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 3

Recruiting

• Conditions: Homozygous Familial Hypercholesterolemia
• Interventions: Drug: SHR-1918; Drug: SHR-1918 placebo

• Registration Number: NCT06723652
• Lead Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-04
• Study First Posted: 2024-12-09
• Study Start: 2025-02-13
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-20
• Primary Completion: 2025-05
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR-1918	SHR-1918	-
SHR-1918 placebo	SHR-1918 placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Second Xiangya Hospital of Central South University Hospital; 🇨🇳 Changsha, Hunan, China