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

Innovent Biologics (Suzhou) Co. Ltd.18 enrolled

Overview

A study to evaluate safety and efficacy of IBI306 in subjects with homozygous familial hypercholesterolemia.

This is a phase 2b/3 study to assess the efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia. Part 1 is an open-label, two-arm, multicenter pilot study to evaluate efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia. Part 2 is an open-label, single-arm, multicenter study to evaluate efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Homozygous Familial Hypercholesterolemia

Interventions

IBI306BIOLOGICAL

Administered by subcutaneous injection

IBI306BIOLOGICAL

Administered by subcutaneous injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Males and females ≥ 18 to ≤ 80 years of age 2. Diagnosis of homozygous familial hypercholesterolemia 3. LDL cholesterol ≥ 130 mg/dL (3.4mmol/L) 4. Triglyceride ≤ 400 mg/dL (4.5 mmol/L) 5. Bodyweight of ≥ 40 kg at screening Exclusion Criteria: 1. History of liver transplant 2. Uncontrolled hypertension 3. Moderate to severe renal dysfunction 4. Active liver disease or hepatic dysfunction 5. Known sensitivity to any of the products to be administered during dosing

Locations (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

Outcomes

Primary Outcomes

Part 1: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C).

Time frame: Baseline and Week 12

Part 2: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)

Time frame: Baseline and Week 12

Data from ClinicalTrials.gov

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