MedTrace Logo

NPC1L1 Gene Polymorphism and the Efficacy and Safety of Hybutimibe

NCT06641661 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2024-10-15

No results posted yet for this study

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. 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

Interventions

DRUG

Hybutimibe 10mg QD

Hybutimibe was added to the conventional treatment

Sponsors & Collaborators

  • Beijing Micro Love Public Welfare Foundation

    collaborator UNKNOWN

  • Qianfoshan Hospital

    lead OTHER

Principal Investigators

  • mei Gao, Doctor · Shandong First Medical University

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2026-12-31
Completion
2027-06-30

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06641661 on ClinicalTrials.gov