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

Primary Purpose

Familial Hypercholesterolemia

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

SHR-1209

About this trial

This is an interventional treatment trial for Familial Hypercholesterolemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

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

Outcomes

Primary Outcome Measures

Percent Change from Baseline in LDL-C at Week 12

Secondary Outcome Measures

Change From Baseline in LDL-C at Week 12

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

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

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

Percent Change From Baseline in the Total Cholesterol at Week 12

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

Percent Change From Baseline in HDL-C at Week 12

Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12

Percent Change From Baseline in Non-HDL-C at Week 12

Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12

Percent Change From Baseline in Triglycerides at Week 12

Percent Change From Baseline in Apo B at the Mean of Weeks 10 and 12

Percent Change From Baseline in ApoB at Week 12

Percent Change From Baseline in Apo A1 at the Mean of Weeks 10 and 12

Percent Change From Baseline in Apo A1 at Week 12

Percent Change From Baseline in Lipo(a) at the Mean of Weeks 10 and 12

Percent Change From Baseline in Lipo(a) at Week 12

Number of investigational product-related adverse events

Number of ADA and Nab

Full Information

NCT ID

NCT04455581

First Posted

June 29, 2020

Last Updated

June 29, 2020

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04455581

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2020 (Anticipated)

Primary Completion Date

June 30, 2021 (Anticipated)

Study Completion Date

August 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Familial Hypercholesterolemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

SHR-1209

Intervention Description

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

Primary Outcome Measure Information:

Title

Percent Change from Baseline in LDL-C at Week 12

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Change From Baseline in LDL-C at Week 12

Time Frame

Week 12

Title

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

Time Frame

Weeks 10 and 12

Title

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

Time Frame

Weeks 10 and 12

Title

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

Time Frame

Weeks 10 and 12

Title

Percent Change From Baseline in the Total Cholesterol at Week 12

Time Frame

Week 12

Title

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

Time Frame

Weeks 10 and 12

Title

Percent Change From Baseline in HDL-C at Week 12

Time Frame

Week 12

Title

Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12

Time Frame

Weeks 10 and 12

Title

Percent Change From Baseline in Non-HDL-C at Week 12

Time Frame

Week 12

Title

Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12

Time Frame

Weeks 10 and 12

Title

Percent Change From Baseline in Triglycerides at Week 12

Time Frame

Week 12

Title

Percent Change From Baseline in Apo B at the Mean of Weeks 10 and 12

Time Frame

Weeks 10 and 12

Title

Percent Change From Baseline in ApoB at Week 12

Time Frame

Week 12

Title

Percent Change From Baseline in Apo A1 at the Mean of Weeks 10 and 12

Time Frame

Weeks 10 and 12

Title

Percent Change From Baseline in Apo A1 at Week 12

Time Frame

Week 12

Title

Percent Change From Baseline in Lipo(a) at the Mean of Weeks 10 and 12

Time Frame

Weeks 10 and 12

Title

Percent Change From Baseline in Lipo(a) at Week 12

Time Frame

Week 12

Title

Number of investigational product-related adverse events

Time Frame

Weeks 12 and 20

Title

Number of ADA and Nab

Time Frame

Week 20

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bin Zhang, Medial Manager

Phone

+86 13671548369

zhangbin@hrglobe.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Bo Zhu, Medical Director

Phone

+86 13380043088

zhubo@hrglobe.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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