Completed

A Single-Arm, Open-Label, Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia

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What is being tested

SHR-1918

Drug
Who is being recruted

Homozygous Familial Hypercholesterolemia+9

+ Hyperlipoproteinemia Type II

+ Hyperlipidemias

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: December 2023
See protocol details

Summary

Principal SponsorBeijing Suncadia Pharmaceuticals Co., Ltd
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 22, 2023

Actual date on which the first participant was enrolled.

This clinical study focuses on testing a drug called SHR-1918 to see how effective it is in lowering "bad" cholesterol, also known as low-density lipoprotein cholesterol (LDL-C), in people who have homozygous familial hypercholesterolemia (HoFH). HoFH is a rare genetic condition where individuals inherit a tendency for high cholesterol levels from both parents, which can lead to serious heart problems. This study is important because it aims to find a better treatment for lowering LDL-C in these patients, potentially reducing their risk of heart disease and improving their quality of life. In this study, participants with HoFH will receive the drug SHR-1918. The study is open-label, meaning both the researchers and participants will know they are receiving this specific treatment, and it is single-arm, meaning all participants receive the same treatment without a comparison group. The main focus is to measure how much the levels of LDL-C decrease, helping researchers understand the drug's effectiveness. While the study does not list specific risks or benefits, participants will be closely monitored to ensure their safety and to observe the drug's effects.

Official TitleA Single-Arm, Open-Label, Phase II Clinical Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia
NCT06009393
Principal SponsorBeijing Suncadia Pharmaceuticals Co., Ltd
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

26 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Homozygous Familial HypercholesterolemiaHyperlipoproteinemia Type IIHyperlipidemiasHyperlipoproteinemiasLipid Metabolism, Inborn ErrorsMetabolic DiseasesMetabolism, Inborn ErrorsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNutritional and Metabolic DiseasesGenetic Diseases, InbornDyslipidemiasLipid Metabolism Disorders

Criteria

4 inclusion criteria required to participate
Diagnosis of functional HoFH by either genetic or clinical criteria as defined in the 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.

3 exclusion criteria prevent from participating
Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening (HbA1c > 8.5%)

eGFR <30ml/min/1.73m2 at the screening visit

CK >5times ULN at the screening visit

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

The Second Xiangya Hospital of Central South University Hospital

Changsha, ChinaOpen The Second Xiangya Hospital of Central South University Hospital in Google Maps
CompletedOne Study Center