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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-08-31

Brief Summary

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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 .

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Detailed Description

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Conditions

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Familial Hypercholesterolemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

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

Group Type EXPERIMENTAL

SHR-1209

Intervention Type DRUG

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

Interventions

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SHR-1209

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No