A Study to Determine the Safety, Tolerability, and Efficacy of SHR-1209 in Patients With Familial Hypercholesterolemia

NCT04455581 | Unknown Phase 2

• 1 other identifier: SHR-1209-201
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is being conducted to evaluate the efficacy, safety and tolerability of SHR-1209 in subjects with familial hypercholesterolemia. 8 eligible patients (aged ≥18 years) with familial hypercholesterolemia, on stable maximum tolerable dose lipid-regulating therapy for at least 28 days, to receive subcutaneous SHR-1209, follow up 8 weeks. The primary endpoint was percentage change in LDL cholesterol from baseline at week 12 .

Conditions

Familial Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Percent Change from Baseline in LDL-C at Week 12

  Week 12

Secondary Outcomes (19)

• Change From Baseline in LDL-C at Week 12

  Week 12

• Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12

  Weeks 10 and 12

• Change From Baseline in LDL-C at the Mean of Weeks 10 and 12

  Weeks 10 and 12

• Percent Change From Baseline in the Total Cholesterol at the Mean of Weeks 10 and 12

  Weeks 10 and 12

• Percent Change From Baseline in the Total Cholesterol at Week 12

  Week 12

Study Arms (1)

Treatment group

EXPERIMENTAL

SHR-1209 administered by subcutaneous injection Atorvastatin or Rosuvastatin combined with Ezetimibe oral

Drug: SHR-1209

Interventions

SHR-1209 DRUG

SHR-1209 administered by subcutaneous injection Atorvastatin or Rosuvastatin combined with Ezetimibe oral

Treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ≥ 18 years of age
• Diagnosis of homozygous familial hypercholesterolemia
• Stable lipid-lowering therapies for at least 28 days
• LDL cholesterol ≥ 130 mg/dl (3.4 mmol/L)
• Triglyceride ≤ 400 mg/dL (4.5 mmol/L)
• Bodyweight of ≥ 40 kg at screening.

You may not qualify if:

• LDL or plasma apheresis within 8 weeks prior to randomization
• New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction \< 30%
• Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft or stroke within 3 months of randomization, Planned cardiac surgery or revascularization, Uncontrolled cardiac arrhythmia
• Liver transplant history.
• Uncontrolled hypertension.
• Moderate to severe renal dysfunction.
• Active liver disease or hepatic dysfunction.
• Known sensitivity to any of the products to be administered during dosing

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Related Publications (1)

• Shu C, Wang Y, Feng S, Yang S, Shen K. Population Pharmacokinetics and Pharmacodynamics Modeling for the Use of Recaticimab in Healthy Volunteers and Patients with Hypercholesterolemia. Clin Pharmacokinet. 2025 Sep;64(9):1341-1355. doi: 10.1007/s40262-025-01512-5. Epub 2025 Jun 30.

  PMID: 40587053 DERIVED

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

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

Bin Zhang, Medial Manager

CONTACT

+86 13671548369; zhangbin@hrglobe.cn

Bo Zhu, Medical Director

CONTACT

+86 13380043088; zhubo@hrglobe.cn

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: June 29, 2020
• First Posted: July 2, 2020
• Study Start: September 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: August 31, 2021
• Last Updated: July 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share