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

Status and phase: Completed; Phase 3

Conditions: Homozygous Familial Hypercholesterolemia

Treatments: Drug: SHR-1918; Drug: SHR-1918 placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06723652

SHR-1918-301

Details and patient eligibility

About

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).

Enrollment: 55 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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55 participants in 2 patient groups, including a placebo group

SHR-1918

Experimental group

Treatment:

Drug: SHR-1918

SHR-1918 placebo

Placebo Comparator group

Treatment:

Drug: SHR-1918 placebo