CompletedPhase 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

China55 participantsStarted 2025-02-13

Plain-language 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).

Who can participate

Age range12 Years

SexALL

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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

What they're measuring

Percent change in calculated LDL-C from baseline to week 12

Timeframe: week 12

Trial details

NCT IDNCT06723652

SponsorBeijing Suncadia Pharmaceuticals Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-25

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