A Phase 3 interventional study of atherosclerosis vaccine and Placebo pills in Atherosclerosis, sponsored by Immunitor LLC. Status unknown at 1 site in Mongolia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by Immunitor LLC · Phase 3, Interventional, and Treatment
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.
1,517 studies on the registry are indexed under Atherosclerosis; 224 are open to participants now.
This study's planned enrollment of 300 is above the median of 100 across 879 interventional studies indexed under Atherosclerosis.
Browse Atherosclerosis studies →Immunitor LLC is the lead sponsor of 14 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Arm will comprise 150 individuals with overweight problem or obesity randomly assigned to receive V6 - oral atherosclerosis vaccine administered once per day for one month
Biological: atherosclerosis vaccine
Arm will comprise 150 individuals with overweight problem or obesity randomly assigned to receive placebo pills given once per day as a single pill for one month
Biological: Placebo pills
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
Immunotherapy 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
Plan to share: Undecided — Data will be shared without identification of participants
This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Immunitor LLC