Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-01-11 @ 11:54 AM
Study NCT ID:
NCT04885218
Status:
COMPLETED
Last Update Posted:
2024-01-31
First Post:
2021-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of SHR-1209 Combined With Lipid-lowering Agents in Patients With Hypercholesterolemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}], 'ancestors': [{'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'SHR-1209 combined with lipid-lowering agents'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 692}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-29', 'studyFirstSubmitDate': '2021-04-30', 'studyFirstSubmitQcDate': '2021-05-07', 'lastUpdatePostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage change in LDL-C relative to baseline', 'timeFrame': 'at 24 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'The value of change in LDL-C relative to baseline', 'timeFrame': 'at 24 weeks of treatment'}, {'measure': 'Percentage change in LDL-C relative to baseline', 'timeFrame': 'at 48 weeks of treatment;'}, {'measure': 'The value of change in LDL-C relative to baseline ,', 'timeFrame': 'at 48 weeks of treatment;'}, {'measure': 'Percentage change in non-HDL-C relative to baseline', 'timeFrame': 'at 24 weeks of treatment;'}, {'measure': 'Percentage change in non-HDL-C relative to baseline', 'timeFrame': 'at 48 weeks of treatment;'}, {'measure': 'Percentage change in ApoB relative to baseline', 'timeFrame': 'at 24 weeks of treatment;'}, {'measure': 'Percentage change in ApoB relative to baseline', 'timeFrame': 'at 48 weeks of treatment;'}, {'measure': 'Percentage change in TC/HDL-C relative to baseline', 'timeFrame': 'at 24 weeks of treatment;'}, {'measure': 'Percentage change in TC/HDL-C relative to baseline,', 'timeFrame': 'at 48 weeks of treatment'}, {'measure': 'Percentage change in ApoB/ApoA1 relative to baseline,', 'timeFrame': 'at 24 weeks of treatment;'}, {'measure': 'Percentage change in ApoB/ApoA1 relative to baseline,', 'timeFrame': 'at 48 weeks of treatment;'}, {'measure': 'Percentage change in LP (a) relative to baseline,', 'timeFrame': 'at 24 weeks of treatment;'}, {'measure': 'Percentage change in LP (a) relative to baseline,', 'timeFrame': 'at 48 weeks of treatment;'}, {'measure': 'Percentage change in TG relative to baseline', 'timeFrame': 'at 24 weeks of treatment'}, {'measure': 'Percentage change in TG relative to baseline', 'timeFrame': 'at 48 weeks of treatment;'}, {'measure': 'Percentage of patients who achieved LDL-C goal according to presence of ASCVD at baseline,', 'timeFrame': 'at 48 weeks of treatment;'}, {'measure': 'Percentage of patients who achieved LDL-C goal according to presence of ASCVD at baseline,', 'timeFrame': 'at 48 weeks of treatment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-familial Hypercholesterolemia', 'Mixed Hyperlipidemia']}, 'referencesModule': {'references': [{'pmid': '40587053', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SHR-1209 subcutaneous administration in patients with non-familial hypercholesterolemia and mixed hyperlipidemia after lipid-lowering therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 and ≤80 on the date of signing the informed consent, male or female;\n2. The report of LDL-C should be higher than the ideal lipid-lowering target according to ASCVD history;\n3. Fasting triglycerides less than equal to 5.6 mmol/L；\n4. Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.\n\nExclusion Criteria:\n\n1. 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 familial hypercholesterolemia according to Simon Broome Criteria;(3) cardiac function as defined by the New York Heart Association (NYHA) grade III-IV at screening or randomization or latest detected LVEF\\<30%;(4) CVD events within 3 months; (5) uncontrolled hypertension; (6) prior exposure to recaticimab or other PCSK9 inhibitors; (7) inadequate organ functions.\n2. Any of the laboratory indicators met the following criteria at screening or at randomization :(1) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 3 times the upper limit of normal (ULN), or total bilirubin exceeding 2 times the upper limit of normal (ULN);(2) Creatine kinase (CK) exceeds 3 times the upper limit of normal value (ULN);\n3. 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.\n4. 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.'}, 'identificationModule': {'nctId': 'NCT04885218', 'briefTitle': 'Efficacy and Safety of SHR-1209 Combined With Lipid-lowering Agents in Patients With Hypercholesterolemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Multicentre, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of SHR-1209 Combined With Lipid-lowering Agents in the Stable Treatment of Patients With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia .', 'orgStudyIdInfo': {'id': 'SHR-1209-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1：SHR-1209 / placebo', 'interventionNames': ['Drug: SHR-1209 ;placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2：SHR-1209 /placebo', 'interventionNames': ['Drug: SHR-1209 ;placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3：SHR-1209 / placebo', 'interventionNames': ['Drug: SHR-1209 ;placebo']}], 'interventions': [{'name': 'SHR-1209 ;placebo', 'type': 'DRUG', 'description': 'SHR-1209 and placebo 150 mg subcutaneous injection once every 4 weeks for 48 weeks', 'armGroupLabels': ['Cohort 1：SHR-1209 / placebo']}, {'name': 'SHR-1209 ;placebo', 'type': 'DRUG', 'description': 'SHR-1209 and placebo 300 mg subcutaneous injection once every 8 weeks for 48 weeks', 'armGroupLabels': ['Cohort 2：SHR-1209 /placebo']}, {'name': 'SHR-1209 ;placebo', 'type': 'DRUG', 'description': 'SHR-1209 and placebo 450 mg subcutaneous injection once every 12 weeks for 48 weeks', 'armGroupLabels': ['Cohort 3：SHR-1209 / placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Anzhen hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}