Atherosclerosis
Conditions
Brief summary
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
Detailed 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.
Interventions
BIOLOGICALatherosclerosis vaccine
Atherosclerosis vaccine, V6, formulated as an oral pill made from from pooled antigens derived from adipose tissue
BIOLOGICALPlacebo pills
Half of the patients will be randomly assigned to receive placebo pill
Sponsors
Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
Immunitor LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double-blind study in two groups of patients assigned randomly into experimental and placebo arms
Intervention model description
Group on experimental drug compared against group receiving placebo in randomized, blinded phase III study to evaluate effect on lipid profile, i.e., LDL, HDL, triglycerides and total cholesterol
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunotherapy of atherosclerosis | 1 month | Effect on lipid profile as measured by changes in LDL, HDL, triglycerides and total cholesterol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect on anthropomorphic indices of obesity | 1 month | Effect on diameter of waist, mid-arm and hip after one month of treatment versus baseline measurements |
| Effect on hypertension | 1 month | The systolic and diastolic blood pressures measured one month apart |
| Effect on glucose levels | 1 month | Changes in fasting glucose levels from baseline to post-treatment time-point |
Countries
Mongolia
Contacts
Primary Contactaldar bourinbayar, PhD, MD/PhD
Backup Contactgalyna kutsyna, MD, MD/PhD
Outcome results
None listed