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

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

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangzhou
    • Guangzhou, Guangzhou, China, 510080
      • Guangdong Provincial People's Hospital

Participation Criteria

Eligibility Criteria

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

Description

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.

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 Percentage change in serum LDL-C levels from baseline.	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
12 weeks Absolute Changes in serum LDL-C levels from baseline；	12 weeks
12 weeks Percentage change of non-HDL-C relative to baseline；	12 weeks

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2021
• Primary Completion (Actual): August 12, 2022
• Study Completion (Actual): August 12, 2022

Study Registration Dates

• First Submitted: April 2, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 14, 2021

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: SHR-1209-303

Drug and device information, study documents

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