NCT04759534

Application of PCSK9 Inhibitors in Patients With Heterozygous Familial Hypercholesterolemia

Phase III Clinical Study to Evaluate the Efficacy and Safety of PCSK9 Inhibitors in the Prevention of Chinese Heterozygous Familial Hypercholesterolemia

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Shenzhen People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study plans to enroll 148 patients with heterozygous familial hypercholesterolemia, and maintain a low-fat diet and stably take the current anterior-lowering therapy for at least 4 weeks. Randomly enter different dose groups at 1:1. 2: 1 randomized to receive subcutaneous injection of IBI306150 mg (n=49) or placebo (n=25) every two weeks: or subcutaneous injection of IBI306 450mg (n=49) or placebo (n=25) every four weeks , The treatment lasted 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 primary endpoint was the percentage change in LDL-C levels from baseline at 12 weeks. The secondary endpoints were the changes in blood lipid levels from baseline at 12 and 24 weeks, drug safety, and immunogenicity. The exploratory endpoint is the population pharmacokinetic characteristics of IBI306 in Chinese heterozygous familial hypercholesterolemia population. If necessary, the dose of IBI306 will be adjusted according to the results of the ongoing multi-dose climbing study. After the open period, the subjects will undergo an 8-week safety visit.

Conditions

• Efficacy and Safety
• Heterozygous Familial Hypercholesterolemia
• PCSK9

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-09-10
• Primary completion: 2021-10-30
• Completion: 2021-11-30
• First posted: 2021-02-18
• Last updated: 2021-08-25

Locations

1 site across 1 country: China