A Study of IBI306 in Participants With Hypercholesterolemia

Innovent Biologics (Suzhou) Co. Ltd.306 enrolled

Overview

This study is designed for multi-center, double-blind, randomized, placebo-controlled phase III trial to evaluate the safety and tolerability of subcutaneous injection of IBI306 in hypercholesterolemia patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

306

Conditions

Hypercholesterolemia

Interventions

IBI306DRUG

Recombinant humanized Anti- PCSK9 monoclonal antibody, administered SC from BL to week 24

PlaceboDRUG

Recombinant humanized Anti- PCSK9 monoclonal antibody, administered SC from BL to week 24

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Peking University First Hospital

Beijing, China

Outcomes

Primary Outcomes

1. Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at weeks 12

Time frame: Baseline to week12

Secondary Outcomes

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

Time frame: Baseline to week24

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

Time frame: Baseline to week24

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

Time frame: Baseline to week24

Data from ClinicalTrials.gov

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