A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia
NCT ID: NCT06723652
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
55 participants
INTERVENTIONAL
2025-02-13
2025-11-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SHR-1918
SHR-1918
six administration
SHR-1918 placebo
SHR-1918 placebo
SHR-1918 placebo three administration+SHR-1918 three administration
Interventions
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SHR-1918
six administration
SHR-1918 placebo
SHR-1918 placebo three administration+SHR-1918 three administration
Eligibility Criteria
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Inclusion Criteria
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
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
12 Years
ALL
No
Sponsors
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Beijing Suncadia Pharmaceuticals Co., Ltd
INDUSTRY
Responsible Party
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Locations
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The Second Xiangya Hospital of Central South University Hospital
Changsha, Hunan, China
Countries
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Other Identifiers
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SHR-1918-301
Identifier Type: -
Identifier Source: org_study_id
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