Gene PolymorphismNCT06641661
NPC1L1 Gene Polymorphism and the Efficacy and Safety of Hybutimibe
An observational study of Gene Polymorphism and ASCVD, run by Qianfoshan Hospital.
Trial summary
Significant individual differences may lead to differences in patients' responses to drug therapy and lead to an increased incidence of adverse reactions. However, there are currently very limited data on the genetic variation of the NPC1L1 gene in the Chinese population. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gene Polymorphism, ASCVD
- What is being tested?
- Hybutimibe 10mg QD
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to Jun 2027
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at high/very high risk of ASCVD who were treated with only moderate-intensity statins for at least 8 weeks before enlistment and whose LDL-C levels did not meet the lipid reduction target corresponding to the risk stratification level of ASCVD recommended by the Chinese Lipid Management Guidelines (2023) and who needed to be combined with Hybutimibe.
Who may be able to join
- Patients with high/very high risk of ASCVD were only treated with moderate intensity statins (including atorvastatin 10-20mg, rosuvastatin 5-10mg, fluvastatin 80mg, lovastatin 40mg, pivastatin 1-4mg, pravastatin 40mg, simvastatin 20-40mg, etc.) for at least 8 weeks before enlistment.
- The LDL-C level did not meet the lipid reduction target corresponding to the risk stratification level of ASCVD recommended by the Chinese Lipid Management Guidelines (2023), or the level of LDL-C was still not up to the standard as clinicians expected that patients should continue to use medium-dose statins for lipid-lowering treatment alone, and the cholesterol absorption inhibitor Hybomab should be combined;
- Age 18-75 years old;
- BMI range 22-45 kg/m2;
- Can understand and voluntarily sign informed consent.
Who cannot join
- Allergic history of cholesterol absorption inhibitors and statins;
- other types of cholesterol absorption inhibitors have been used;
- Homozygous familial hypercholesterolemia;
- any clinically serious endocrine disease affecting blood lipids or lipid proteins;
- Abnormal liver function with AST or ALT greater than three times the upper limit of normal, or bilirubin >34uM, creatine muscle enzyme greater than five times the upper limit of normal, or evidence of serologically infectious liver disease;
- Thyroid dysfunction;
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- History of malignant tumor;
- Patients with coagulation dysfunction;
- Women who are pregnant or planning to become pregnant;
- Taking fenofibrate, gefilozil, probucol, warfarin, glucocorticoids, cyclosporine or another immunosuppressant within 30 days prior to the trial;
- can not adhere to medication or regular follow-up;
- Communication disorders, people with severe aphasia, audio-visual impairment, serious mental illness, and difficulty cooperating with investigators;
- There are other circumstances that the researcher considers inappropriate to participate in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
mei Gao, Doctor contact
About this study
Official title: The Association Between NPC1L1 Gene Polymorphism and the Efficacy and Safety of Hybutimibe in High/very High Risk ASCVD Patients
Significant individual differences may lead to differences in patients' responses to drug therapy and lead to an increased incidence of adverse reactions. However, there are currently very limited data on the genetic variation of the NPC1L1 gene in the Chinese population. In view of the important role of NPC1L1 gene polymorphism in cholesterol absorption, lipid profile, coronary heart disease prevalence and ezetimibe response, it is necessary to focus on the allele frequency analysis of NPC1L1 gene polymorphism in the Chinese population, and to further explore the therapeutic response of NPC1L1 gene polymorphism and Hybutimibe.
With reference to previous domestic and foreign literature reports and HapMap project (http://hapmap.ncbi.nlm. nih.gov/)SNP) distribution, this study selected NPC1L1 gene loci with relatively in-depth clinical research. rs2072183, rs4720470, rs2073547 were analyzed. The minimum allele frequency (MAF) of the above loci were all greater than 10%, and it has been confirmed that genetic variation exists between different diseases and different races, which may affect the lipid profile , the risk of coronary heart disease and the response to hybomaib treatment. However, the variability of rs2072183 in response to Hybutimibe needs to be further verified, and the effects of rs4720470 and rs2073547 gene polymorphisms on drug response also need to be targeted. In order to further determine the correlation between the distribution of NPC1L1 polymorphism and the efficacy and safety of Hybutimibe, we conducted this study to observe the distribution frequency of NPC1L1 gene polymorphisms at rs2072183, rs4720470 and rs2073547 in high-risk/extremely high-risk ASCVD patients. To explore the correlation between NPC1L1 gene polymorphisms and the efficacy and safety of Hybutimibe combined with moderate-intensity statins in the treatment of high-risk/very high-risk ASCVD patients. This is the first time to explore the distribution of NPC1L1 polymorphism in high/very high risk ASCVD population in China, which will provide genetic evidence for the correct use of Hybutimibe and moderate intensity statin therapy, and provide further evidence-based medical evidence for the distribution of NPC1L1 polymorphism and the efficacy and safety of Hybutimibe.
- Conditions
- Gene Polymorphism, ASCVD
- Being tested
- Hybutimibe 10mg QD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybutimibe 10mg QDDrug
Hybutimibe was added to the conventional treatment
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Hybutimibe 10mg QD was added to the conventional treatment Receives: Drug: Hybutimibe 10mg QD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of LDL-C change from baseline at week 12 of treatment
Rate of LDL-C change from baseline in high-risk/very high-risk ASCVD patients at week 12 of treatment
Measured: at week 12 of treatment
Secondary outcomes (4)
At the 4th week of treatment, LDL-C change rate from baseline in high-risk/very high-risk ASCVD patients
At the 4th week of treatment, LDL-C change rate from baseline in high-risk/very high-risk ASCVD patients
Measured: At the 4th week of treatment
Changes in HDL-C, TC and TG levels at the 4th and 12th week of treatment.
Changes in HDL-C, TC and TG levels at the 4th and 12th week of treatment.
Measured: at the 4th and 12th week of treatment
Changes in levels of alanine aminotransferase, aspartate aminotransferase and creatine kinase at the 4th and 12th week of treatment.
Changes in levels of alanine aminotransferase, aspartate aminotransferase and creatine kinase at the 4th and 12th week of treatment.
Measured: at the 4th and 12th week of treatment
Polymorphism and distribution frequency of NPC1L1 gene rs2072183, rs4720470 and rs2073547 in high-risk/extremely high-risk ASCVD patients.
Polymorphism and distribution frequency of NPC1L1 gene rs2072183, rs4720470 and rs2073547 in high-risk/extremely high-risk ASCVD patients.
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gene PolymorphismStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Micro Love Public Welfare Foundation
- Responsible party
- Principal investigator, Mei Gao, Qianfoshan Hospital
- Investigators
- mei Gao, Doctor, Study chair, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641661
- Sponsor's protocol ID
- YXLL-KY-2024（067)
- Status last verified
- Jul 2024
- First submitted
- 11 Oct 2024
- Last updated
- 15 Oct 2024
- 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between NPC1L1 Gene Polymorphism and the Efficacy and Safety of Hybutimibe in High/very High Risk ASCVD Patients
- ClinicalTrials.gov ID
- NCT06641661
- Acronym / sponsor ID
- YXLL-KY-2024（067)
- Conditions
- Gene Polymorphism, ASCVD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Collaborators
- Beijing Micro Love Public Welfare Foundation
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Oct 2024 (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.
Significant individual differences may lead to differences in patients' responses to drug therapy and lead to an increased incidence of adverse reactions. However, there are currently very limited data on the genetic variation of the NPC1L1 gene in the Chinese population. In view of the important role of NPC1L1 gene polymorphism in cholesterol absorption, lipid profile, coronary heart disease prevalence and ezetimibe response, it is necessary to focus on the allele frequency analysis of NPC1L1 gene polymorphism in the Chinese population, and to further explore the therapeutic response of NPC1L1 gene polymorphism and Hybutimibe.
With reference to previous domestic and foreign literature reports and HapMap project (http://hapmap.ncbi.nlm. nih.gov/)SNP) distribution, this study selected NPC1L1 gene loci with relatively in-depth clinical research. rs2072183, rs4720470, rs2073547 were analyzed. The minimum allele frequency (MAF) of the above loci were all greater than 10%, and it has been confirmed that genetic variation exists between different diseases and different races, which may affect the lipid profile , the risk of coronary heart disease and the response to hybomaib treatment. However, the variability of rs2072183 in response to Hybutimibe needs to be further verified, and the effects of rs4720470 and rs2073547 gene polymorphisms on drug response also need to be targeted. In order to further determine the correlation between the distribution of NPC1L1 polymorphism and the efficacy and safety of Hybutimibe, we conducted this study to observe the distribution frequency of NPC1L1 gene polymorphisms at rs2072183, rs4720470 and rs2073547 in high-risk/extremely high-risk ASCVD patients. To explore the correlation between NPC1L1 gene polymorphisms and the efficacy and safety of Hybutimibe combined with moderate-intensity statins in the treatment of high-risk/very high-risk ASCVD patients. This is the first time to explore the distribution of NPC1L1 polymorphism in high/very high risk ASCVD population in China, which will provide genetic evidence for the correct use of Hybutimibe and moderate intensity statin therapy, and provide further evidence-based medical evidence for the distribution of NPC1L1 polymorphism and the efficacy and safety of Hybutimibe.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Drug: Hybutimibe 10mg QDHybutimibe 10mg QD was added to the conventional treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at high/very high risk of ASCVD who were treated with only moderate-intensity statins for at least 8 weeks before enlistment and whose LDL-C levels did not meet the lipid reduction target corresponding to the risk stratification level of ASCVD recommended by the Chinese Lipid Management Guidelines (2023) and who needed to be combined with Hybutimibe.
Key inclusion criteria (5 listed)
- Patients with high/very high risk of ASCVD were only treated with moderate intensity statins (including atorvastatin 10-20mg, rosuvastatin 5-10mg, fluvastatin 80mg, lovastatin 40mg, pivastatin 1-4mg, pravastatin 40mg, simvastatin 20-40mg, etc.) for at least 8 weeks before enlistment.
- The LDL-C level did not meet the lipid reduction target corresponding to the risk stratification level of ASCVD recommended by the Chinese Lipid Management Guidelines (2023), or the level of LDL-C was still not up to the standard as clinicians expected that patients should continue to use medium-dose statins for lipid-lowering treatment alone, and the cholesterol absorption inhibitor Hybomab should be combined;
- Age 18-75 years old;
- BMI range 22-45 kg/m2;
- Can understand and voluntarily sign informed consent.
Key exclusion criteria (13 listed)
- Allergic history of cholesterol absorption inhibitors and statins;
- other types of cholesterol absorption inhibitors have been used;
- Homozygous familial hypercholesterolemia;
- any clinically serious endocrine disease affecting blood lipids or lipid proteins;
- Abnormal liver function with AST or ALT greater than three times the upper limit of normal, or bilirubin >34uM, creatine muscle enzyme greater than five times the upper limit of normal, or evidence of serologically infectious liver disease;
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 |
|---|---|---|
| Hybutimibe 10mg QDHybutimibe was added to the conventional treatment | Drug | Experimental group |
Primary outcome
Rate of LDL-C change from baseline at week 12 of treatment
Time frame: at week 12 of treatment
Rate of LDL-C change from baseline in high-risk/very high-risk ASCVD patients at week 12 of treatment
4 secondary outcomes
At the 4th week of treatment, LDL-C change rate from baseline in high-risk/very high-risk ASCVD patients
Time frame: At the 4th week of treatment
Changes in HDL-C, TC and TG levels at the 4th and 12th week of treatment.
Time frame: at the 4th and 12th week of treatment
Changes in levels of alanine aminotransferase, aspartate aminotransferase and creatine kinase at the 4th and 12th week of treatment.
Time frame: at the 4th and 12th week of treatment
Polymorphism and distribution frequency of NPC1L1 gene rs2072183, rs4720470 and rs2073547 in high-risk/extremely high-risk ASCVD patients.
Time frame: at enrollment
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 15 Oct 2024.
- 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.
mei Gao, Doctor contact
mei Gao, Doctor study chair
Shandong First Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Gene Polymorphism and ASCVD, run by Qianfoshan Hospital.
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 13 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 15 Oct 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact zhongsu Wang, Doctor (15969694663, wangzhongsu2016@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of LDL-C change from baseline at week 12 of treatment (time frame: at week 12 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 15 Oct 2024.