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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

804 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-29

Study Completion Date

2022-02-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate Safety and Efficacy of IBI306, a PCSK9 Monoclonal Antibody in Chinese Subjects With Homozygous Familial Hypercholesterolemia

NCT04031742

Homozygous Familial Hypercholesterolemia

COMPLETED PHASE2/PHASE3

Evaluate the Efficacy and Safety of IBI306 in Subjects With Homozygous Familial Hypercholesterolemia

NCT04948008

Familial Hypercholesterolemia - Homozygous Lipid Metabolism Disorders Proprotein Convertase Subtilisin/Kexin 9

UNKNOWN PHASE2/PHASE3

Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 691751 in Healthy Asian Male Volunteers

NCT02057835

Healthy

COMPLETED PHASE1

A Research Study to Evaluate the Safety and Preliminary Efficacy of SGC001 in Patients With Myocardial Infarction

NCT07091929

Anterior Myocardial Infarction

COMPLETED PHASE1

Integrated Biomarker And Imaging Study - 2

NCT00268996

Atherosclerosis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypercholesterolemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IBI306 450mg SC Q4W

Group Type EXPERIMENTAL

IBI306 450mg SC Q4W

Intervention Type DRUG

Subjects will receive IBI306 450mg every 4 weeks subcutaneously.

Placebo SC Q4W

Group Type PLACEBO_COMPARATOR

Placebo SC Q4W

Intervention Type DRUG

Subjects will receive placebo every 4 weeks subcutaneously.

IBI306 600mg SC Q6W

Group Type EXPERIMENTAL

IBI306 600mg SC Q6W

Intervention Type DRUG

Subjects will receive IBI306 600mg every 6 weeks subcutaneously.

Placebo SC Q6W

Group Type PLACEBO_COMPARATOR

Placebo SC Q6W

Intervention Type OTHER

Subjects will receive placebo every 6 weeks subcutaneously.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IBI306 450mg SC Q4W

Subjects will receive IBI306 450mg every 4 weeks subcutaneously.

Intervention Type DRUG

Placebo SC Q4W

Subjects will receive placebo every 4 weeks subcutaneously.

Intervention Type DRUG

IBI306 600mg SC Q6W

Subjects will receive IBI306 600mg every 6 weeks subcutaneously.

Intervention Type DRUG

Placebo SC Q6W

Subjects will receive placebo every 6 weeks subcutaneously.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

1. Diagnosis of HoFH or HeFH
2. Uncontrolled hypertension
3. Uncontrolled hyperthyroidism or hypothyroidism
4. Severe renal dysfunction
5. Known sensitivity to any of the products to be administered during dosing

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No