Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
Study NCT ID:
NCT07029412
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate Efficacy and Dose Response of Imapextide (STEADI)
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': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-01-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-06-11', 'studyFirstSubmitQcDate': '2025-06-18', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from baseline to post-treatment in glucose nadir during a standardized MMTT following different dose levels of MBX 1416.', 'timeFrame': 'The duration of the study will be approximately 67 days from screening to end of study (EoS) for any given participant'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PBH'], 'conditions': ['Postbariatric Hypoglycemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the preliminary efficacy of single SC administration of MBX 1416 at different dose levels in patients with PBH', 'detailedDescription': 'This is a Phase 2a, open-label, exploratory study to evaluate preliminary efficacy of SC MBX 1416 in patients with PBH. Approximately 10 patients aged 18 to 75 (inclusive) years with history of hypoglycemia following Roux-en-Y or sleeve gastrectomy will be included in the study. Participants will undergo 3 mixed-meal tolerance tests, one at baseline and again 48 hours after each MBX 1416 administration, to evaluate the effect of MBX 1416 on increasing post-prandial glucose nadir. MBX 1416 effect in reducing post-prandial insulin and C-peptide peaks will also be evaluated'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Participant must be ≥18 to ≤75 years of age at the time of signing the informed consent.\n2. Participants must have undergone RYGB or SG surgery at least 12 months prior to study entry.\n3. Participants should have a documented history of PBH, defined as Whipple's triad (symptomatic hypoglycemia, capillary glucose ≤54 mg/dL, with symptom resolution by carbohydrate administration) and a minimum of 1 symptomatic hypoglycemic episode per month by patient report.\n4. Participants who are either treatment naïve or who are no longer using (i.e., have discontinued as part of their usual medical care) agents known to interfere with glucose metabolism at the time of screening.\n5. Participants must have a body mass index (BMI) \\<45 kg/m2 at screening.\n6. Must have signed informed consent.\n\nExclusion Criteria:\n\n1. History of, or currently active, significant illness or medical disorders that in the opinion of the investigator may preclude participants from participating in the study.\n2. Currently on-going type II diabetes mellitus.\n3. History of hypoglycemia prior to bariatric surgery.\n4. History of insulinoma or other endogenous hyperinsulinemia illness (e.g., congenital hyperinsulinism)."}, 'identificationModule': {'nctId': 'NCT07029412', 'briefTitle': 'Study to Evaluate Efficacy and Dose Response of Imapextide (STEADI)', 'organization': {'class': 'INDUSTRY', 'fullName': 'MBX Biosciences'}, 'officialTitle': 'A Phase 2a, Open-label, Exploratory Study to Evaluate Preliminary Efficacy of Subcutaneous MBX 1416 in Patients With Postbariatric Hypoglycemia (The STEADI Study)', 'orgStudyIdInfo': {'id': 'MBX-1P2002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MBX 1416 (INN imapextide)', 'description': 'Single subcutaneous administration at different dose levels', 'interventionNames': ['Drug: MBX 1416 (INN imapextide)']}], 'interventions': [{'name': 'MBX 1416 (INN imapextide)', 'type': 'DRUG', 'description': 'A single subcutaneous injection of MBX 1416 at a low dose and a high dose approximately 2 weeks apart.', 'armGroupLabels': ['MBX 1416 (INN imapextide)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'MBX Biosciences Investigational Site', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '28557', 'city': 'Morehead City', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'MBX Biosciences Investigational Site', 'geoPoint': {'lat': 34.72294, 'lon': -76.72604}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'MBX Biosciences Investigational Site', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'MBX Biosciences Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'centralContacts': [{'name': 'Elisa Fabbrini, MD, PhD', 'role': 'CONTACT', 'email': 'MBX1416.Clinicaltrials@mbxbio.com', 'phone': '844-877-4473'}, {'name': 'Stewart Hallett', 'role': 'CONTACT', 'email': 'MBX1416.Clinicaltrials@mbxbio.com', 'phone': '844-877-4473'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MBX Biosciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}