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

• Status: Not yet recruiting
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

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 .

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

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