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

NCT07133815 | Not Yet Recruiting Phase 2

• 1 other identifier: SHR-1918-205
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

A multicenter, single arm, open label phase II clinical study evaluating the long-term efficacy and safety of SHR-1918 in homozygous familial hypercholesterolemia patients

Conditions

Homozygous Familial Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• The incidence and severity of adverse events

  during the study period About 48 months，

Study Arms (1)

SHR-1918

EXPERIMENTAL

Drug: SHR-1918

Interventions

SHR-1918 DRUG

SHR-1918

SHR-1918

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide a written informed consent
• Subjects who received and completed the SHR-1918-301 study treatment in previous studies and were deemed to have therapeutic benefits by the researchers

You may not qualify if:

• Known to be allergic to the investigational drug or any component of the investigational drug, or to have experienced severe allergic reactions to other antibody drugs;
• History of malignant tumors in the past 5 years;
• There are serious concurrent diseases
• Pregnant or lactating women;
• The researchers determined that the subjects had poor compliance or any inappropriate factors for participating in this trial

Sponsors & Collaborators

• Beijing Suncadia Pharmaceuticals Co., Ltd: lead

Study Sites (1)

Xiangya Second Hospital of Central South University

Changsha, Hunan, 410007, China

Location

MeSH Terms

Conditions

Homozygous Familial Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipoproteinemia Type II; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Meng Sun

CONTACT

+86 18036618718; meng.sun@hengrui.com

Chao Lyu

CONTACT

+86 13810733217; chao.lv.cl1@hengrui.com

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 14, 2025
• First Posted: August 21, 2025
• Study Start: August 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

CN (1)