Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-01-03 @ 4:38 AM
Study NCT ID:
NCT03373435
Status:
COMPLETED
Last Update Posted:
2022-07-18
First Post:
2017-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Exendin 9-39 in Patients With Postbariatric Hypoglycemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C083773', 'term': 'exendin (9-39)'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@eigerbio.com', 'phone': '1-650-272-6138', 'title': 'Senior VP, Clinical Development', 'organization': 'Eiger BioPharmaceuticals, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 Months', 'description': 'Patients were evaluated and questioned to identify adverse events during the course of the study by the Investigator.', 'eventGroups': [{'id': 'EG000', 'title': 'Avexitide 30 mg BID', 'description': 'patients (treatment group 1 + treatment 2) received 30 mg twice a day', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 3, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Avexitide 60 mg QD', 'description': 'patients (treatment group 1 + treatment group 2)) received 60 mg once a day.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 9, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Patients received placebo in treatment period 1 (initial 14 days) in the study.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 14, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Postprandial Glucose Nadir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Avexitide 30 mg BID', 'description': 'patients (treatment group 1 + treatment 2) received 30 mg twice a day'}, {'id': 'OG001', 'title': 'Avexitide 60 mg QD', 'description': 'patients (treatment group 1 + treatment group 2)) receive 60 mg once a day.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Patients received placebo in treatment period 1 (initial 14 days) in the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.1', 'spread': '16.5', 'groupId': 'OG000'}, {'value': '59.2', 'spread': '16.1', 'groupId': 'OG001'}, {'value': '47.1', 'spread': '12.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 hours following a liquid meal', 'description': 'Plasma glucose nadir occurring within 3 hours of mixed-meal tolerance testing (MMTT)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population are both treatment group 1 and treatment group 2. One participant was excluded from the efficacy analysis due to major protocol deviation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Group 1', 'description': 'Placebo first, then exendin 9-39 30 mg BID, then exendin 9-39 60 mg QD\n\nexendin 9-39: Exendin 9-39 is a competitive antagonist of glucagon-like peptide-1 (GLP-1) at its receptor.\n\nPlacebo: Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39.'}, {'id': 'FG001', 'title': 'Treatment Group 2', 'description': 'Placebo first, then exendin 9-39 60 mg QD, then exendin 9-39 30 mg BID\n\nexendin 9-39: Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.\n\nPlacebo: Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39.'}], 'periods': [{'title': 'Treatment Period 1 (14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2 (14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 3 (14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Group 1 (Placebo, Exendin 9-39 30 mg BID, Exendin 9-39 60 mg QD)', 'description': 'Placebo, exendin 9-39 30 mg BID, exendin 9-39 60 mg QD\n\nexendin 9-39: Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.\n\nPlacebo: Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39.'}, {'id': 'BG001', 'title': 'Treatment Group 2 (Placebo, Exendin 9-39 60 mg QD, Exendin 9-39 30 mg BID)', 'description': 'Placebo, exendin 9-39 60 mg QD, exendin 9-39 30 mg BID\n\nexendin 9-39: Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.\n\nPlacebo: Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '81.6', 'spread': '7.3', 'groupId': 'BG000'}, {'value': '81.0', 'spread': '16.1', 'groupId': 'BG001'}, {'value': '81.23', 'spread': '12.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '30.0', 'spread': '3.1', 'groupId': 'BG000'}, {'value': '29.3', 'spread': '4.9', 'groupId': 'BG001'}, {'value': '29.6', 'spread': '4.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-31', 'size': 176921, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-13T01:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'dispFirstSubmitDate': '2020-01-27', 'completionDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-30', 'studyFirstSubmitDate': '2017-11-27', 'dispFirstSubmitQcDate': '2022-06-20', 'resultsFirstSubmitDate': '2022-05-17', 'studyFirstSubmitQcDate': '2017-12-08', 'dispFirstPostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-20', 'studyFirstPostDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postprandial Glucose Nadir', 'timeFrame': '3 hours following a liquid meal', 'description': 'Plasma glucose nadir occurring within 3 hours of mixed-meal tolerance testing (MMTT)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postbariatric Hypoglycemia']}, 'referencesModule': {'references': [{'pmid': '33616643', 'type': 'RESULT', 'citation': 'Craig CM, Lawler HM, Lee CJE, Tan M, Davis DB, Tong J, Glodowski M, Rogowitz E, Karaman R, McLaughlin TL, Porter L. PREVENT: A Randomized, Placebo-controlled Crossover Trial of Avexitide for Treatment of Postbariatric Hypoglycemia. J Clin Endocrinol Metab. 2021 Jul 13;106(8):e3235-e3248. doi: 10.1210/clinem/dgab103.'}]}, 'descriptionModule': {'briefSummary': 'This clinical study will evaluate whether taking an investigational drug called exendin 9-39 is safe, well-tolerated, and helps to prevent low blood sugar in people who have had bariatric surgery and later develop a rare condition called postbariatric hypoglycemia (PBH).', 'detailedDescription': 'This is a Phase 2, multicenter, randomized, single-blind, placebo-controlled cross-over study in patients with refractory PBH.\n\nParticipants will be randomized and assigned in a 1:1 ratio to one of two treatment arms. All participants will receive 2 dosing regimens of exendin 9-39 and matching placebo self-administered via subcutaneous (SC) injection.\n\nParticipants will undergo in-clinic mixed meal tolerance test (MMTT) provocation with concomitant blood draws and symptom assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) of up to 40 kg/m2\n* Roux-en-Y gastric bypass (RYGB) surgery performed ≥12 months prior\n* Diagnosis of PBH\n* At least 2 episodes during screening 2-week run-in phase of severe hypoglycemia\n\nExclusion Criteria:\n\n* Other cause of endogenous hyperinsulinism other than PBH\n* Metabolic or bariatric surgical procedure other than RYGB\n* History of non-RYGB upper GI surgery\n* Use of agents that may interfere with glucose metabolism'}, 'identificationModule': {'nctId': 'NCT03373435', 'acronym': 'PREVENT', 'briefTitle': 'Safety and Efficacy of Exendin 9-39 in Patients With Postbariatric Hypoglycemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eiger BioPharmaceuticals'}, 'officialTitle': 'A Phase 2, Multicenter, Randomized, Single-Blind, Placebo-Controlled Cross-over Study to Assess the Efficacy and Safety of Exendin 9-39 in Patients With Postbariatric Hypoglycemia', 'orgStudyIdInfo': {'id': 'EIG-EXD-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group 1', 'description': 'patients will receive two dose regimens of exendin 9-39 and one placebo', 'interventionNames': ['Drug: exendin 9-39', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Group 2', 'description': 'patients will receive two dose regimens of exendin 9-39 and one placebo (in a different sequence than Treatment Group 1)', 'interventionNames': ['Drug: exendin 9-39', 'Other: Placebo']}], 'interventions': [{'name': 'exendin 9-39', 'type': 'DRUG', 'otherNames': ['Avexitide'], 'description': 'Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.', 'armGroupLabels': ['Treatment Group 1', 'Treatment Group 2']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39.', 'armGroupLabels': ['Treatment Group 1', 'Treatment Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado, Denver', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Early Phase Clinical Research', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Colleen Craig, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eiger BioPharmaceuticals, Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eiger BioPharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}