Ignite Creation Date:
2025-12-24 @ 11:54 AM
Ignite Modification Date:
2025-12-28 @ 8:52 PM
Study NCT ID:
NCT01028261
Status:
COMPLETED
Last Update Posted:
2012-01-11
First Post:
2009-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Pharmacokinetics of Multiple Doses of ZGN-433 in Obese Female Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-09', 'studyFirstSubmitDate': '2009-12-07', 'studyFirstSubmitQcDate': '2009-12-07', 'lastUpdatePostDateStruct': {'date': '2012-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measures of the safety and tolerability of ZGN-433 include documentation of adverse events and changes (compared to baseline) in vital signs, physical examination, heart rhythm, and laboratory tests.', 'timeFrame': 'Approximately 2 months'}], 'secondaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'Approximately 2 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obese', 'Obesity', 'Overweight'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess whether multiple doses of ZGN-433 is safe and well tolerated in obese female subjects. The study will also provide information on how much ZGN-433 gets into the blood, how long does it stay in the body, and how it affects other biological markers.', 'detailedDescription': 'This protocol is designed to test the safety and preliminary efficacy of a drug called ZGN-433. It is to be tested for its ability to reduce weight in severely obese female subjects who are post menopausal or infertile.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obese, otherwise healthy females\n* Post menopausal or infertile\n* Weight ≥ 50 kg\n* BMI ≥ 32 and ≤ 45 kg/m2\n\nExclusion Criteria:\n\n* Use of weight loss agents in the past month\n* History of eating disorder\n* History of diabetes or other endocrine disorder\n* History of gastric bypass\n* Current smokers\n* Unstable body weight during the past 3 months'}, 'identificationModule': {'nctId': 'NCT01028261', 'briefTitle': 'Safety, Tolerability and Pharmacokinetics of Multiple Doses of ZGN-433 in Obese Female Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zafgen, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study, to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZGN-433 in Obese Volunteers', 'orgStudyIdInfo': {'id': 'ZAF-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ZGN-433', 'interventionNames': ['Drug: ZGN-433']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline', 'interventionNames': ['Drug: ZGN-433']}], 'interventions': [{'name': 'ZGN-433', 'type': 'DRUG', 'otherNames': ['Beloranib hemioxalate'], 'description': 'Subjects will receive placebo or ZGN-433 twice weekly over 6 weeks treatment period for a total of 12 doses. A range of doses will be evaluated.', 'armGroupLabels': ['Normal Saline', 'ZGN-433']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4006', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': "Q-Pharm Clinics, Royal Brisbane and Women's Hospital", 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '3084', 'city': 'Heidelberg', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Nucleus Network', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}], 'overallOfficials': [{'name': 'James E Vath, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zafgen, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zafgen, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}