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CompletedNCT05742022Updated Feb 23, 2023

"Phospholipovit" vs Placebo in Patients With Combined Hyperlipidemia

A Phase 2/3 interventional study of "Phospholipovit" and Placebo in Combined Hyperlipidemia, sponsored by Institute of Biomedical Chemistry, Russia. Completed at 3 sites in Russian Federation. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-02-23.

Sponsored by Institute of Biomedical Chemistry, Russia · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Registered 7 years 1 month after the study started (first participant enrolled Jan 2016, registered Feb 2023).
Phase
Phase 2/3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
30 Years to 75 Years
Sex
All
01

Study summary

"Phospholipovit" vs placebo in patients with combined hyperlipidemia

Read the 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.

02

Conditions studied

  • Combined Hyperlipidemia

Keywords

  • Phospholipid nanoparticles
  • non-HDL-C level
  • TG level
03

In context

Hyperlipidemia, Familial Combined

32 studies on the registry are indexed under Hyperlipidemia, Familial Combined; 1 is open to participants now.

This study's enrollment of 100 is below the median of 334 across 25 interventional studies indexed under Hyperlipidemia, Familial Combined.

Browse Hyperlipidemia, Familial Combined studies →

Lead sponsor

Institute of Biomedical Chemistry, Russia is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    "Phospholipovit"

    Powder for preparing a solution for oral administration. 500 mg orally 2 times a day, for 12 weeks

    Drug: "Phospholipovit"

  • Experimental
    Placebo

    Powder for preparing a solution for oral administration. 500 mg orally 2 times a day, for 12 weeks

    Drug: Placebo

Interventions

  • Drug"Phospholipovit"

    500 mg orally 2 times a day, for 12 weeks

  • DrugPlacebo

    500 mg orally 2 times a day, for 12 weeks

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: week 12

Secondary outcomes

  1. 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

    Time frame: week 12

  2. 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

    Time frame: week 12

  3. 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

    Time frame: week 12

  4. 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

    Time frame: week 12

  5. 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

    Time frame: week 12

  6. 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

    Time frame: week 12

  7. 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

    Time frame: week 12

  8. 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

    Time frame: week 12

  9. 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

    Time frame: week 12

  10. 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

    Time frame: week 12

  11. 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)

    Time frame: week 12

Other outcomes

  1. 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

    Time frame: within 12 weeks

  2. 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

    Time frame: within 12 weeks

07

Study locations

3 sites
  • Federal State Budgetary Institution "National Medical Research Centre Of Cardiology" of the Ministry of Health of the Russian Federation
    Moscow, 121552, Russian Federation
  • LLC "Nizhny Novgorod Medical clinic"
    Nizhny Novgorod, 603071, Russian Federation
  • LLC "Medical Center for Diagnostics and prevention plus"
    Yaroslavl, 150040, Russian Federation
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05742022
Lead sponsor
Institute of Biomedical Chemistry, Russia
Responsible party
Sponsor
First posted
Feb 23, 2023
Start date
Jan 1, 2016
Primary completion
Jun 20, 2018
Completion
Dec 20, 2022
Last update
Feb 23, 2023

Study contacts

Alexander I. Archakov, MD, PhD
principal investigator · Institute of Biomedical Chemistry

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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