Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-04-14 @ 3:39 PM
Study NCT ID:
NCT06471218
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-10
First Post:
2024-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-08', 'studyFirstSubmitDate': '2024-06-18', 'studyFirstSubmitQcDate': '2024-06-18', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change in calculated LDL-C from baseline to week 24', 'timeFrame': 'from baseline to week 24'}], 'secondaryOutcomes': [{'measure': 'Percent change in calculated TG from baseline to week 24', 'timeFrame': 'from baseline to week 24'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperlipidemia']}, 'descriptionModule': {'briefSummary': 'Evaluation of the efficacy and safety of multiple subcutaneous injections of SHR-1918 in patients with hyperlipidemia in poor control: a multicenter, randomized, double-blind, placebo-controlled phase II clinical trials'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. On the day of signing the informed consent form, the age must be ≥ 18 years old and ≤ 75 years old, both men and women are eligible;\n2. Screen spatiotemporal abdominal LDL-C for ASCVD risk assessment, meeting the following conditions:\n3. TG≤5.6mmol/L；\n\nExclusion Criteria:\n\n1. (1) Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma glutamyltransferase (GGT) exceeding 3 times the ULN, or total bilirubin exceeding 2 times the ULN;\n2. (2) Human immunodeficiency virus antibody (HIV Ab), hepatitis C virus antibody (HCV Ab), any of the above test results are positive; Hepatitis B virus surface antigen (HBsAg) positive and HBV-DNA ≥ 1000 copies/ml (or ≥ 200IU/ml, if the lower limit of the detection value is higher than 1000 copies/ml or 200IU/ml, HBV-DNA ≥ the lower limit of the detection value);\n3. (3) Creatine kinase (CK) exceeds 3 times the upper limit of normal value (ULN);\n4. (4) Thyroid stimulating hormone (TSH) is below the lower limit of normal (LLN) or exceeds 1.5 times the upper limit of normal (ULN);\n5. (5) Glomerular filtration rate (eGFR)\\<30 ml/min/1.73m2 (calculated using the MDRD formula, eGFR (mL/min/1.73m2)=175 x (serum creatinine/88.4) -1.234 x age -0.179 x (0.79 females), where serum creatinine units are μ mol/L);'}, 'identificationModule': {'nctId': 'NCT06471218', 'briefTitle': 'Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beijing Suncadia Pharmaceuticals Co., Ltd'}, 'officialTitle': 'Evaluation of the Efficacy and Safety of Multiple Subcutaneous Injections of SHR-1918 in Patients With Hyperlipidemia in Poor Control: a Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trials', 'orgStudyIdInfo': {'id': 'SHR-1918-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A:SHR-1918/SHR-1918 Placebo', 'interventionNames': ['Drug: SHR-1918; SHR-1918 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B:SHR-1918/SHR-1918 Placebo', 'interventionNames': ['Drug: SHR-1918; SHR-1918 Placebo']}], 'interventions': [{'name': 'SHR-1918; SHR-1918 Placebo', 'type': 'DRUG', 'description': 'SHR-1918/SHR-1918 Placebo,two administration', 'armGroupLabels': ['Treatment A:SHR-1918/SHR-1918 Placebo', 'Treatment B:SHR-1918/SHR-1918 Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '514031', 'city': 'Meizhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Meizhou People's Hospital", 'geoPoint': {'lat': 24.28859, 'lon': 116.11768}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Suncadia Pharmaceuticals Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}