Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT06104358
Status:
WITHDRAWN
Last Update Posted:
2024-01-09
First Post:
2023-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ph 2a Study of HU6 on Energy Metabolism, Muscle and Liver Substrate Metabolism, and Mitochondrial Function in Subjects Who Are Overweight or Obese With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}], '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': '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'}]}}, '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': 0}}, 'statusModule': {'whyStopped': 'The protocol was redirected by the FDA to another division and will be resubmitted at a future date.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-05', 'studyFirstSubmitDate': '2023-10-11', 'studyFirstSubmitQcDate': '2023-10-23', 'lastUpdatePostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleeping Metabolic Rate (SMR) change from Baseline to 6 Months (26 weeks)', 'timeFrame': '26 weeks', 'description': 'Change from baseline in SMR at 6 months (26 weeks) as assessed by whole room indirect calorimetry (WRIC).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabete Type 2', 'Obesity']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo-controlled parallel group study of HU6 and placebo in subjects who are overweight or obese with T2D.\n\nThe study will be conducted in 4 stages.', 'detailedDescription': 'This is a randomized, double-blind, placebo-controlled parallel group study of HU6 and placebo in subjects who are overweight or obese with T2D.\n\nThe study will be conducted in 4 stages (Figure 1).\n\n* Stage 1: (screening) is conducted over a 29-day window (Day -48 to Day -20). Subjects who meet all of the eligibility criteria may proceed Stages 2 to 4 of the study.\n* Stage 2 (baseline \\[pre-randomization\\]) is conducted over a 19-day period prior to randomization and includes a 13-day run-in and the first 6-day inpatient assessment period. At the end of Stage 2, subjects will be randomized 1:1 to HU6 or placebo.\n* Stage 3 (double-blind dosing) is conducted after randomization. Day 1 is the first dose of double-blind study drug, and dosing continues over an approximate 26-week period. During this time, there will be study visits for safety, PK, and PD. Stage 3 of the study concludes with a 3-day run-in followed by the second 6-day inpatient assessment period.\n* Stage 4 (washout) is conducted after dosing has ended and includes an approximate 4-week washout duration including a 3-day run-in followed by the third inpatient assessment period (3-day duration). The last day of the 3-day inpatient stay is the end-of-study. (Note that there will be a separate early termination visit for any subject who prematurely discontinues from the study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able to understand the procedures and requirements of the study and provide written informed consent and authorization for protected health information disclosure.\n2. Willing and able to comply with the requirements of the study protocol.\n3. Male or female 18 to 70 years of age, inclusive, at time of informed consent.\n4. Body mass index (BMI) \\>28.0 kg/m2 and able to fit into the MRI machine.\n5. Subject has T2D meeting all of the following criteria:\n\nExclusion Criteria:\n\n1. Body weight \\>450 pounds.\n2. Subject-reported history of weight gain or loss \\>5% in 3 months prior to screening.\n3. The subject participates in programmed exercise \\>3 hours per week.'}, 'identificationModule': {'nctId': 'NCT06104358', 'briefTitle': 'Ph 2a Study of HU6 on Energy Metabolism, Muscle and Liver Substrate Metabolism, and Mitochondrial Function in Subjects Who Are Overweight or Obese With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rivus Pharmaceuticals, Inc.'}, 'officialTitle': 'A 6-Month, Randomized, Double-Blind, Placebo-controlled, Phase 2a Study of the Effects of HU6 on Energy Metabolism, Muscle and Liver Substrate Metabolism, and Mitochondrial Function in Subjects Who Are Overweight or Obese With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'RIV-HU6-204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Treatment HU6', 'description': 'Subjects who are randomized to active study drug will receive 450mg of HU6 for 14 day and then 600mg of HU6 for 168 days. N = 24', 'interventionNames': ['Drug: HU6']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo Comparator is non-active study drug. N = 24', 'interventionNames': ['Drug: HU6']}], 'interventions': [{'name': 'HU6', 'type': 'DRUG', 'description': 'HU6 is being evaluated for its effect on Energy Metabolism, Muscle and Liver Substrate Metabolism, and Mitochondrial Function', 'armGroupLabels': ['Active Treatment HU6', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'AdventHealth Translational Research Institute', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'overallOfficials': [{'name': 'Rachel Garner, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rivus Pharmaceuticals, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rivus Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}