Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2026-01-01 @ 10:29 PM
Study NCT ID:
NCT04826159
Status:
COMPLETED
Last Update Posted:
2025-06-29
First Post:
2021-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IMPROVE-DiCE: Study to Evaluate Effect of IMB-1018972 on Cardiac Energetics in T2DM & Obesity (Pt 1) With HFpEF (Pt 2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D058065', 'term': 'Diabetic Cardiomyopathies'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2021-03-18', 'studyFirstSubmitQcDate': '2021-03-29', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in cardiac PCr/ATP ratio at rest (Stage 1 and Stage 2) measured by 31P-MRS at baseline and at EOT with 200 mg BID of IMB-1018972.', 'timeFrame': 'Baseline, End of Treatment (up to 16 weeks)'}, {'measure': 'Change in cardiac PCr/ATP ratio with dobutamine stress (Stage 1 only) measured by 31P-MRS at baseline and at EOT with 200 mg BID of IMB-1018972', 'timeFrame': 'Baseline, End of Treatment (up to 8 weeks)'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability of IMB-1018972 as measured by incidence and severity of treatment emergent AEs (including AEs leading to study drug discontinuation and AEs leading to death), as well as incidence of treatment emergent SAEs', 'timeFrame': 'Baseline through End of Treatment (up to 16 weeks)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes', 'Diabetic Cardiomyopathies', 'HFpEF - Heart Failure With Preserved Ejection Fraction']}, 'referencesModule': {'references': [{'pmid': '41410037', 'type': 'DERIVED', 'citation': 'Hundertmark MJ, Birkhoelzer SM, Portwood C, Siu AG, Matthews V, Lewis AJ, Grist J, Mozes F, Henry JA, Patel J, Chamberlin P, Sarwar R, Yavari A, Dehbi HM, Rao P, Shi X, Zheng S, Robbins JM, Gerszten RE, Frenneaux MP, Valkovic L, Miller JJJJ, Neubauer S, Tyler DJ, Rider OJ. IMPROVE-DiCE, a 2-Part, Open-Label, Phase 2a Trial Evaluating the Safety and Effectiveness of Ninerafaxstat in Patients With Cardiometabolic Syndromes. Circulation. 2025 Dec 18. doi: 10.1161/CIRCULATIONAHA.125.074041. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the activity of IMB-1018972 on cardiac energetic reserve at rest and during stress and to assess safety and tolerability'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of type 2 diabetes\n* Elevated HbA1c\n* Elevated BMI\n* Preserved left ventricular ejection fraction\n* Diagnosis of HFpEF (Stage 2 only)\n\nExclusion Criteria:\n\n* Uncontrolled hypertension\n* Contraindication to magnetic resonance scanning\n* More than mild to moderate valvular heart disease\n* Atrial fibrillation\n* History of sustained ventricular tachycardia or cardiac arrest\n* Inability to exercise (Stage 2 only)\n* Clinically significant concurrent condition which could prevent the patient from performing any of the protocol-specified assessments, represent a safety concern if the patient participates in the trial or could confound trial assessments of safety or tolerability'}, 'identificationModule': {'nctId': 'NCT04826159', 'briefTitle': 'IMPROVE-DiCE: Study to Evaluate Effect of IMB-1018972 on Cardiac Energetics in T2DM & Obesity (Pt 1) With HFpEF (Pt 2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Imbria Pharmaceuticals, Inc.'}, 'officialTitle': 'A Pharmacodynamic Study to Evaluate the Effects of IMB-1018972 on Myocardial Energetics, Metabolism, and Function in Patients With Type 2 Diabetes.', 'orgStudyIdInfo': {'id': 'IMB101-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMB-1018972 200 mg', 'interventionNames': ['Drug: IMB-1018972']}], 'interventions': [{'name': 'IMB-1018972', 'type': 'DRUG', 'description': 'Modified release tablet for oral administration', 'armGroupLabels': ['IMB-1018972 200 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 9DU', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Oxford University Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Arash Yavari, BSc, MBBS, DPhil', 'role': 'STUDY_CHAIR', 'affiliation': 'Imbria Pharmaceuticals, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imbria Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Oxford', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}