Evaluate the Efficacy and Safety of SHR-1918 in Patients... | NCT06009393

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

NCT06009393

Sponsor

Beijing Suncadia Pharmaceuticals Co., Ltd

Status

Completed

Last Update Posted

Sep 5, 2025Actual

Enrollment

26Actual

Phase

Phase 2

Conditions

Homozygous Familial Hypercholesterolemia

Interventions

SHR-1918

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 22, 2023Actual

Primary Completion Date

Jun 29, 2024Actual

Completion Date

Aug 23, 2024Actual

First Submitted Date

Aug 15, 2023

First Submission Date that Met QC Criteria

Aug 22, 2023

First Posted Date

Aug 24, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2025

Last Update Posted Date

Sep 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Label	Type	Description	Intervention Names
SHR-1918	Experimental		Drug: SHR-1918

Name	Type	Description	Arm Group Labels	Other Names
SHR-1918	Drug	Three administration	SHR-1918

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent change in calculated LDL-C from baseline to week 12		from baseline to week 12

Secondary Outcomes

Measure	Description	Time Frame
Change in calculated LDL-C from baseline to week 12		from baseline to week 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Second Xiangya Hospital of Central South University Hospital		Changsha	Hunan	410007	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41499141	Derived	Peng D, Wang L, Pi L, Xu Y, Chen J, Wu Y, Wang N, Chen X, Qi S, Feng S, Cheng G, Lv C, Zhu M, Zhu Y. Anti-ANGPTL3 Antibody SHR-1918 for Homozygous Familial Hypercholesterolemia: A Nonrandomized Clinical Trial. JAMA Cardiol. 2026 Feb 1;11(2):193-198. doi: 10.1001/jamacardio.2025.4878.

ID	Term
D006938	Hyperlipoproteinemia Type II
D008052	Lipid Metabolism, Inborn Errors
D008661	Metabolism, Inborn Errors
D030342	Genetic Diseases, Inborn