Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia

Phase 2

Not yet recruiting

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

• Registration Number: NCT06009393
• Lead Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

Brief Summary

This is a single-arm, open-label 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: 2023-08
• Study First Submitted: 2023-08-15
• Study First Submitted QC: 2023-08-22
• Last Update Submitted: 2023-08-22
• Study First Posted: 2023-08-24
• Last Update Posted: 2023-08-24
• Study Start: 2023-09-24
• Primary Completion: 2024-06-23
• Study Completion: 2024-08-18

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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. Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening (HbA1c > 8.5%)
2. eGFR <30ml/min/1.73m2 at the screening visit
3. CK >5times ULN at the screening visit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR-1918	SHR-1918	-

Primary Outcome Measures

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

Secondary Outcome Measures

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