Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2025-12-27 @ 10:14 PM
Study NCT ID:
NCT01372761
Status:
COMPLETED
Last Update Posted:
2011-12-30
First Post:
2011-06-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics, Safety, Tolerability and Efficacy of Intravenous 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C487952', 'term': 'CKD732'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, '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': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-28', 'studyFirstSubmitDate': '2011-06-08', 'studyFirstSubmitQcDate': '2011-06-10', 'lastUpdatePostDateStruct': {'date': '2011-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Demonstrate safe doses of ZGN-433 for reduction of body weight in obese female volunteers.', 'timeFrame': 'Approximately 4 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Incidence, severity and dose-relationship of adverse events as well as changes in physical examinations, ECGs, vital signs and/or laboratory evaluations as a measure of safety and tolerability.', 'timeFrame': 'Approximately 4 weeks'}, {'measure': 'Peak plasma concentration of ZGN-433 to assess relationship to weight loss.', 'timeFrame': 'Approximately 4 weeks'}, {'measure': 'Elimination half-life of ZGN-433 to assess relationship to weight loss.', 'timeFrame': 'Approximately 4 weeks'}]}, '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 are safe and effective.', 'detailedDescription': 'This protocol is designed to test the safety and efficacy of a drug called Beloranib (ZGN-433). It is to be tested for its ability to reduce weight in obese female subjects who are of non-childbearing potential. The study will provide information on how much ZGN-433 gets into the blood, how long it stays in the body, and how it affects other biological markers.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obese but otherwise healthy females\n* Non-childbearing potential (surgically sterile, post-menopausal, or receiving implanted or injectable contraceptive for at least 3 months)\n* BMI ≥ 30 and ≤ 50 kg/m2\n* Stable body weight during the past month\n\nExclusion Criteria:\n\n* Use of weight loss agents in the past month\n* History of eating disorder\n* History of gastric bypass surgery\n* Current smokers'}, 'identificationModule': {'nctId': 'NCT01372761', 'briefTitle': 'Pharmacokinetics, Safety, Tolerability and Efficacy of Intravenous Doses of ZGN-433 in Obese Female Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zafgen, Inc.'}, 'officialTitle': 'Phase 1b Trial of Beloranib, a Novel Methionine Aminopeptidase 2 (MetAP-2) Inhibitor for Treatment of Extreme Obesity: Randomized, Double-Blind, Placebo-Controlled, Escalating Doses in Female Volunteers', 'orgStudyIdInfo': {'id': 'ZAF-003AUS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline', 'interventionNames': ['Drug: Normal Saline']}, {'type': 'EXPERIMENTAL', 'label': 'ZGN-433', 'interventionNames': ['Drug: ZGN-433']}], 'interventions': [{'name': 'ZGN-433', 'type': 'DRUG', 'otherNames': ['Beloranib'], 'description': 'Subjects will receive placebo or ZGN-433 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.', 'armGroupLabels': ['ZGN-433']}, {'name': 'Normal Saline', 'type': 'DRUG', 'description': 'Subjects will receive placebo or ZGN-433 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.', 'armGroupLabels': ['Normal Saline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': "Q-Pharm Clinics, Royal Brisbane and Women's Hospital", 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}], 'overallOfficials': [{'name': 'J K Marjason, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Q-Pharm Clinics, Royal Brisbane and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zafgen, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}