Combined HyperlipidemiaPhase 2/3NCT05742022
"Phospholipovit" vs Placebo in Patients With Combined Hyperlipidemia
A Phase 2/3 study testing "Phospholipovit" in people with Combined Hyperlipidemia, run by Institute of Biomedical Chemistry, Russia at 3 sites in Russia.
Trial summary
"Phospholipovit" vs placebo in patients with combined hyperlipidemia Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Combined Hyperlipidemia
- What is being tested?
- "Phospholipovit"
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesRussia
- Study dates
- 1 Jan 2016to 20 Dec 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
Federal State Budgetary Institution "National Medical Research Centre Of Cardiology" of the Ministry of Health of the Russian Federation
Moscow, 121552
LLC "Nizhny Novgorod Medical clinic"
Nizhny Novgorod, 603071
LLC "Medical Center for Diagnostics and prevention plus"
Yaroslavl, 150040
About this study
Official title: 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
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.
- Conditions
- Combined Hyperlipidemia
- Being tested
- "Phospholipovit", Placebo
- Keywords
- Phospholipid nanoparticles, non-HDL-C level, TG level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Phospholipovit"Drug
500 mg orally 2 times a day, for 12 weeks
PlaceboDrug
500 mg orally 2 times a day, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| "Phospholipovit" | Experimental | Powder for preparing a solution for oral administration. 500 mg orally 2 times a day, for 12 weeks Receives: Drug: "Phospholipovit" |
| Placebo | Experimental | Powder for preparing a solution for oral administration. 500 mg orally 2 times a day, for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: week 12
Secondary outcomes (11)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start1 Jan 2016
- Primary completion20 Jun 2018
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Combined HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Biomedical Chemistry, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander I. Archakov, MD, PhD, Principal investigator, Institute of Biomedical Chemistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742022
- Sponsor's protocol ID
- 05F
- Status last verified
- Feb 2023
- First submitted
- 1 Feb 2023
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter, Placebo-controlled Clinical Trial of Safety and Efficacy of "Phospholipovit" in Patients With Combined Hyperlipidemia
- ClinicalTrials.gov ID
- NCT05742022
- Acronym / sponsor ID
- 05F
- Conditions
- Combined Hyperlipidemia
- Keywords
- Phospholipid nanoparticles, non-HDL-C level, TG level
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institute of Biomedical Chemistry, RussiaUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 20 Jun 2018 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"Phospholipovit" vs placebo in patients with combined hyperlipidemia
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| "Phospholipovit" | Experimental | Drug: "Phospholipovit"Powder for preparing a solution for oral administration. 500 mg orally 2 times a day, for 12 weeks |
| Placebo | Experimental | Drug: PlaceboPowder for preparing a solution for oral administration. 500 mg orally 2 times a day, for 12 weeks |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (27 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Phospholipovit"500 mg orally 2 times a day, for 12 weeks | Drug | "Phospholipovit" |
| Placebo500 mg orally 2 times a day, for 12 weeks | Drug | Placebo |
Primary outcome
Percentage change from baseline in non-HDL-C values
Time frame: week 12
The efficacy is evaluated in terms of the percentage change from baseline in non-HDL-C values
11 secondary outcomes
Dynamics of change of total cholesterol level compared with the baseline
Time frame: week 12
Dynamics of change of LDL-C level compared with the baseline
Time frame: week 12
Dynamics of change of HDL-C level compared with the baseline
Time frame: week 12
Dynamics of change of TG level compared with the baseline
Time frame: week 12
Dynamics of change of VLDL-C level compared with the baseline
Time frame: week 12
Dynamics of change of Apo-A1 level compared with the baseline
Time frame: week 12
Dynamics of change of Apo-B level compared with the baseline
Time frame: week 12
Dynamics of change of LP (a) level compared with the baseline
Time frame: week 12
Dynamics of change of atherogenic index compared with the baseline
Time frame: week 12
Dynamics of average hs-CRP level compared with the baseline
Time frame: week 12
Change in composition and particle size of fasting HDL-C, LDL-C and VLDL-C compared with the baseline
Time frame: week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Combined Hyperlipidemia
RecruitingObservational study
A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe
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RecruitingPhase 3
A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Rosuvastatin on LDL-C in Patients With Hypercholesterolaemia
Hypercholesterolaemia
Active, not recruitingObservational study
Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia
Hypercholesterolemia, Mixed Dyslipidemia
RecruitingPhase 3
A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin and Placebo on LDL-C in LLT-naïve Patients.
Hypercholesterolaemia
Active, not recruitingPhase 3
A Study to Evaluate the Effect of Obicetrapib/Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and/or Metabolic Syndrome
Lipidemia, Type 2 Diabetes (T2DM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander I. Archakov, MD, PhD principal investigator
Institute of Biomedical Chemistry
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing "Phospholipovit" in people with Combined Hyperlipidemia, run by Institute of Biomedical Chemistry, Russia at 3 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change from baseline in non-HDL-C values (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.