Homozygous Familial Hypercholesterolemia
Conditions
Brief summary
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical 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
six administration
DRUGSHR-1918 placebo
SHR-1918 placebo three administration+SHR-1918 three administration
Sponsors
Beijing Suncadia Pharmaceuticals Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 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. Treatment with an ANGPTL3 inhibitor within 24 weeks prior before screening 2. Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening (HbA1c \> 8.5%) 3. eGFR \<30ml/min/1.73m2 at the screening visit 4. CK \>5times ULN at the screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in calculated LDL-C from baseline to week 12 | week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Change in calculated LDL-C from baseline to week 12 | week 12 |
| Percent change and changer in calculated LDL-C from baseline to week 24 | week 24 |
Countries
China
Outcome results
None listed