tissue
Half of the patients will be randomly assigned to receive placebo pill
Immunitor LLC
Ulaanbaatar, CA, Mongolia
RECRUITINGImmunotherapy of atherosclerosis
Effect on lipid profile as measured by changes in LDL, HDL, triglycerides and total cholesterol
Time frame: 1 month
Effect on anthropomorphic indices of obesity
Effect on diameter of waist, mid-arm and hip after one month of treatment versus baseline measurements
Time frame: 1 month
Effect on hypertension
The systolic and diastolic blood pressures measured one month apart
Time frame: 1 month
Effect on glucose levels
Changes in fasting glucose levels from baseline to post-treatment time-point
Time frame: 1 month
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