Homozygous Familial Hypercholesterolemia
Conditions
Brief summary
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).
Interventions
DRUGSHR-1918
Three administration
Sponsors
Beijing Suncadia Pharmaceuticals Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in calculated LDL-C from baseline to week 12 | from baseline to week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Change in calculated LDL-C from baseline to week 12 | from baseline to week 12 |
Countries
China
Outcome results
None listed