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

NCT ID: NCT06009393

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-22

Study Completion Date

2024-08-23

Brief Summary

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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

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Conditions

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Homozygous Familial Hypercholesterolemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SHR-1918

Group Type EXPERIMENTAL

SHR-1918

Intervention Type DRUG

Three administration

Interventions

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SHR-1918

Three administration

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Suncadia Pharmaceuticals Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Second Xiangya Hospital of Central South University Hospital

Changsha, Hunan, China

Site Status

Countries

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China

Other Identifiers

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SHR-1918-202

Identifier Type: -

Identifier Source: org_study_id

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