NCT06723652CompletedPhase 3
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
Beijing Suncadia Pharmaceuticals Co., Ltd1 site in 1 country55 target enrollmentStarted: February 13, 2025Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Percent change in calculated LDL-C from baseline to week 12
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •Treatment with an ANGPTL3 inhibitor within 24 weeks prior before screening
- •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
Arms & Interventions
SHR-1918
Experimental
Intervention: SHR-1918 (Drug)
SHR-1918 placebo
Placebo Comparator
Intervention: SHR-1918 placebo (Drug)
Outcomes
Primary Outcomes
Percent change in calculated LDL-C from baseline to week 12
Time Frame: week 12
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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