Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia

Beijing Suncadia Pharmaceuticals Co., Ltd26 enrolled

Overview

This is a single-arm, open-label study to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by SHR-1918 in patients with homozygous familial hypercholesterolemia (HoFH).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Homozygous Familial Hypercholesterolemia

Interventions

SHR-1918DRUG

Three administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diagnosis of functional HoFH by either genetic or clinical criteria as defined in the protocol 2. LDL-C ≥2.6mmol/L at the screening visit 3. Body weight ≥40 kg 4. Receiving stable lipid-lowering therapy for at least 28 days before enrollment. Exclusion Criteria: 1. Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening (HbA1c \> 8.5%) 2. eGFR \<30ml/min/1.73m2 at the screening visit 3. CK \>5times ULN at the screening visit

Locations (1)

The Second Xiangya Hospital of Central South University Hospital

Changsha, Hunan, China

Outcomes

Primary Outcomes

Percent change in calculated LDL-C from baseline to week 12

Time frame: from baseline to week 12

Secondary Outcomes

Change in calculated LDL-C from baseline to week 12

Time frame: from baseline to week 12

Data from ClinicalTrials.gov

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