Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT05532020
Status:
UNKNOWN
Last Update Posted:
2022-09-08
First Post:
2022-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Open-Label Study of Diazoxide Choline in Patients With Genetic Obesities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-07', 'studyFirstSubmitDate': '2022-09-04', 'studyFirstSubmitQcDate': '2022-09-07', 'lastUpdatePostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants who achieve at least 5% body weight reduction', 'timeFrame': 'Baseline to Week 26', 'description': 'Proportion of participants who achieve at least 5% body weight reduction'}], 'secondaryOutcomes': [{'measure': 'Leptin', 'timeFrame': 'Baseline to Week 26', 'description': 'Change from Baseline in serum leptin'}, {'measure': 'Fasting serum insulin', 'timeFrame': 'Baseline to Week 26', 'description': 'Change in fasting serum insulin'}, {'measure': 'Body fat mass', 'timeFrame': 'Baseline to Week 26', 'description': 'Change in body fat mass (DXA)'}, {'measure': 'Feelings of hunger', 'timeFrame': 'Baseline to Week 26', 'description': 'Change in self-reported feelings of hunger measured on a visual analog scale (VAS), 0 - 100 with 0 being no feelings of hunger and 100 being the most extreme sensation of hunger'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SH2B1 deficiency obesity', 'Obesity associated with PCSK1 mutation', '(rs6232 variant)', 'SIM1 deficiency obesity', 'Genetic obesity'], 'conditions': ['SH2B1 Deficiency Obesity', 'Obesity Associated With PCSK1 Mutation (rs6232 Variant)', 'SIM1 Deficiency Obesity']}, 'descriptionModule': {'briefSummary': 'This is a phase 2 open-label, one-arm, clinical study to evaluate the efficacy and safety of DCCR (diazoxide choline) extended-release tablets over 1 year of treatment, in patients with genetic obesities.', 'detailedDescription': 'Patients aged 5 years and older with obesity due to SH2B1 deficiency obesity, obesity associated with PCSK1 mutation (rs6232 variant), or SIM1 deficiency obesity will be enrolled into this phase 2 open-label clinical trial at a single clinical center in North America. All eligible participants will receive DCCR (diazoxide choline) extended-release tablets for 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Provide voluntary, written informed consent (parent(s) / legal guardian(s) of patient); provide voluntary, written assent (patients, as appropriate)\n* Genetically-confirmed diagnosis of SH2B1 deficiency obesity, obesity associated with PCSK1 mutation (rs6232 variant), or SIM1 deficiency obesity\n\nKey Exclusion Criteria:\n\n* Have participated in an interventional clinical study (i.e., investigational drug or device, approved drugs or device evaluated for unapproved use) within 60 days prior to Screening\n* Any known disease and/or condition, which would prevent, in the opinion of the Investigator, the patient from completing all study visits and assessments required by the protocol\n* Positive urine pregnancy test (in females of child-bearing potential) or females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 30 days after study participation'}, 'identificationModule': {'nctId': 'NCT05532020', 'briefTitle': 'An Open-Label Study of Diazoxide Choline in Patients With Genetic Obesities', 'organization': {'class': 'INDUSTRY', 'fullName': 'Soleno Therapeutics, Inc.'}, 'officialTitle': 'An Open-Label Study to Assess the Preliminary Efficacy and Safety of DCCR (Diazoxide Choline) Extended-Release Tablets in Patients With Genetic Obesities', 'orgStudyIdInfo': {'id': 'C615'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open-label DCCR', 'description': '75 - 525 mg DCCR', 'interventionNames': ['Drug: DCCR (diazoxide choline) extended-release tablets']}], 'interventions': [{'name': 'DCCR (diazoxide choline) extended-release tablets', 'type': 'DRUG', 'otherNames': ['DCCR'], 'description': 'All participants will be titrated over a four week period to the maintenance dose. Participants will take DCCR daily for up to 52 weeks.', 'armGroupLabels': ['Open-label DCCR']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Project Manager', 'role': 'CONTACT', 'email': 'C615ProjectManager@soleno.life', 'phone': '650-353-2051'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soleno Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}