"Phospholipovit" vs Placebo in Patients With Combined Hyperlipidemia

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

"Phospholipovit" vs placebo in patients with combined hyperlipidemia

Study Overview

• Status: Completed
• Conditions: Combined Hyperlipidemia
• Intervention / Treatment: Drug: "Phospholipovit"; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 121552
    • Federal State Budgetary Institution "National Medical Research Centre Of Cardiology" of the Ministry of Health of the Russian Federation
  • Nizhny Novgorod, Russian Federation, 603071
    • LLC "Nizhny Novgorod Medical clinic"
  • Yaroslavl, Russian Federation, 150040
    • LLC "Medical center for diagnostics and prevention plus"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "Phospholipovit"; Powder for preparing a solution for oral administration. 500 mg orally 2 times a day, for 12 weeks	Drug: "Phospholipovit"; 500 mg orally 2 times a day, for 12 weeks
Experimental: Placebo; Powder for preparing a solution for oral administration. 500 mg orally 2 times a day, for 12 weeks	Drug: Placebo; 500 mg orally 2 times a day, for 12 weeks

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety endpoint - Number and severity of serious adverse events (SAEs) and AEs in organs and systems	The safety is evaluated in terms of the number and severity of SAEs and AEs in organs and systems	within 12 weeks
Safety endpoint - The frequency of cases of early termination of participation in the study due to the development AE and SAE	The safety is evaluated in terms of the frequency of cases of early termination of participation in the study due to the development AE and SAE	within 12 weeks

Collaborators and Investigators

• Sponsor: Institute of Biomedical Chemistry, Russia
• Investigators: Principal Investigator: Alexander I. Archakov, MD, PhD, Institute of Biomedical Chemistry

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): June 20, 2018
• Study Completion (Actual): December 20, 2022

Study Registration Dates

• First Submitted: February 1, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Estimate): February 23, 2023

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Phospholipid nanoparticles; non-HDL-C level; TG level
• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Dyslipidemias; Lipid Metabolism, Inborn Errors; Hyperlipidemias; Hyperlipoproteinemias; Hyperlipidemia, Familial Combined
• Other Study ID Numbers: 05F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No