Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
Study NCT ID:
NCT07295418
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2025-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of SAL003 in Participants With Hypercholesterolemia and Mixed Dyslipidemia
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 618}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-07', 'studyFirstSubmitDate': '2025-12-07', 'studyFirstSubmitQcDate': '2025-12-07', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change of Low-Density Lipoprotein Cholesterol (LDL-C).', 'timeFrame': 'at Week 12', 'description': 'Percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low-density lipoprotein cholesterol', 'PCSK9', 'SAL003'], 'conditions': ['Hyperlipidemias']}, 'descriptionModule': {'briefSummary': 'This is a Phase 3 study to evaluate the efficacy and safety of SAL003, a fully human monoclonal antibody against PCSK9, as monotherapy in Chinese participants with hypercholesterolemia and mixed dyslipidemia. Participants who are not on lipid-lowering therapy or have washed out from previous therapy will be randomized in a 2:1 ratio to receive either SAL003 140 mg or matching placebo, administered subcutaneously every 4 weeks for 12 weeks. Following the double-blind period, all participants will enter an open-label extension period and receive SAL003 140 mg Q4W for an additional 40 weeks. The primary objective is to demonstrate the superiority of SAL003 over placebo in reducing Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12.', 'detailedDescription': 'This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical trial. The study consists of four periods: a Screening Period (up to 1 week), a Run-in Period (2 weeks), a Double-blind Treatment Period (12 weeks), and an Extended Treatment Period (40 weeks), with a total study duration of approximately 55 weeks per participant.\n\nApproximately 600 participants will be randomized. Eligible participants must be aged 18-75 years with a fasting LDL-C level between 2.6 mmol/L and 4.9 mmol/L, who are either statin-naïve or have washed out from lipid-lowering drugs for at least 3 months. Key exclusion criteria include familial hypercholesterolemia, established atherosclerotic cardiovascular disease (ASCVD), uncontrolled hypertension, poorly controlled diabetes, and significant hepatic or renal impairment.\n\nIn the Double-blind Period, participants will be stratified by baseline LDL-C (\\<3.4 mmol/L or ≥3.4 mmol/L) and randomized to receive either SAL003 140 mg or placebo via subcutaneous injection every 4 weeks for 3 doses (Days 1, 29, and 57). After completing the 12-week double-blind period, all participants will enter the Extended Treatment Period and receive open-label SAL003 140 mg Q4W for 10 additional doses (from Week 12 to Week 52).\n\nThe primary efficacy endpoint is the percent change from baseline in LDL-C at Week 12. Key secondary endpoints include the change from baseline in LDL-C at Week 12, the proportion of participants achieving LDL-C target goals at Week 12 and Week 52, and the percent change from baseline in other lipid parameters (e.g., TC, TG, Non-HDL-C, ApoB) at Week 12 and Week 52. Safety, immunogenicity, and pharmacokinetics will be assessed throughout the study.\n\nThe primary analysis will be performed on the Full Analysis Set (FAS) using a repeated measures mixed-effects model (MMRM) to compare the least-squares mean difference between the SAL003 and placebo groups at Week 12.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, aged 18 to 75 years (inclusive).\n* Fasting LDL-C ≥2.6 mmol/L and \\<4.9 mmol/L at screening/randomization.\n* Meets criteria based on the 2023 Chinese Lipid Management Guidelines (e.g., specific LDL-C levels with certain risk factors, or presence of diabetes).\n* Fasting triglycerides (TG) ≤5.6 mmol/L at screening/randomization.\n* Provides written informed consent.\n\nExclusion Criteria:\n\n* Diagnosis of familial hypercholesterolemia (HoFH or HeFH).\n* History of atherosclerotic cardiovascular disease (ASCVD).\n* Uncontrolled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg).\n* Type 1 diabetes or poorly controlled Type 2 diabetes (HbA1c \\>8.0%).\n* Significant hepatic or renal impairment.\n* Active liver disease or positive for HIV or Syphilis.\n* History of malignancy within 5 years prior to screening.\n* Use of any lipid-lowering drugs (statins, ezetimibe, etc.) or traditional Chinese medicines known to affect lipid metabolism within 3 months prior to screening.\n* Prior treatment with any PCSK9 inhibitor.\n* Known hypersensitivity to any component of the investigational product or history of severe allergy to antibody therapies.\n* Any other condition deemed by the investigator to be unsuitable for participation.'}, 'identificationModule': {'nctId': 'NCT07295418', 'briefTitle': 'A Study of SAL003 in Participants With Hypercholesterolemia and Mixed Dyslipidemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shenzhen Salubris Pharmaceuticals Co., Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Clinical Study to Evaluate the Safety and Efficacy of SAL003 Monotherapy in Participants With Hypercholesterolemia and Mixed Dyslipidemia', 'orgStudyIdInfo': {'id': 'SAL003A301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Group', 'description': 'Drug: SAL003 140 mg', 'interventionNames': ['Drug: SAL003 140 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Reference Group', 'description': 'Drug: Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SAL003 140 mg', 'type': 'DRUG', 'description': 'Double-blind treatment period: Administer SAL003 140mg subcutaneously once every 4 weeks for a total of 3 times. Collect efficacy and safety results after 12 weeks. Extended administration period: Administer SAL003 140mg subcutaneously once every 4 weeks and follow up until 52 weeks to collect efficacy and safety results.', 'armGroupLabels': ['Test Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Double-blind treatment period: Administer Placebo subcutaneously once every 4 weeks for a total of 3 times. Collect efficacy and safety results after 12 weeks. Extended administration period: Administer SAL003 140mg subcutaneously once every 4 weeks and follow up until 52 weeks to collect efficacy and safety results.', 'armGroupLabels': ['Reference Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100083', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenzhen Salubris Pharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Salubris (Chengdu) Biotechnology Co., Ltd.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}