DyslipidemiaPhase 2NCT07908433
Study of the Safety and Efficacy of Prenofitol Tablets
A Phase 2 study testing 1 tablet of Prenofitol and 2 tablets of Prenofitol in people with Dyslipidemia, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation.
Trial summary
Stage 1 of the Study Stage 1 of the study will consist of: a screening period (Visit 0) conducted within 0-14 days prior to the start of treatment; an inpatient treatment period, including Visit 1 (Days 1-4) and Visit 2 (Days 7-8), during which blood samples will be collected for pharmacokinetic (PK) analysis and… Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- 1 tablet of Prenofitol and 2 tablets of Prenofitol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2026to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stage 1.
- Patients meeting all of the following criteria will be eligible for inclusion in the study:
- Volunteers of either sex, aged 40 to 69 years (inclusive);
- Provision of signed Informed Consent prior to the initiation of any screening procedures, and, in the Investigator's opinion, the ability to comply with all study requirements;
- Body mass index (BMI) of 18.5-39.9 kg/m² (inclusive);
- Low-density lipoprotein cholesterol (LDL-C) level >3 mmol/L and <6.5 mmol/L at the time of screening;
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- Triglyceride (TG) level <4.5 mmol/L at the time of screening.
- Agreement by all volunteers and the female sexual partners of male volunteers of reproductive potential to use barrier methods of contraception throughout the study and for one month after completion of the study;
- Negative pregnancy test based on a urine test performed at the screening visit (for all female study participants);
- Negative test results for HIV, hepatitis B and hepatitis C, and syphilis;
- Negative urine test for narcotic drugs and psychostimulant substances;
- Negative alcohol test;
- Ability to attend all study visits. Stage 2
- Patients meeting all of the following criteria will be eligible for inclusion in the study:
- Provision of signed Informed Consent prior to the initiation of any screening procedures, and, in the Investigator's opinion, the ability to comply with all study requirements;
- Male and female patients aged 40 to 69 years (inclusive);
- Low-density lipoprotein cholesterol (LDL-C) level >3 mmol/L and <6.5 mmol/L at the time of screening;
- Triglyceride (TG) level <4.5 mmol/L at the time of screening;
- Essential arterial hypertension;
- Medically controlled endocrine disorders;
- Medically controlled diabetes mellitus, with a glycated hemoglobin (HbA1c) level of <6.5%;
- Body mass index (BMI) of 18.5-39.9 kg/m² (inclusive);
- Agreement by all patients and the female sexual partners of male patients of reproductive potential to use barrier methods of contraception throughout the study and for one month after completion of the study.
- Negative pregnancy test based on a urine test performed at the screening visit (for women of reproductive potential);
- Negative blood test results for HIV, hepatitis B and hepatitis C, and syphilis;
- Negative urine test for narcotic drugs and psychostimulant substances;
- No smoking of tobacco products or use of nicotine-containing products for 6 months prior to screening;
- Negative cotinine test;
- Negative alcohol test;
- Ability to attend all study visits.
Who cannot join
- Stage 1.
- Inability to read in Russian; inability or unwillingness to understand the nature of the study. Any other conditions that limit the validity of obtaining informed consent or may affect the patient's ability to participate in the study;
- Significant history of allergic reactions or drug intolerance;
- Acute coronary syndrome or stroke occurring less than 1 year prior to enrollment in the study;
- Use of medicinal products that have a pronounced effect on hemodynamics, liver function, or other relevant functions (e.g., barbiturates, omeprazole, cimetidine, rifampicin, etc.) within 2 months prior to the start of the study;
- Use of medicinal products (prescription or over-the-counter), including herbal medicinal products (e.g., St. John's wort), cytochrome CYP3A enzyme inducers, vitamins, and biologically active food supplements within 14 days prior to the start of the study;
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- Depot injections of any medicinal products within 3 months prior to the start of the study and throughout the entire study period until the patient has completed their participation in the study;
- Consumption of more than 10 units of alcohol per week (1 unit of alcohol is equivalent to 0.5 L of beer, 200 mL of dry wine, or 50 mL of spirits) or a history of alcoholism;
- Blood donation of 450 mL or more of blood or plasma within 2 months prior to the study;
- Clinically significant, in the Investigator's opinion, abnormalities in complete blood count, blood biochemistry, or other laboratory parameters relevant to the safety of participation in the study;
- Positive test results for HIV, syphilis, or hepatitis B or C markers (HBsAg and anti-HCV);
- Participation in a clinical trial involving medicinal products within 3 months prior to the start of the study;
- A history of surgical procedures involving the gastrointestinal tract, except appendectomy;
- Chronic or acute diseases of the cardiovascular, bronchopulmonary, nervous, or endocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys, or blood; psychiatric disorders, including a history of psychiatric disorders;
- Acute infectious diseases (influenza, acute respiratory viral infections, etc.) within 4 weeks prior to the start of the study;
- Dehydration due to diarrhea, vomiting, or any other cause within 24 hours prior to the start of the study;
- A history of drug and/or medicinal product dependence and/or substance abuse;
- Positive breath alcohol test or positive urine test for narcotic drugs and/or potent medicinal substances;
- Positive pregnancy test;
- Inability to place a venous catheter for blood sampling (e.g., due to skin disorders at venipuncture sites);
- Mental, physical, or other conditions that prevent the patient from adequately assessing their own behavior and/or properly complying with the requirements of the study protocol;
- A special diet (e.g., vegetarian, vegan, or sodium-restricted diet) or lifestyle (e.g., night-shift work or extreme physical exertion).
- Stage 2.
- Patients will not be eligible for inclusion in the study if they meet at least one of the following criteria:
- Inability to read in Russian; inability or unwillingness to understand the nature of the study. Any other conditions that limit the validity of obtaining informed consent or may affect the patient's ability to participate in the study;
- Significant history of allergic reactions or drug intolerance;
- Hypersensitivity to any component of the investigational medicinal products;
- A history of familial hypercholesterolemia or type I, III, IV, or V hyperlipoproteinemia;
- Grade III obesity or higher (BMI >40 kg/m²);
- Use of any statins or regular use of other lipid-lowering medicinal products within 3 months prior to screening;
- Clinically significant cardiovascular diseases (myocardial infarction, stroke, coronary artery bypass grafting, or percutaneous coronary angioplasty); symptoms of severe congestive heart failure (CHF), functional class (FC) II-IV according to NYHA (or heart failure with preserved ejection fraction [HFpEF] or heart failure with reduced ejection fraction [HFrEF]);
- Active liver disease at screening; serum transaminase levels more than 3 times the upper limit of normal (ULN) at screening; Child-Pugh class B or C liver cirrhosis; myopathy; serum creatine phosphokinase (CPK) levels more than 4 times the ULN at screening; serum creatinine <70 μmol/L;
- Active neoplastic process, carcinoid syndrome, malignancy within 5 years prior to the start of the study, or immunodeficiency disorders;
- Prior therapy with glucocorticosteroid hormones, systemic antineoplastic agents, or immunosuppressive medicinal products within 6 months prior to screening;
- Participation in another clinical trial involving a medicinal product concurrently with or within 90 days prior to enrollment in this study;
- For women of reproductive potential: pregnancy and/or breastfeeding, or refusal to use a reliable method of contraception;
- Severe, decompensated, or unstable somatic diseases, or any other diseases or conditions that, in the Investigator's opinion, may complicate the interpretation of treatment results;
- Any hemodynamic type of congestive heart failure (CHF);
- Requirement for the use of medicinal products prohibited by the study protocol;
- Unwillingness to participate in the clinical study, or inability or unwillingness of the patient to comply with the treatment protocol requirements, including adherence to the visit schedule and treatment compliance, and to follow the rules of participation in the clinical study.
About this study
Official title: Double-blind, Placebo-controlled, Randomized, Comparative, Prospective Clinical Study of the Efficacy and Safety of Prenofitol Tablets at Different Doses, With an Open-label Pharmacokinetic Study Phase in Patients With Dyslipidemia.
Stage 1 of the Study
Stage 1 of the study will consist of:
Read more
a screening period (Visit 0) conducted within 0-14 days prior to the start of treatment; an inpatient treatment period, including Visit 1 (Days 1-4) and Visit 2 (Days 7-8), during which blood samples will be collected for pharmacokinetic (PK) analysis and safety parameters will be assessed.
Upon completion of the inpatient treatment period, the study data will be submitted to the National Center for Medicines and Medical Devices (NCMD) for analysis and assessment of tolerability and safety parameters. Based on the NCMD conclusion, a decision will be made regarding the feasibility of proceeding to Stage 2 of the study.
an outpatient treatment period lasting for the subsequent 83 days (11 weeks), during which safety parameters will be assessed at the following time points: Day 28 (Visit 4), Day 56 (Visit 5), and Day 90 (Visit 7) from the start of treatment. Adverse events (AEs) and serious adverse events (SAEs) will be recorded at the above-mentioned visits and during telephone follow-up contacts at Day 14 (Visit 3) and Day 84 (Visit 6); a follow-up period lasting for the subsequent 90 days (up to Week 24 from the start of treatment). Safety parameters will be assessed by telephone follow-up at Day 120 (Visit 8), Day 150 (Visit 9), and at the final Visit on Day 180 (Visit 10).
The treatment duration will be 90 days, and the follow-up period will be 90 days. The total study duration for each patient will be 180 days (approximately 6 months).
Stage 2 of the Study
Stage 2 of the study will consist of:
a screening period (Visit 0) conducted within 0-14 days prior to the start of treatment; an outpatient treatment period lasting for the subsequent 90 days (12 weeks), during which safety and efficacy parameters and immune status will be assessed at the following time points: Day 1 (Visit 1), Day 7 (Visit 3), Day 28 (Visit 6), and Day 90 (Visit 8). Additional blood samples for immune status assessment will be collected on Day 2 (Visit 2), Day 14 (Visit 4), and Day 21 (Visit 5) from the start of treatment.
AEs and SAEs will be recorded at the above-mentioned visits and during a telephone follow-up contact on Day 56 (Visit 7).
Upon completion of the 90-day treatment period (Visit 8), the study data will be submitted to the National Center for Medicines and Medical Devices (NCMD) for assessment of safety and efficacy parameters.
a follow-up period lasting for the subsequent 90 days (up to Week 24 from the start of treatment), during which safety and efficacy parameters and immune status will be assessed at Day 120 (Visit 9), Day 150 (Visit 10), and at the final Visit on Day 180 (Visit 11).
The treatment duration will be 90 days, and the follow-up period after completion of treatment will be 90 days. The total study duration for each patient will be 180 days (approximately 6 months).
- Conditions
- Dyslipidemia
- Being tested
- 1 tablet of Prenofitol, 2 tablets of Prenofitol, 1 tablet of placebo, 2 tablets of placebo
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 tablet of PrenofitolDrug
Participants will receive Prenofitol tablets. 1 tablet, 2 times a day with 12-hour intervals.
2 tablets of PrenofitolDrug
Participants will receive Prenofitol tablets. 2 tablets, 2 times a day with 12-hour intervals.
1 tablet of placeboDrug
Participants will receive placebo tablets. 1 tablet, 2 times a day with 12-hour intervals.
2 tablets of placeboDrug
Participants will receive placebo tablets. 2 tablets, 2 times a day with 12-hour intervals.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1. Open-label. Assessment of pharmacokinetics. (Group 1) | Experimental | 1 tablet of study drug 2 times a day with 12-hour intervals Receives: Drug: 1 tablet of Prenofitol |
| Stage 1. Open-label. Assessment of pharmacokinetics. (Group 2) | Experimental | 2 tablets of study drug 2 times a day with 12-hour intervals Receives: Drug: 2 tablets of Prenofitol |
| Stage 2. Double-blind, placebo-controlled, randomized, comparative. (Group 3) | Experimental | 1 tablet of study drug + 1 tablet of placebo, 2 times a day with 12-hour intervals Receives: Drug: 1 tablet of Prenofitol; Drug: 1 tablet of placebo |
| Stage 2. Double-blind, placebo-controlled, randomized, comparative. (Group 4) | Experimental | 2 tablets of study drug 2 times a day with 12-hour intervals Receives: Drug: 2 tablets of Prenofitol |
| Stage 2. Double-blind, placebo-controlled, randomized, comparative. (Group 5) | Placebo comparator | 2 tablets of placebo 2 times a day with 12-hour intervals Receives: Drug: 2 tablets of placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients achieving the target LDL-C level of <3.0 mmol/L compared with the baseline value in the investigational treatment groups and the placebo group at 90 days from the start of treatment (Visit 8).
Measured: 180 days from the start of treatment
Secondary outcomes (4)
The proportion of patients achieving a ≥50% reduction in LDL-C from the baseline value in the investigational treatment groups and the placebo group at 90 days from the start of treatment (Visit 8)
Measured: 180 days from the start of treatment
The proportion of patients achieving a ≥25% reduction in LDL-C from the baseline value in the investigational treatment groups and the placebo group at 90 days from the start of treatment (Visit 8)
Measured: 180 days from the start of treatment
The proportion of patients achieving an LDL-C level of <3.0 mmol/L compared with the baseline value in the investigational treatment groups and the placebo group
Measured: 180 days from the start of treatment
The change in lipid metabolism parameters, including triglyceride levels, in the investigational treatment groups and the placebo group
Measured: 180 days from the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start2 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908433
- Sponsor's protocol ID
- 02-PREN-2025
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-controlled, Randomized, Comparative, Prospective Clinical Study of the Efficacy and Safety of Prenofitol Tablets at Different Doses, With an Open-label Pharmacokinetic Study Phase in Patients With Dyslipidemia.
- ClinicalTrials.gov ID
- NCT07908433
- Acronym / sponsor ID
- 02-PREN-2025
- Conditions
- Dyslipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Nov 2026 (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.
Stage 1 of the Study
Stage 1 of the study will consist of:
a screening period (Visit 0) conducted within 0-14 days prior to the start of treatment; an inpatient treatment period, including Visit 1 (Days 1-4) and Visit 2 (Days 7-8), during which blood samples will be collected for pharmacokinetic (PK) analysis and safety parameters will be assessed.
Upon completion of the inpatient treatment period, the study data will be submitted to the National Center for Medicines and Medical Devices (NCMD) for analysis and assessment of tolerability and safety parameters. Based on the NCMD conclusion, a decision will be made regarding the feasibility of proceeding to Stage 2 of the study.
an outpatient treatment period lasting for the subsequent 83 days (11 weeks), during which safety parameters will be assessed at the following time points: Day 28 (Visit 4), Day 56 (Visit 5), and Day 90 (Visit 7) from the start of treatment. Adverse events (AEs) and serious adverse events (SAEs) will be recorded at the above-mentioned visits and during telephone follow-up contacts at Day 14 (Visit 3) and Day 84 (Visit 6); a follow-up period lasting for the subsequent 90 days (up to Week 24 from the start of treatment). Safety parameters will be assessed by telephone follow-up at Day 120 (Visit 8), Day 150 (Visit 9), and at the final Visit on Day 180 (Visit 10).
The treatment duration will be 90 days, and the follow-up period will be 90 days. The total study duration for each patient will be 180 days (approximately 6 months).
Stage 2 of the Study
Stage 2 of the study will consist of:
a screening period (Visit 0) conducted within 0-14 days prior to the start of treatment; an outpatient treatment period lasting for the subsequent 90 days (12 weeks), during which safety and efficacy parameters and immune status will be assessed at the following time points: Day 1 (Visit 1), Day 7 (Visit 3), Day 28 (Visit 6), and Day 90 (Visit 8). Additional blood samples for immune status assessment will be collected on Day 2 (Visit 2), Day 14 (Visit 4), and Day 21 (Visit 5) from the start of treatment.
AEs and SAEs will be recorded at the above-mentioned visits and during a telephone follow-up contact on Day 56 (Visit 7).
Upon completion of the 90-day treatment period (Visit 8), the study data will be submitted to the National Center for Medicines and Medical Devices (NCMD) for assessment of safety and efficacy parameters.
a follow-up period lasting for the subsequent 90 days (up to Week 24 from the start of treatment), during which safety and efficacy parameters and immune status will be assessed at Day 120 (Visit 9), Day 150 (Visit 10), and at the final Visit on Day 180 (Visit 11).
The treatment duration will be 90 days, and the follow-up period after completion of treatment will be 90 days. The total study duration for each patient will be 180 days (approximately 6 months).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Stage 1. Open-label. Assessment of pharmacokinetics. (Group 1) | Experimental | Drug: 1 tablet of Prenofitol1 tablet of study drug 2 times a day with 12-hour intervals |
| Stage 1. Open-label. Assessment of pharmacokinetics. (Group 2) | Experimental | Drug: 2 tablets of Prenofitol2 tablets of study drug 2 times a day with 12-hour intervals |
| Stage 2. Double-blind, placebo-controlled, randomized, comparative. (Group 3) | Experimental | Drug: 1 tablet of Prenofitol, Drug: 1 tablet of placebo1 tablet of study drug + 1 tablet of placebo, 2 times a day with 12-hour intervals |
| Stage 2. Double-blind, placebo-controlled, randomized, comparative. (Group 4) | Experimental | Drug: 2 tablets of Prenofitol2 tablets of study drug 2 times a day with 12-hour intervals |
| Stage 2. Double-blind, placebo-controlled, randomized, comparative. (Group 5) | Placebo comparator | Drug: 2 tablets of placebo2 tablets of placebo 2 times a day with 12-hour intervals |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Stage 1.
- Patients meeting all of the following criteria will be eligible for inclusion in the study:
- Volunteers of either sex, aged 40 to 69 years (inclusive);
- Provision of signed Informed Consent prior to the initiation of any screening procedures, and, in the Investigator's opinion, the ability to comply with all study requirements;
- Body mass index (BMI) of 18.5-39.9 kg/m² (inclusive);
Key exclusion criteria (40 listed)
- Stage 1.
- Inability to read in Russian; inability or unwillingness to understand the nature of the study. Any other conditions that limit the validity of obtaining informed consent or may affect the patient's ability to participate in the study;
- Significant history of allergic reactions or drug intolerance;
- Acute coronary syndrome or stroke occurring less than 1 year prior to enrollment in the study;
- Use of medicinal products that have a pronounced effect on hemodynamics, liver function, or other relevant functions (e.g., barbiturates, omeprazole, cimetidine, rifampicin, etc.) within 2 months prior to the start of the study;
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 |
|---|---|---|
| 1 tablet of PrenofitolParticipants will receive Prenofitol tablets. 1 tablet, 2 times a day with 12-hour intervals. | Drug | Stage 1. Open-label. Assessment of pharmacokinetics. (Group 1), Stage 2. Double-blind, placebo-controlled, randomized, comparative. (Group 3) |
| 2 tablets of PrenofitolParticipants will receive Prenofitol tablets. 2 tablets, 2 times a day with 12-hour intervals. | Drug | Stage 1. Open-label. Assessment of pharmacokinetics. (Group 2), Stage 2. Double-blind, placebo-controlled, randomized, comparative. (Group 4) |
| 1 tablet of placeboParticipants will receive placebo tablets. 1 tablet, 2 times a day with 12-hour intervals. | Drug | Stage 2. Double-blind, placebo-controlled, randomized, comparative. (Group 3) |
| 2 tablets of placeboParticipants will receive placebo tablets. 2 tablets, 2 times a day with 12-hour intervals. | Drug | Stage 2. Double-blind, placebo-controlled, randomized, comparative. (Group 5) |
Primary outcome
The proportion of patients achieving the target LDL-C level of <3.0 mmol/L compared with the baseline value in the investigational treatment groups and the placebo group at 90 days from the start of treatment (Visit 8).
Time frame: 180 days from the start of treatment
4 secondary outcomes
The proportion of patients achieving a ≥50% reduction in LDL-C from the baseline value in the investigational treatment groups and the placebo group at 90 days from the start of treatment (Visit 8)
Time frame: 180 days from the start of treatment
The proportion of patients achieving a ≥25% reduction in LDL-C from the baseline value in the investigational treatment groups and the placebo group at 90 days from the start of treatment (Visit 8)
Time frame: 180 days from the start of treatment
The proportion of patients achieving an LDL-C level of <3.0 mmol/L compared with the baseline value in the investigational treatment groups and the placebo group
Time frame: 180 days from the start of treatment
The change in lipid metabolism parameters, including triglyceride levels, in the investigational treatment groups and the placebo group
Time frame: 180 days from the start of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1 tablet of Prenofitol and 2 tablets of Prenofitol in people with Dyslipidemia, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation.
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 30 inclusion and 40 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
The proportion of patients achieving the target LDL-C level of <3.0 mmol/L compared with the baseline value in the investigational treatment groups and the placebo group at 90 days from the start of treatment (Visit 8). (time frame: 180 days from the start of treatment). 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 2 Nov 2026.