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

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

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

Study Overview

• Status: Completed
• Conditions: Primary Hypercholesterolemia; Mixed Hyperlipemia
• Intervention / Treatment: Drug: SHR-1209; Drug: SHR-1209 Placebo

• Study Type: Interventional
• Enrollment (Actual): 709
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangzhou
    • Guangzhou, Guangzhou, China, 510120
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-1209	Drug: SHR-1209; SHR-1209
Placebo Comparator: SHR-1209 Placebo	Drug: SHR-1209 Placebo; SHR-1209 Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
12-weeks or 16weeks Percentage change in LDL-C relative to baseline	12-weeks or 16weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
12-weeks or 16weeks change in LDL-C relative to baseline；	12-weeks or 16weeks
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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2021
• Primary Completion (Actual): June 21, 2022
• Study Completion (Actual): January 13, 2023

Study Registration Dates

• First Submitted: March 31, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Dyslipidemias; Lipid Metabolism, Inborn Errors; Hyperlipoproteinemias; Hypertriglyceridemia; Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemia Type V
• Other Study ID Numbers: SHR-1209-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No