Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT07219602
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-11
First Post:
2025-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effect of Obicetrapib/Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and/or Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069438', 'term': 'Ezetimibe'}], 'ancestors': [{'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This protocol includes a 12-week, 3-arm, placebo-controlled, double-blind treatment section, followed by a 40-week open-label extension period. All patients receive the FDC of obicetrapib 10mg and ezetimibe 10 mg, regardless of the intervention received in the double-blind treatment section of this trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-10-20', 'studyFirstSubmitQcDate': '2025-10-20', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percent change from Baseline over time in LDL-C', 'timeFrame': '40 weeks', 'description': 'The percent change from Baseline at every visit for LDL-C'}, {'measure': 'Proportion of participants that achieve LDL-C <100 mg/dL (<2.6 mmol/L), LDL-C <70 mg/dL (<1.8 mmol/L), and LDL-C <55 mg/dL (<1.4 mmol/L)', 'timeFrame': '40 weeks', 'description': 'The percent change from Baseline at every visit in the proportion of participants that achieve LDL-C \\<100 mg/dL (\\<2.6 mmol/L), LDL-C \\<70 mg/dL (\\<1.8 mmol/L), and LDL-C \\<55 mg/dL (\\<1.4 mmol/L)'}, {'measure': 'Percent change from Baseline over time in non-HDL-C', 'timeFrame': '40 weeks', 'description': 'The percent change from Baseline at every visit for non-HDL-C'}, {'measure': 'Percent change from Baseline over time in ApoB', 'timeFrame': '40 weeks', 'description': 'The percent change from Baseline at every visit in ApoB'}, {'measure': 'Percent change from Baseline over time in total cholesterol', 'timeFrame': '40 weeks', 'description': 'The percent change from Baseline at every visit for total cholesterol'}, {'measure': 'Percent change from Baseline over time in triglycerides', 'timeFrame': '40 weeks', 'description': 'The percent change from baseline at every visit for triglycerides'}, {'measure': 'Percent change from Baseline over time in HDL-C', 'timeFrame': '40 weeks', 'description': 'the percent change from Baseline at every visit for HDL-C'}, {'measure': 'Percent change from Baseline over time in Lp(a)', 'timeFrame': '40 weeks', 'description': 'the percent change from Baseline at every visit for Lp(a)'}], 'primaryOutcomes': [{'measure': 'The percent change from Baseline to Day 84 in LDL-C compared with placebo for the following treatment groups: - obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group; and - obicetrapib 10 mg monotherapy treatment group', 'timeFrame': '84 days'}], 'secondaryOutcomes': [{'measure': 'Percent change from Baseline to Day 84 in non-HDL-C for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group', 'timeFrame': 'Day 84'}, {'measure': 'Percent change from Baseline to Day 84 in HDL-C for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group', 'timeFrame': '84 days'}, {'measure': 'Percent change from Baseline to Day 84 in ApoB for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group', 'timeFrame': '84 days'}, {'measure': 'Percent change from Baseline to Day 84 in ApoA1 for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group', 'timeFrame': '84 days'}, {'measure': 'Percent change from Baseline to Day 84 in non-HDL-C for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group;', 'timeFrame': '84 days'}, {'measure': 'Percent change from Baseline to Day 84 in HDL-C for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group', 'timeFrame': 'Day 84'}, {'measure': 'Percent change from Baseline to Day 84 in ApoB for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group', 'timeFrame': 'Day 84'}, {'measure': 'Percent change from Baseline to Day 84 in ApoA1 for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group', 'timeFrame': 'Day 84'}, {'measure': 'Percent change from Baseline to Day 84 in lipoprotein (a) (Lp[a]) for the obicetrapib 10 mg + ezetimibe 10 mg FDC treatment group compared with the placebo group', 'timeFrame': 'Day 84'}, {'measure': 'Percent change from Baseline to Day 84 in Lp(a) for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group', 'timeFrame': 'Day 84'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lipidemia', 'Type 2 Diabetes (T2DM)', 'Metabolic Syndrome (MetS)']}, 'descriptionModule': {'briefSummary': 'This study will be a placebo-controlled, double-blind, randomized, Phase 3 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both as a fixed-dose combination (FDC) with ezetimibe 10 mg and as monotherapy, on top of guideline-recommended lipid-lowering therapy in patients with metabolic syndrome and/or Type 2 Diabetes Mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* fasting serum LDL-C ≥ 70 mg/dL (≥1.81 mmol/L)\n* Have fasting TG ≥150 mg/dL (≥1.7 mmol/L) and \\<400 mg/dL (\\<4.5 mmol/L)\n* Know diagnosis of T2DM OR have metabolic syndrome defined as fasting TG ≥150 mg/dL (≥1.7mmol/L) and \\<400 mg/dL (\\<4.5 mmol/L) and at least 2 risk factors\n* Are on stable guideline-recommended lipid-lowering therapy\n* Estimated glomerular filtration rate ≥15 mL/min/1.73 m2\n\nExclusion Criteria:\n\n* Have current or any previous history of New York Heart Association class III or IV heart failure or left ventricular ejection fraction \\<30%\n* Have been hospitalized for heart failure within 5 years prior to Screening\n* Have uncontrolled severe hypertension\n* Have a formal diagnosis of homozygous familial hypercholesterolemia\n* HbA1c ≥10.0% (≥0.100 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening\n* active liver disease'}, 'identificationModule': {'nctId': 'NCT07219602', 'acronym': 'RUBENS', 'briefTitle': 'A Study to Evaluate the Effect of Obicetrapib/Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and/or Metabolic Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'NewAmsterdam Pharma'}, 'officialTitle': 'A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of Obicetrapib 10 mg and Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and/or Metabolic Syndrome (RUBENS Trial)', 'orgStudyIdInfo': {'id': 'OBEZ-303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Obicetrapib/Ezetimibe', 'description': 'obicetrapib 10 mg + ezetimibe 10 mg FDC daily', 'interventionNames': ['Drug: obicetrapib 10 mg + ezetimibe 10 mg FDC daily']}, {'type': 'EXPERIMENTAL', 'label': 'Obicetrapib', 'description': 'obicetrapib 10 mg daily', 'interventionNames': ['Drug: Obicetrapib 10 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo on top of guideline-recommended lipid-lowering therapy', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Open-Label Extension', 'description': 'Open-Label Extension (OLE) with the FDC of Obicetrapib 10 mg and Ezetimibe 10 mg', 'interventionNames': ['Drug: obicetrapib 10 mg + ezetimibe 10 mg FDC daily']}], 'interventions': [{'name': 'obicetrapib 10 mg + ezetimibe 10 mg FDC daily', 'type': 'DRUG', 'description': 'FDC', 'armGroupLabels': ['Obicetrapib/Ezetimibe', 'Open-Label Extension']}, {'name': 'Obicetrapib 10 mg', 'type': 'DRUG', 'description': 'monotherapy', 'armGroupLabels': ['Obicetrapib']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'placebo on top of guideline-recommended lipid modifying therapy', 'armGroupLabels': ['Placebo']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NewAmsterdam Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}