Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04759534
Study type Interventional
Source Shenzhen People's Hospital
Contact
Status Active, not recruiting
Phase Phase 3
Start date September 10, 2020
Completion date November 30, 2021

See also
  Status Clinical Trial Phase
Completed NCT03563547 - Effects of Soy Protein on Cholesterol Levels in Children Affected With Familial Hypercholesterolemia N/A
Terminated NCT03694197 - Long Term Safety Study of PRALUENT Phase 4
Completed NCT01968980 - A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia Phase 3
Completed NCT00171236 - Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia Phase 3
Completed NCT03397121 - Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH) Phase 3
Completed NCT04173793 - A Study of PCSK9 Inhibitor AK102 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Phase 2
Not yet recruiting NCT06164730 - A Study of VERVE-102 in Patients With Familial Hypercholesterolemia or Premature Coronary Artery Disease Phase 1
Completed NCT02326220 - Study of Alirocumab (REGN727/SAR236553) in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Undergoing Low-density Lipoprotein (LDL) Apheresis Therapy Phase 3
Completed NCT02392559 - Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders Phase 3
Completed NCT02460159 - A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-384) Phase 3
Terminated NCT01583647 - A Study of Extended-release (ER) Niacin/Laropiprant in Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0524A-158) Phase 1
Active, not recruiting NCT05398029 - A Study of VERVE-101 in Patients With Familial Hypercholesterolemia and Cardiovascular Disease Phase 1
Completed NCT00706849 - Efficacy and Safety Study of ISIS 301012 (Mipomersen) as Add-on in Familial Hypercholesterolemic Patients With Coronary Artery Disease Phase 3
Completed NCT04666298 - Study of Efficacy and Safety of Inclisiran in Japanese Participants With High Cardiovascular Risk and Elevated LDL-C Phase 2
Completed NCT01515241 - Exploratory Study of Plaque Regression Phase 2
Completed NCT03038022 - Study of MGL-3196 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) Phase 2
Completed NCT01576484 - Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH) Phase 2
Terminated NCT00151788 - Efficacy and Safety of the ACAT Inhibitor CS-505 (Pactimibe) for Reducing the Progression of Carotid Artery Disease. This Study is Also Known as CAPTIVATE. Phase 2/Phase 3
Completed NCT05325203 - A Study to Evaluate the Efficacy and Safety of JS002 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH). Phase 3
Completed NCT01709500 - Study of Alirocumab (REGN727/SAR236553) in Patients With heFH (Heterozygous Familial Hypercholesterolemia) Who Are Not Adequately Controlled With Their LMT (Lipid-Modifying Therapy) Phase 3