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

Familial Hypercholesterolemia Clinical Trial

Official title:

Open-label, Single-arm, Multicentre Study to Evaluate Efficacy and Safety of SHR-1209 in Subjects With Homozygous Familial Hypercholesterolemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04455581
• Other study ID #: SHR-1209-201
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 1, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: June 2020
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Bin Zhang, Medial Manager
• Phone: +86 13671548369
• Email: zhangbin[@]hrglobe.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8
• Est. completion date: August 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change from Baseline in LDL-C at Week 12		Week 12
Secondary	Change From Baseline in LDL-C at Week 12		Week 12
Secondary	Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12		Weeks 10 and 12
Secondary	Change From Baseline in LDL-C at the Mean of Weeks 10 and 12		Weeks 10 and 12
Secondary	Percent Change From Baseline in the Total Cholesterol at the Mean of Weeks 10 and 12		Weeks 10 and 12
Secondary	Percent Change From Baseline in the Total Cholesterol at Week 12		Week 12
Secondary	Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12		Weeks 10 and 12
Secondary	Percent Change From Baseline in HDL-C at Week 12		Week 12
Secondary	Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12		Weeks 10 and 12
Secondary	Percent Change From Baseline in Non-HDL-C at Week 12		Week 12
Secondary	Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12		Weeks 10 and 12
Secondary	Percent Change From Baseline in Triglycerides at Week 12		Week 12
Secondary	Percent Change From Baseline in Apo B at the Mean of Weeks 10 and 12		Weeks 10 and 12
Secondary	Percent Change From Baseline in ApoB at Week 12		Week 12
Secondary	Percent Change From Baseline in Apo A1 at the Mean of Weeks 10 and 12		Weeks 10 and 12
Secondary	Percent Change From Baseline in Apo A1 at Week 12		Week 12
Secondary	Percent Change From Baseline in Lipo(a) at the Mean of Weeks 10 and 12		Weeks 10 and 12
Secondary	Percent Change From Baseline in Lipo(a) at Week 12		Week 12
Secondary	Number of investigational product-related adverse events		Weeks 12 and 20
Secondary	Number of ADA and Nab		Week 20