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

NCT04844125 | Completed Phase 3

• 1 other identifier: SHR-1209-303
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Secondary Outcomes (2)

• 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

Study Arms (2)

SHR-1209

EXPERIMENTAL

Drug: SHR-1209

SHR-1209 Placebo

PLACEBO COMPARATOR

Drug: SHR-1209 Placebo

Interventions

SHR-1209 DRUG

SHR-1209

SHR-1209

SHR-1209 Placebo DRUG

SHR-1209 Placebo

SHR-1209 Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any male or female aged between 18 and 80 on the date of signing the informed consent;
• Diagnosed as hypercholesterolemia ;
• Fasting triglyceride was less than 5.6 mmol/L during screening:
• Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.

You may not qualify if:

• A history of the following diseases or treatments during the screening period:
• Known allergies to PCSK9 inhibitors or test drugs, or severe allergic reactions to other antibody drugs in the past;
• 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);
• Any of the laboratory test indicators meets the following criteria:
• 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;
• The creatine kinase (CK) was more than 3 times of ULN during the screening period or at random;
• Have used the following drugs:
• PCSK9 inhibitors had been used in the previous 6 months;
• Continuous systemic corticosteroid therapy with doses exceeding or equivalent to 10mg of prednisone (oral or intravenous) within the previous 3 months was screened.
• Other circumstances:
• 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
• Subjects who are considered by the investigator to have any unsuitable factors for participating in the study or who have poor compliance.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangzhou, 510080, China

Location

Related Publications (2)

• Li L, Zhou Y, Deng C, Sheng J, Peng D, Ling Z, Wang L, Dai C, Huang K, Lian Q, Yu Z, Yang H, Hu Y, Dong Y, Wang N, Wang Z, Zhang W, Han X, Yao Z, Liu Q, Liang Y, Xu B, Wang Y, Zhong T, Chen J. Recaticimab in adult heterozygous familial hypercholesterolaemia (REMAIN-3): a multicentre, randomized, double-blind, placebo-controlled Phase 3 study. Cardiovasc Res. 2025 Oct 24;121(12):1856-1864. doi: 10.1093/cvr/cvaf155.

  PMID: 40911402 DERIVED

• Shu C, Wang Y, Feng S, Yang S, Shen K. Population Pharmacokinetics and Pharmacodynamics Modeling for the Use of Recaticimab in Healthy Volunteers and Patients with Hypercholesterolemia. Clin Pharmacokinet. 2025 Sep;64(9):1341-1355. doi: 10.1007/s40262-025-01512-5. Epub 2025 Jun 30.

  PMID: 40587053 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Background Lipolowering therapy in combination with SHR-1209/ placebo

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 14, 2021
• Study Start: April 14, 2021
• Primary Completion: August 12, 2022
• Study Completion: August 12, 2022
• Last Updated: April 25, 2023

Record last verified: 2022-05

Locations

CN (1)