Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-01-24 @ 11:24 PM
Study NCT ID:
NCT02063295
Status:
COMPLETED
Last Update Posted:
2016-07-18
First Post:
2014-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Hypothalamic Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003397', 'term': 'Craniopharyngioma'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C487952', 'term': 'CKD732'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'dispFirstSubmitDate': '2016-07-14', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-14', 'studyFirstSubmitDate': '2014-02-12', 'dispFirstSubmitQcDate': '2016-07-14', 'studyFirstSubmitQcDate': '2014-02-12', 'dispFirstPostDateStruct': {'date': '2016-07-18', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in body weight from baseline to the end of the randomized dosing period.', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in lipid profile (cholesterol, LDL, HDL, triglycerides) from baseline to the end of the randomized dosing period', 'timeFrame': '4 weeks'}, {'measure': 'Change in hs-CRP from baseline to the end of the randomized dosing period.', 'timeFrame': '4 weeks'}, {'measure': 'Change in hunger from baseline to the end of the randomized dosing period.', 'timeFrame': '4 weeks'}, {'measure': 'Change in quality of life from baseline to the end of the randomized dosing period.', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Beloranib', 'ZGN-440', 'ZGN-440 for injectable suspension', 'ZGN-433'], 'conditions': ['Obesity', 'Over-weight', 'Hypothalamic Injury', 'Craniopharyngioma']}, 'referencesModule': {'references': [{'pmid': '28261955', 'type': 'DERIVED', 'citation': 'Shoemaker A, Proietto J, Abuzzahab MJ, Markovic T, Malloy J, Kim DD. A randomized, placebo-controlled trial of beloranib for the treatment of hypothalamic injury-associated obesity. Diabetes Obes Metab. 2017 Aug;19(8):1165-1170. doi: 10.1111/dom.12928. Epub 2017 Apr 18.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of beloranib in obese subjects with hypothalamic injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obesity as a consequence of acquired anatomical hypothalamic damage as evidenced by BMI ≥30 and ≤60 kg/m2\n* Greater than 6 months post-treatment, including chemotherapy, surgery or radiation with resulting injury to the hypothalamus and/or the pituitary\n* Stable body weight for at least 3 months\n* Type 2 diabetes mellitus is allowed\n\nExclusion Criteria:\n\n* Males taking gonadotropin replacement therapy (LH/FSH)\n* Subjects who are planning any fertility treatment within 6 months of study participation\n* Use of weight loss agents, including herbal medications, in the past 3 months\n* Current or anticipated chronic use of narcotics or opiates\n* History of severe psychiatric disorders\n* Type 1 diabetes mellitus\n* Metabolic disorders or genetic disorders linked to obesity\n* History of any bariatric surgery\n* Participation in any clinical study with an investigational drug or device within the 3 months prior to enrollment in this study\n* Blood loss or donation \\>500 mL within the past 3 months\n* Females who are pregnant, nursing, intend to become pregnant during the study or any males who plan to father/conceive a child within 6 months after completion of study participation'}, 'identificationModule': {'nctId': 'NCT02063295', 'briefTitle': 'An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Hypothalamic Injury', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zafgen, Inc.'}, 'officialTitle': 'Randomized, Double-Blind, Placebo Controlled, Phase 2a Trial of ZGN-440 (Subcutaneous Beloranib in Suspension), A Novel Methionine Aminopeptidase 2 Inhibitor, in Obese Subjects With Hypothalamic Injury to Evaluate Weight Reduction and Safety Over 4 Weeks Followed by an Optional 4-Week Open-Label Extension', 'orgStudyIdInfo': {'id': 'ZAF-221'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'ZGN-440 sterile diluent', 'description': 'Subjects will receive placebo twice weekly subcutaneous injections for 4 weeks.', 'interventionNames': ['Drug: ZGN-440 sterile diluent']}, {'type': 'EXPERIMENTAL', 'label': 'ZGN-440 for injectable suspension', 'description': 'Subjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks.', 'interventionNames': ['Drug: ZGN-440 for injectable suspension']}], 'interventions': [{'name': 'ZGN-440 sterile diluent', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'ZGN-440 sterile diluent/placebo', 'armGroupLabels': ['ZGN-440 sterile diluent']}, {'name': 'ZGN-440 for injectable suspension', 'type': 'DRUG', 'otherNames': ['ZGN-440', 'Beloranib'], 'armGroupLabels': ['ZGN-440 for injectable suspension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': "Children's Hospitals and Clinics of Minnesota", 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '2006', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'The Boden Institute', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '3081', 'city': 'Heidelberg Heights', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Austin Health, Metabolic Disorders Centre', 'geoPoint': {'lat': -37.74313, 'lon': 145.05695}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zafgen, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}