MedTrace Logo

Application of PCSK9 Inhibitors in Patients With Heterozygous Familial Hypercholesterolemia

NCT04759534 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-08-25

No results posted yet for this study

Summary

This study plans to enroll several patients with heterozygous familial hypercholesterolemia, randomly assigned to different dose groups, and randomly receiving subcutaneous injection of IBI306150 mg or placebo every two weeks: or subcutaneous injection of IBI306 450mg every four weeks (n=49) or placebo (n=25) treatment, treatment lasted for 12 weeks. During randomization, the LDL-C level (\<4.8mmol/L or ≥4.8mmol/L) observed during the screening period visit (VI), and whether ezetimibe was used for stratification. After 12 weeks, each group entered the 12-week open-period treatment, in which subjects in the IBI306 group continued to receive IBI306 treatment, and subjects in the placebo group stopped using placebo and received IBI306 treatment. The exploratory endpoint is the population pharmacokinetic characteristics of IBI306 in Chinese heterozygous familial hypercholesterolemia population.

Conditions

  • Efficacy and Safety
  • Heterozygous Familial Hypercholesterolemia
  • PCSK9

Interventions

BIOLOGICAL

protein convertase subtilisin/kexin type 9 inhibitor

IBI306 is a kind of protein convertase subtilisin/kexin type 9 inhibitor.Received abdominal subcutaneous injection of IBI306 150 mg Q2W or 300 mg Q4W

Sponsors & Collaborators

  • Innovent Biopharmaceutical Co., Ltd.

    collaborator UNKNOWN

  • Shenzhen People's Hospital

    lead OTHER

Principal Investigators

  • dong shaohong, doctor · Shenzhen People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-10
Primary Completion
2021-10-30
Completion
2021-11-30

Countries

  • China

Study Locations

More Related Trials

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 NCT04759534 on ClinicalTrials.gov