Status:
COMPLETED
Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia
Lead Sponsor:
Beijing Suncadia Pharmaceuticals Co., Ltd
Conditions:
Homozygous Familial Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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).
Eligibility Criteria
Inclusion
- Diagnosis of functional HoFH by either genetic or clinical criteria as defined in the protocol
- LDL-C ≥2.6mmol/L at the screening visit
- Body weight ≥40 kg
- Receiving stable lipid-lowering therapy for at least 28 days before enrollment.
Exclusion
- Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening (HbA1c \> 8.5%)
- eGFR \<30ml/min/1.73m2 at the screening visit
- CK \>5times ULN at the screening visit
Key Trial Info
Start Date :
December 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2024
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06009393
Start Date
December 22 2023
End Date
August 23 2024
Last Update
September 5 2025
Active Locations (1)
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1
The Second Xiangya Hospital of Central South University Hospital
Changsha, Hunan, China, 410007