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

• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04844125
• Collaborator: (none)
• Enrollment: 144
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19.5
• Patients Per Site Per Month: 7.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Primary Hypercholesterolemia	Drug: SHR-1209; Drug: SHR-1209 Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 144 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Background Lipolowering therapy in combination with SHR-1209/ placeboBackground Lipolowering therapy in combination with SHR-1209/ placebo
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 14, 2021
• Actual Primary Completion Date: Apr 19, 2022
• Anticipated Study Completion Date: Nov 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 12 weeks Percentage change in serum LDL-C levels from baseline. [12 weeks]

Secondary Outcome Measures

1. 12 weeks Absolute Changes in serum LDL-C levels from baseline； [12 weeks]

2. 12 weeks Percentage change of non-HDL-C relative to baseline； [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

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

3. 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);

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

5. 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;

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

7. Have used the following drugs:

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

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

10. Other circumstances:

11. 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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangdong Provincial People's Hospital	Guangzhou	Guangzhou	China	510080

Sponsors and Collaborators

• Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04844125
• Other Study ID Numbers: SHR-1209-303
• First Posted: Apr 14, 2021
• Last Update Posted: May 17, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypercholesterolemia

Study Results

No Results Posted as of May 17, 2022