Skip to main content
OpenTrials
Completed

NCT Number: NCT04289285

Safety and Efficacy of IBI306 in Chinese Subjects With Non-familial Hypercholesterolemia

IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK-9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol(LDL-C) uptake. This study is being done to investigate the effects of IBI306 in Chinese people with non-familial hypercholesterolemia with very high or high cardiovascular risk. This study will see if IBI306 will reduce low density lipoprotein cholesterol (LDL-C) in Chinese people who are taking a certain type of lipid-lowering medication (statins with or without ezetimibe) and whether it causes any side effects

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University First Hospital

Beijing, China

About this study

This is a phase 3, multicenter, double-blind, randomized, placebo-controlled study of IBI306 in Chinese non-familial hypercholesterolemia Subjects with very high or high cardiovascular risk. A total of around 600 subjects who meet admission criteria will be randomized and receive one of the two dose levels of IBI306 or matching placebo: 450mg Q4W, or 600mg Q6W. The double blind period for both groups will be 48 weeks. The study will last 52 weeks

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females ≥ 18 to ≤ 75 years of age
  • Diagnosis of hypercholesterolemia
  • LDL cholesterol ≥ 70 mg/dl (1.8mmol/L)
  • Very high or high cardiovascular risk
  • TG≤500 mg/dL(5.64 mmol/L)

Exclusion criteria

  • Diagnosis of HoFH or HeFH
  • Uncontrolled hypertension
  • Uncontrolled hyperthyroidism or hypothyroidism
  • Severe renal dysfunction
  • Known sensitivity to any of the products to be administered during dosing

Treatment and study plan

IBI306 450mg SC Q4W

Drug

Subjects will receive IBI306 450mg every 4 weeks subcutaneously.

Placebo SC Q4W

Drug

Subjects will receive placebo every 4 weeks subcutaneously.

IBI306 600mg SC Q6W

Drug

Subjects will receive IBI306 600mg every 6 weeks subcutaneously.

Placebo SC Q6W

Other

Subjects will receive placebo every 6 weeks subcutaneously.

Primary outcomes

  1. Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at week 48

    Time frame: Week 48

Secondary outcomes

  1. The percent of subjects with LDL-C reduction no less than 50% from baseline

    Time frame: Week 48

  2. The percent of subjects with LDL-C<70mg/dL(1.8 mmol/L)

    Time frame: Week 48

  3. The percent change in Lp(a),ApoB, non-HDL-c, ApoB/ApoA1 from baseline

    Time frame: Week 48

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

Safety and Efficacy of IBI306 in Chinese Non-familial Hypercholesterolemia Subjects at Very High or High Cardiovascular Risk: a Randomized, Double-blind and Placebo-controlled Phase III Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 28, 2020
Registry last updated
Apr 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.