NCT06009393

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

December 22, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2024

Completed
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

August 15, 2023

Last Update Submit

August 29, 2025

Conditions

Homozygous Familial Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • Percent change in calculated LDL-C from baseline to week 12

    from baseline to week 12

Secondary Outcomes (1)

  • Change in calculated LDL-C from baseline to week 12

    from baseline to week 12

Study Arms (1)

SHR-1918

EXPERIMENTAL
Drug: SHR-1918

Interventions

SHR-1918DRUG

Three administration

SHR-1918

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Xiangya Hospital of Central South University Hospital

Changsha, Hunan, 410007, China

Location

Related Publications (1)

  • 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 Jan 7. doi: 10.1001/jamacardio.2025.4878. Online ahead of print.

    PMID: 41499141DERIVED

MeSH Terms

Conditions

Homozygous Familial Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipoproteinemia Type IILipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2023

First Posted

August 24, 2023

Study Start

December 22, 2023

Primary Completion

June 29, 2024

Study Completion

August 23, 2024

Last Updated

September 5, 2025

Record last verified: 2025-08

Locations

CN(1)