Phospholipovit vs Placebo in Patients With Combined Hyperlipidemia

Study Overview
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Brief Summary
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Phospholipovit vs placebo in patients with combined hyperlipidemia

Detailed Description
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It is well known that atherosclerosis and its complications are the leading cause of morbidity and mortality in the world, and the high blood cholesterol is one of the leading risk factors for atherosclerosis. Among cholesterol-lowering agents, the most common are inhibitors of HMG-CoA reductase, so-called statins. Nevertheless, low attention is paid to the process responsible for cholesterol removing from the cells - the so-called reverse cholesterol transport (RCT). The major lipoproteins, involved in RCT, are high-density lipoproteins (HDL). The effectiveness of RCT is determined not only by the level of cholesterol in HDL, but also by the composition of HDL, in particular, by the content of phosphatidylcholine (PC) in HDL. Based on the original phospholipid composition, the Institute of Biomedical Chemistry developed the Phospholipovit - the aqueous medium of nanoemulsion of phospholipids with a particle size of 20-25 nm. The intestinal absorption of phospholipids nanoemulsion should contribute to the HDL enrichment by phospholipids, and, consequently, to the enhancement of RCT. A study of the safety and tolerability of the Phospholipovit in healthy patients has been completed. The Phospholipovit has demonstrated safety and tolerability. The main objective of this study is to evaluate the effectiveness and safety of Phospholipovit, a powder for preparation of an oral solution, 500 mg compared with placebo in patients with combined hyperlipidemia.

Official Title
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A Randomized, Double-blind, Multicenter, Placebo-controlled Clinical Trial of Safety and Efficacy of Phospholipovit in Patients With Combined Hyperlipidemia

Conditions
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Combined Hyperlipidemia

Intervention / Treatment
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* Drug: Phospholipovit
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Availability of signed and dated informed consent of the patient to participate in the study; Patients with moderate combined hyperlipidemia, defined as: Total cholesterol level 3 - 7 mmol/l, LDL-C 2.5 - 5 mmol/l, TG 1.7 - 4.5 mmol/l, and HDL-C < 1 mmol/l during screening for men and < 1.2 mmol/l for women; Patient consent to use reliable contraceptive methods throughout the study; The patient's ability to adequately cooperation. Exclusion Criteria: TG > 4.5 mmol/l; Total cholesterol >7 mmol/l; LDL cholesterol >5 mmol/l; Age less than 30 or older than 75; Diseases or metabolic disorders that can cause an increase in LDL-C, total cholesterol and TG (secondary dyslipidemia); Patients receiving high doses of statin drugs (rosuvastatin ≥40 mg, atorvastatin ≥80 mg); Any acute or exacerbation of chronic infectious diseases; Type 1 Diabetes mellitus; Glomerular filtration rate less than 30 ml/min/1.73 m2; Patients who have undergone acute conditions (infections, injuries, operations) in the period less than 2 months before the start of the study; Patients with severe dysfunction of the liver and/or kidneys, and/or other vital organs, accompanied by decompensation of their functions; diseases of the central nervous system, with severe impairment of cognitive and mnestic functions; Persistent increase in liver enzymes activity (transaminases) of unclear etiology or increased liver enzymes activity by 2 or more times from the upper limit of the norm; Alcohol abuse more than 5 units of alcohol per week (1 unit alcohol is equivalent to 0.325 liters beer, 130 ml wine, 30 ml alcohol); Drug use; A history of a positive HIV test result; Positive test result for hepatitis B and C, syphilis; A history of hypothyroidism or thyroid-stimulating hormone levels (TSH) exceeding > 1X upper limit of normal (ULN) during screening; History of oncological disease during the last 5 years; Patients diagnosed with porphyria; Patients diagnosed with myopathy; Clinically significant abnormal blood test results general urinalysis at screening; Hypersensitivity to phospholipids or any components of investigational drug; Indications for drug therapy a list of therapies prohibited during the study; Any other diseases or conditions that, in the opinion of the investigator, may distort the results of the study and limit the patient's participation in the study; Pregnancy and lactation; Patient participation in another clinical trial or use of any investigational drug during 1 month prior to inclusion in the study; Not using contraception for patients of reproductive age.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: At clinical centers, patients will be equally randomized by the envelope method into two groups to receive Phospholipovit or placebo. The drugs will be administered after the signed informed consent. Phospholipovit will be administered 500 mg orally 2 times a day, for 12 weeks. Placebo will be administered orally 2 times a day, for 12 weeks. All patients will be examined after 12 weeks.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phospholipovit<br>Powder for preparing a solution for oral administration. 500 mg orally 2 times a day, for 12 weeks | Drug: Phospholipovit<br>* 500 mg orally 2 times a day, for 12 weeks<br>|
| Experimental: Placebo<br>Powder for preparing a solution for oral administration. 500 mg orally 2 times a day, for 12 weeks | Drug: Placebo<br>* 500 mg orally 2 times a day, for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change from baseline in non-HDL-C values | The efficacy is evaluated in terms of the percentage change from baseline in non-HDL-C values | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamics of change of total cholesterol level compared with the baseline | The efficacy is evaluated in terms of the dynamics of change of total cholesterol level compared with the baseline | week 12 | 
| Dynamics of change of LDL-C level compared with the baseline | The efficacy is evaluated in terms of the dynamics of change of LDL-C level compared with the baseline | week 12 | 
| Dynamics of change of HDL-C level compared with the baseline | The efficacy is evaluated in terms of the dynamics of change of HDL-C level compared with the baseline | week 12 | 
| Dynamics of change of TG level compared with the baseline | The efficacy is evaluated in terms of the dynamics of change of TG level compared with the baseline | week 12 | 
| Dynamics of change of VLDL-C level compared with the baseline | The efficacy is evaluated in terms of the dynamics of change of VLDL-C level compared with the baseline | week 12 | 
| Dynamics of change of Apo-A1 level compared with the baseline | The efficacy is evaluated in terms of the dynamics of change of Apo-A1 level compared with the baseline | week 12 | 
| Dynamics of change of Apo-B level compared with the baseline | The efficacy is evaluated in terms of the dynamics of change of Apo-B level compared with the baseline | week 12 | 
| Dynamics of change of LP (a) level compared with the baseline | The efficacy is evaluated in terms of the dynamics of change of LP (a) level compared with the baseline | week 12 | 
| Dynamics of change of atherogenic index compared with the baseline | The efficacy is evaluated in terms of the dynamics of change of atherogenic index compared with the baseline | week 12 | 
| Dynamics of average hs-CRP level compared with the baseline | The efficacy is evaluated in terms of the dynamics of average hs-CRP level compared with the baseline | week 12 | 
| Change in composition and particle size of fasting HDL-C, LDL-C and VLDL-C compared with the baseline | The efficacy is evaluated in terms of the change in composition and particle size of fasting HDL-C, LDL-C and VLDL-C compared with the baseline (limited sample of patients) | week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phospholipid nanoparticles, non-HDL-C level, TG level