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

Phase

Condition

Hypercholesterolemia

Familial Hypercholesterolemia

Treatment

SHR-1918

SHR-1918 placebo

Clinical Study ID

NCT06723652

SHR-1918-301

Ages > 12
All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

Diagnosis of functional HoFH by either genetic or clinical criteria as defined inthe 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

Exclusion Criteria:

Treatment with an ANGPTL3 inhibitor within 24 weeks prior before screening
Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes atscreening (HbA1c > 8.5%)
eGFR <30ml/min/1.73m2 at the screening visit
CK >5times ULN at the screening visit

Study Design