SHR - 1209 Treatment Efficacy and Safety of the Patients With Hypercholesterolemia Ⅲ Period Clinical Research

Primary Hypercholesterolemia Clinical Trial

Official title:

A Multicentric, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of SHR-1209 in Patients With Hypercholesterolemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04844125
• Other study ID #: SHR-1209-303
• Status: Completed
• Phase: Phase 3
• Start date: April 14, 2021
• Est. completion date: August 12, 2022

Study information

• Verified date: May 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is ongoing to evaluate the efficacy and safety of SHR-1209 in patients with hypercholesterolemia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: August 12, 2022
• Est. primary completion date: August 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Any male or female aged between 18 and 80 on the date of signing the informed consent;

2. Diagnosed as hypercholesterolemia ;

3. Fasting triglyceride was less than 5.6 mmol/L during screening:

4. Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.

Exclusion Criteria:

1. A history of the following diseases or treatments during the screening period:

1. Known allergies to PCSK9 inhibitors or test drugs, or severe allergic reactions to other antibody drugs in the past;

2. Participated in clinical studies of other drug interventions within the last 1 month (except for patients who failed in screening), or those who are within 5 half-lives of the drug before screening (whichever is longer);

2. Any of the laboratory test indicators meets the following criteria:

1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) was more than 3 times the upper limit of normal value (ULN), and total bilirubin was more than 2 times ULN during the screening period or at random;

2. The creatine kinase (CK) was more than 3 times of ULN during the screening period or at random;

3. Have used the following drugs:

1. PCSK9 inhibitors had been used in the previous 6 months;

2. Continuous systemic corticosteroid therapy with doses exceeding or equivalent to 10mg of prednisone (oral or intravenous) within the previous 3 months was screened.

4. Other circumstances:

1. Women of reproductive age who are fertile but did not use contraception within 4 weeks before the screening period;Women who are pregnant or breastfeeding;Not agreed during the trial or at 24 weeks after the last dose

2. Subjects who are considered by the investigator to have any unsuitable factors for participating in the study or who have poor compliance.

Related Conditions & MeSH terms

• Hypercholesterolemia
• Primary Hypercholesterolemia

Intervention

Drug:
• SHR-1209
SHR-1209
• SHR-1209 Placebo
SHR-1209 Placebo

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12 weeks Percentage change in serum LDL-C levels from baseline.		12 weeks
Secondary	12 weeks Absolute Changes in serum LDL-C levels from baseline;		12 weeks
Secondary	12 weeks Percentage change of non-HDL-C relative to baseline;		12 weeks