Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:04 AM
Study NCT ID:
NCT07477704
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-17
First Post:
2026-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571059', 'term': 'alirocumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 420}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-14', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-03-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2026-03-12', 'studyFirstSubmitQcDate': '2026-03-12', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change in LDL-C', 'timeFrame': 'From Baseline through Week 12'}], 'secondaryOutcomes': [{'measure': 'Number of participants meeting up-titration of dose of alirocumab', 'timeFrame': 'Week 12 through Week 24'}, {'measure': 'Concentrations of total alirocumab in serum', 'timeFrame': 'Through Week 32'}, {'measure': 'Concentrations of free Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) in serum', 'timeFrame': 'Through Week 32'}, {'measure': 'Percent change in LDL-C', 'timeFrame': 'From Baseline through Week 24'}, {'measure': 'Percent change in total cholesterol', 'timeFrame': 'From Baseline through Week 24'}, {'measure': 'Percent change in non-High-Density Lipoprotein-Cholesterol (HDL-C)', 'timeFrame': 'From Baseline through Week 24'}, {'measure': 'Percent change in HDL-C', 'timeFrame': 'From Baseline through Week 24'}, {'measure': 'Percent change in triglycerides', 'timeFrame': 'From Baseline through Week 24'}, {'measure': 'Percent change in Apolipoprotein B (ApoB)', 'timeFrame': 'From Baseline through Week 24'}, {'measure': 'Occurrence of Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'Through Week 32'}, {'measure': 'Severity of TEAEs', 'timeFrame': 'Through Week 32'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Elevated Low-Density Lipoprotein Cholesterol (LDL-C) Levels'], 'conditions': ['Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'This study is researching an experimental drug called alirocumab, referred to as "study drug". In the United States, alirocumab is approved for the treatment of hypercholesterolemia (high blood cholesterol levels).\n\nThe aim of the study is to see how safe and effective alirocumab is when given weekly to adult participants who have hypercholesterolemia.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug once a week\n* How much study drug is in the blood at different times'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1\\. Participant has elevated LDL-C level, as defined in the protocol\n\nKey Exclusion Criteria:\n\n1. Participant plans to initiate or change dose of lipid-lowering therapy\n2. Use of any PCSK9 inhibitors\n3. Participant has Type 1 diabetes\n\nNOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply'}, 'identificationModule': {'nctId': 'NCT07477704', 'briefTitle': 'A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A Randomized, Open-Label, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Weekly Alirocumab in Adults With Hypercholesterolemia', 'orgStudyIdInfo': {'id': 'R727-CL-2553'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 - Low Dose', 'interventionNames': ['Drug: Alirocumab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2 - Medium Dose', 'interventionNames': ['Drug: Alirocumab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3 - High Dose', 'interventionNames': ['Drug: Alirocumab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4 - Higher Dose', 'interventionNames': ['Drug: Alirocumab']}], 'interventions': [{'name': 'Alirocumab', 'type': 'DRUG', 'otherNames': ['Praluent®', 'REGN727', 'SAR236553'], 'description': 'Administered per the protocol', 'armGroupLabels': ['Arm 1 - Low Dose', 'Arm 2 - Medium Dose', 'Arm 3 - High Dose', 'Arm 4 - Higher Dose']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Clinical Trials Administrator', 'role': 'CONTACT', 'email': 'clinicaltrials@regeneron.com', 'phone': '844-734-6643'}], 'overallOfficials': [{'name': 'Clinical Trial Management', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regeneron Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'When Regeneron has:\n\n* received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development\n* made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)\n* the legal authority to share the data, and\n* ensured the ability to protect participant privacy', 'ipdSharing': 'YES', 'description': 'All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.', 'accessCriteria': "Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}