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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT06723652•Beijing Suncadia Pharmaceuticals Co., Ltd

View on ClinicalTrials.gov

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

Age

12 - No limit years

Sex

ALL

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

Locations (1)

The Second Xiangya Hospital of Central South University Hospital

Changsha, Hunan, China

Key Dates

Start Date

February 13, 2025

Primary Completion Date

August 25, 2025

Completion Date

November 18, 2025

Last Updated

December 15, 2025

Enrollment

ACTUAL participants

Conditions

Homozygous Familial Hypercholesterolemia

Interventions

SHR-1918

DRUG

SHR-1918 placebo

DRUG

The Rogosin Institute Homozygous Familial Hypercholesterolemia Repository

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Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia

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Homozygous Familial Hypercholesterolemia (HoFH)Major Adverse Cardiovascular Events (MACE)+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

The Rogosin Institute Homozygous Familial Hypercholesterolemia Repository

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