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The Safety, Tolerability and Efficacy of Multiple Subcutaneous Injections of SHR-1209 in Subjects With Hyperlipidemia

Primary Purpose

Hyperlipidemia

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

SHR-1209

Placebo

About this trial

This is an interventional treatment trial for Hyperlipidemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥18 and ≤65 years old;
Subjects who are receiving statin therapy at the time of screening or who are eligible for statin therapy can randomized to receive a stable dose of statin therapy for more than 28 days and are willing to maintain stable statin therapy in this study;
Low-density lipoprotein cholesterol (LDL-C) level ≥2.6mmol/L of subjects who receiving statin and/or other lipid-lowering therapy at the time of screening, or LDL-C≥ 3.4mmol/L of subjects who didn't receive any-lowering therapy at the time of screening, and LDL-C still ≥2.6mmol/L before randomization;
Fasting triglycerides ≤4.5 mmol/L;
Body mass index (BMI) ≥18 and ≤ 35 kg/m2;
Signed informed consent.

Exclusion Criteria:

A clinical history of drug allergy or a history of atopic allergic diseases (asthma, urticaria, eczema dermatitis) or a known allergy to experimental or similar experimental drugs;
Diagnosis of homozygous familial hypercholesterolemia;
New York heart association (NYHA) defined Ⅱ - Ⅳ history of heart failure;
History of acute coronary syndrome (e.g. myocardial infarction, hospitalization for unstable angina), or percutaneous coronary intervention, or coronary artery bypass graft, or history of cerebrovascular disease, within 12 months prior to screening;
Uncontrolled severe arrhythmias that are not controlled by drugs or other therapy within 12 months prior to enrollment;
Uncontrolled hypertension (systolic blood pressure ≥ 160 and/or diastolic blood pressure ≥ 100 mmHg);
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma pancreatic acyl transferase (GGT), more than 2.5x ULN;
Subjects with previous malignant tumor diseases. etc.

Sites / Locations

Sun Yat-Sen Memorial Hospital ,The Second Affiliated Hospital of Sun Yat-Sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SHR-1209

Placebo

Arm Description

Participants received one of 6 dose levels of SHR-1209 administered as multiple subcutaneous doses.

Participants received matching placebo dose regimens by subcutaneous injection.

Outcomes

Primary Outcome Measures

Primary efficacy end point:Percent change from baseline to end of the dosing interval in LDL-C.

Primary safety end point:Number of subjects with adverse events.

Secondary Outcome Measures

Absolute change from baseline to end of the dosing interval in LDL-C.

Percent change from baseline to day 85 in LDL-C.

Absolute change from baseline to day 85 in LDL-C.

Percent change in PCSK9.

Absolute change in PCSK9.

Full Information

NCT ID

NCT03944109

First Posted

May 4, 2019

Last Updated

November 29, 2022

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03944109

Brief Title

The Safety, Tolerability and Efficacy of Multiple Subcutaneous Injections of SHR-1209 in Subjects With Hyperlipidemia

Official Title

The Safety, Tolerability and Efficacy of Multiple Subcutaneous Injections of SHR-1209 in Subjects With Hyperlipidemia - A PhaseⅠb/Ⅱ Randomized, Double-Blind, Placebo-Controlled Clinical Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

June 20, 2019 (Actual)

Primary Completion Date

December 22, 2020 (Actual)

Study Completion Date

December 22, 2020 (Actual)

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

This is a randomized, double-blind, placebo- controlled phaseⅠb/Ⅱclinical study. Totally 108 subjects are planned to enrolled with 36 subjects in three low-dose groups (group 1, group 2 and group 3) and 72 subjects in three high-dose groups (group 4, group 5, and group 6).12 subjects with hyperlipidemia who received statin stable treatment for more than 28 days are enrolled in each low-dose group, randomly given SHR-1209 or placebo treatment at a ratio of 5:1. 24 subjects with hyperlipidemia who received statin stable treatment for more than 28 days are enrolled in each high-dose group, randomly given SHR-1209 or placebo treatment at a ratio of 5:1. The primary objective of this study is to evaluate the safety, tolerability, and efficacy of multiple subcutaneous injections of SHR-1209 in hyperlipidemia subjects treated with stabilized dose of statin. Groups detail as follows: SHR-1209 dose 1 /placebo frequence 1 SHR-1209 dose 2 /placebo frequence 2 SHR-1209 dose 3 /placebo frequence 3 SHR-1209 dose 4 /placebo frequence 1 SHR-1209 dose 5 /placebo frequence 2 SHR-1209 dose 6 /placebo frequence 3

6. Conditions and Keywords

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

Hyperlipidemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SHR-1209

Arm Type

Experimental

Arm Description

Participants received one of 6 dose levels of SHR-1209 administered as multiple subcutaneous doses.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants received matching placebo dose regimens by subcutaneous injection.

Intervention Type

Drug

Intervention Name(s)

SHR-1209

Intervention Description

Pharmaceutical form: lyophilized formulation Route of administration: subcutaneous

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Pharmaceutical form: lyophilized formulation Route of administration: subcutaneous

Primary Outcome Measure Information:

Title

Primary efficacy end point:Percent change from baseline to end of the dosing interval in LDL-C.

Time Frame

Baseline to day 113 for group1,2,4,5 or day 169 for group 3,6

Title

Primary safety end point:Number of subjects with adverse events.

Time Frame

Baseline to day 169 for group 1,3,4,6 or day 141 for group 2,5

Secondary Outcome Measure Information:

Title

Absolute change from baseline to end of the dosing interval in LDL-C.

Time Frame

Baseline to day 113 for group1,2,4,5 or day 169 for group 3,6

Title

Percent change from baseline to day 85 in LDL-C.

Time Frame

Baseline to day 85 for all 6 groups

Title

Absolute change from baseline to day 85 in LDL-C.

Time Frame

Baseline to day 85 for all 6 groups

Title

Percent change in PCSK9.

Time Frame

Baseline to day 169 for group 1,3,4,6 or day 141 for group 2,5

Title

Absolute change in PCSK9.

Time Frame

Baseline to day 169 for group 1,3,4,6 or day 141 for group 2,5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥18 and ≤65 years old; Subjects who are receiving statin therapy at the time of screening or who are eligible for statin therapy can randomized to receive a stable dose of statin therapy for more than 28 days and are willing to maintain stable statin therapy in this study; Low-density lipoprotein cholesterol (LDL-C) level ≥2.6mmol/L of subjects who receiving statin and/or other lipid-lowering therapy at the time of screening, or LDL-C≥ 3.4mmol/L of subjects who didn't receive any-lowering therapy at the time of screening, and LDL-C still ≥2.6mmol/L before randomization; Fasting triglycerides ≤4.5 mmol/L; Body mass index (BMI) ≥18 and ≤ 35 kg/m2; Signed informed consent. Exclusion Criteria: A clinical history of drug allergy or a history of atopic allergic diseases (asthma, urticaria, eczema dermatitis) or a known allergy to experimental or similar experimental drugs; Diagnosis of homozygous familial hypercholesterolemia; New York heart association (NYHA) defined Ⅱ - Ⅳ history of heart failure; History of acute coronary syndrome (e.g. myocardial infarction, hospitalization for unstable angina), or percutaneous coronary intervention, or coronary artery bypass graft, or history of cerebrovascular disease, within 12 months prior to screening; Uncontrolled severe arrhythmias that are not controlled by drugs or other therapy within 12 months prior to enrollment; Uncontrolled hypertension (systolic blood pressure ≥ 160 and/or diastolic blood pressure ≥ 100 mmHg); Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma pancreatic acyl transferase (GGT), more than 2.5x ULN; Subjects with previous malignant tumor diseases. etc.

Facility Information:

Facility Name

Sun Yat-Sen Memorial Hospital ,The Second Affiliated Hospital of Sun Yat-Sen University

City

Guangzhou

State/Province

Guangdong

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

35039035

Citation

Xu M, Zhu X, Wu J, Zhang Y, Zhao D, Wang X, Ding Y, Cao Y, Li C, Hu W, Sheng J, Luo Z, Zheng Z, Hu J, Liu J, Zhou X, Shen A, Ding X, Zhang Y, Zhao Y, Li Y, Zhong S, An S, Zou J, Yan L. PCSK9 inhibitor recaticimab for hypercholesterolemia on stable statin dose: a randomized, double-blind, placebo-controlled phase 1b/2 study. BMC Med. 2022 Jan 18;20(1):13. doi: 10.1186/s12916-021-02208-w.

Results Reference

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The Safety, Tolerability and Efficacy of Multiple Subcutaneous Injections of SHR-1209 in Subjects With Hyperlipidemia

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