Study of SHR-1209 in the Treatment of Hypercholesterolemia and Hyperlipidemia Ⅲ Stage

Primary Hypercholesterolemia Clinical Trial

Official title:

Phase III, Multicentre, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of SHR-1209 Monotherapy in Patients With Primary Hypercholesterolemia and Mixed Hyperlipemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04849000
• Other study ID #: SHR-1209-301
• Status: Completed
• Phase: Phase 3
• Start date: April 23, 2021
• Est. completion date: January 13, 2023

Study information

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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 709
• Est. completion date: January 13, 2023
• Est. primary completion date: June 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age =18 and =80 on the date of signing the informed consent, male or female;

2. Fasting LDL-C was =2.6mmol/L and <4.9mmol/L at screening and randomization;

3. Those who understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent in person.

Exclusion Criteria:

1. Have the following diseases or treatment history :(1) Have known allergic reaction to experimental drugs, or have severe allergic reaction to other antibody drugs;(2) previous diagnosis of cardiac function as defined by the New York Heart Association (NYHA) grade III-IV;

2. Any of the laboratory indicators met the following criteria at screening or at random :(1) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 2 times the upper limit of normal (ULN), or total bilirubin exceeding 1.5 times the upper limit of normal (ULN);(2) Creatine kinase (CK) exceeds 3 times the upper limit of normal value (ULN);

3. General conditions :(1) the investigator judged that subcutaneous injection was not appropriate;(2) Fertile female subjects who did not use contraception within 4 weeks before screening;Or male or female subjects who do not agree to use high-efficiency contraceptives during the trial and for 24 weeks after the last dosing;(3) Women who are pregnant or lactating.

4. The Investigator determines that the subjects have poor compliance or have any factors that may prevent them from participating in the study, including, but not limited to, the study placing the subjects at unacceptable risk or possibly interfering with the study results.

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hyperlipidemias
• Hyperlipoproteinemia Type V
• Mixed Hyperlipemia
• Primary Hypercholesterolemia

Intervention

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

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	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 or 16weeks Percentage change in LDL-C relative to baseline		12-weeks or 16weeks
Secondary	12-weeks or 16weeks change in LDL-C relative to baseline;		12-weeks or 16weeks
Secondary	Percentage of changes in non-HDL-C, ApoB, TC/HDL-C, ApoB/ApoA1, LP (a) and TG relative to baseline and relative to baseline after 12 weeks or 16 weeks of treatment		12 weeks or 16 weeks