NCT03042741

Vaccine Against Atherosclerosis in Patients With Overweight Problems or Obesity

Phase II Trial of Daily Dose of Oral Vaccine Against Atherosclerosis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Immunitor LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Atherosclerosis

Interventions

Type	Name	Description
BIOLOGICAL	atherosclerosis vaccine	Atherosclerosis vaccine, V6, formulated as an oral pill made from from pooled antigens derived from adipose tissue
BIOLOGICAL	Placebo pills	Half of the patients will be randomly assigned to receive placebo pill

Timeline

• Start date: 2017-02-01
• Primary completion: 2019-12-18
• Completion: 2019-12-18
• First posted: 2017-02-03
• Last updated: 2019-04-16

Locations

1 site across 1 country: Mongolia