Vaccine Against Atherosclerosis in Patients With Overweight Problems or Obesity (V6)

Immunitor

Status and phase: Unknown; Phase 3

Conditions: Atherosclerosis

Treatments: Biological: atherosclerosis vaccine; Biological: Placebo pills

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03042741

V6

Details and patient eligibility

About

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

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Baseline waist diameter over 90 and 80 cm for men and women, respectively

Exclusion criteria

• Pregnant and lactating women
• Individuals with clinical symptoms or diseases who in opinion of study investigators are not eligible to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 participants in 2 patient groups, including a placebo group

V6 recipients

Experimental group

Description:

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

Treatment:

Biological: atherosclerosis vaccine

Placebo recipients

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo pills