Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-01-04 @ 8:46 AM
Study NCT ID:
NCT03254368
Status:
COMPLETED
Last Update Posted:
2019-05-24
First Post:
2017-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess the Effects and Safety of ZGN-1061 in Overweight and Obese Participants With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629660', 'term': 'ZGN-1061'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 188}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-22', 'studyFirstSubmitDate': '2017-08-07', 'studyFirstSubmitQcDate': '2017-08-15', 'lastUpdatePostDateStruct': {'date': '2019-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c', 'timeFrame': '12 weeks'}, {'measure': 'Safety and tolerability as assessed by incidence of adverse events', 'timeFrame': '12 weeks'}, {'measure': 'Safety and tolerability as assessed by change in medication use, vital signs, physical examination findings, mental well-being questionnaires, laboratory evaluations, and electrocardiogram results', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in body weight', 'timeFrame': '12 weeks'}, {'measure': 'Change in fasting plasma glucose', 'timeFrame': '12 weeks'}, {'measure': 'Change in insulin', 'timeFrame': '12 weeks'}, {'measure': 'Change in C-peptide', 'timeFrame': '12 weeks'}, {'measure': 'Change in proinsulin', 'timeFrame': '12 weeks'}, {'measure': 'Change in glucagon', 'timeFrame': '12 weeks'}, {'measure': 'Proportion of subjects achieving HbA1c <7% and ≤6.5%', 'timeFrame': '12 weeks'}, {'measure': 'Change in beta-cell function', 'timeFrame': '12 weeks'}, {'measure': 'Change in insulin sensitivity', 'timeFrame': '12 weeks'}, {'measure': 'Change in preprandial and postprandial glycemic parameters as assessed by a mixed meal tolerance test in a subset of subjects', 'timeFrame': '12 weeks'}, {'measure': 'Change in waist and hip circumference', 'timeFrame': '12 weeks'}, {'measure': 'Change in biomarkers relevant to obesity and/or type 2 diabetes', 'timeFrame': '12 weeks'}, {'measure': 'Change in patient reported outcomes measures', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Methionine Aminopeptidase 2 Inhibitor', 'Diabetes Mellitus, Type 2', 'Blood Glucose', 'Overweight', 'Obesity'], 'conditions': ['Type 2 Diabetes Mellitus', 'Overweight and Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of the study drug ZGN-1061 in participants with type 2 diabetes.', 'detailedDescription': 'Participants will be enrolled in 1 of 2 groups. Approximately 120 participants will receive 0.05, 0.3, or 0.9 mg of ZGN-1061 or placebo (Group 1). An additional 40 participants will receive 0.9 or 1.8 mg of ZGN-1061 or placebo (Group 2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects must meet the following criteria to participate in this study:\n\n* Be between the ages of 18 and 70 years, inclusive.\n* Overweight or obese with a body mass index of at least 27 kg/m².\n* Have type 2 diabetes with HbA1c between 7% and 11%.\n* For subjects taking approved antidiabetes medications, the doses must be stable as determined by the study doctor.\n* For subjects who have had weight-loss surgery (example: gastric banding), the procedure must have occurred at least 1 year ago, and be verified with documentation or by a health professional associated with the surgery.\n\nExclusion Criteria:\n\nSubjects cannot participate in this research study if they meet any of the following:\n\n* Have taken another study drug or study device within the past 6 months.\n* Are taking certain prescribed medications including narcotics or opiates.\n* Consistent recent use of insulin.\n* Have had recent major surgery or prolonged bed rest, or planning or likely to undergo any surgery during the research study.\n* Have a history of bleeding disorders or risk factors for excessive blood clotting.\n* Have difficulty giving blood.\n* Have a history of drug and/or alcohol abuse.'}, 'identificationModule': {'nctId': 'NCT03254368', 'briefTitle': 'Study to Assess the Effects and Safety of ZGN-1061 in Overweight and Obese Participants With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zafgen, Inc.'}, 'officialTitle': 'Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of ZGN-1061 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus to Evaluate Glycemic Control, Safety, and Tolerability Over 12 Weeks', 'orgStudyIdInfo': {'id': 'ZAF-1061-201'}, 'secondaryIdInfos': [{'id': 'U1111-1196-7527', 'type': 'REGISTRY', 'domain': 'International Clinical Trials Registry Platform'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.05 mg ZGN-1061 (A)', 'description': '0.05 mg ZGN-1061 subcutaneous injection once every 3 days', 'interventionNames': ['Drug: ZGN-1061']}, {'type': 'EXPERIMENTAL', 'label': '0.3 mg ZGN-1061 (B)', 'description': '0.3 mg ZGN-1061 subcutaneous injection once every 3 days', 'interventionNames': ['Drug: ZGN-1061']}, {'type': 'EXPERIMENTAL', 'label': '0.9 mg ZGN-1061 (C)', 'description': '0.9 mg ZGN-1061 subcutaneous injection once every 3 days', 'interventionNames': ['Drug: ZGN-1061']}, {'type': 'EXPERIMENTAL', 'label': '1.8 mg ZGN-1061 (CC)', 'description': '1.8 mg ZGN-1061 subcutaneous injection once every 3 days', 'interventionNames': ['Drug: ZGN-1061']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (D)', 'description': 'Placebo subcutaneous injection once every 3 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ZGN-1061', 'type': 'DRUG', 'description': 'ZGN-1061 is a methionine aminopeptidase 2 inhibitor', 'armGroupLabels': ['0.05 mg ZGN-1061 (A)', '0.3 mg ZGN-1061 (B)', '0.9 mg ZGN-1061 (C)', '1.8 mg ZGN-1061 (CC)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo has the same excipients and appearance as ZGN-1061', 'armGroupLabels': ['Placebo (D)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2450', 'city': 'Coffs Harbour', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Coffs Harbour GP SuperClinic', 'geoPoint': {'lat': -30.29626, 'lon': 153.11351}}, {'zip': '2450', 'city': 'Coffs Harbour', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Northside Health', 'geoPoint': {'lat': -30.29626, 'lon': 153.11351}}, {'zip': '2291', 'city': 'Merewether', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'The Aim Centre', 'geoPoint': {'lat': -32.94801, 'lon': 151.74325}}, {'zip': '2006', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'The Boden Institute', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2010', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Holdsworth House Medical Practice', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2289', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Pendlebury Research', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '4006', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Q-Pharm', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '4222', 'city': 'Southport', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Griffith University, Gold Coast Campus', 'geoPoint': {'lat': -27.96724, 'lon': 153.39796}}, {'zip': '5041', 'city': 'Daw Park', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Southern Adelaide Diabetes & Endocrine Services', 'geoPoint': {'lat': -34.98975, 'lon': 138.58407}}, {'zip': '3128', 'city': 'Box Hill', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Eastern Clinical Research Unit (ECRU)', 'geoPoint': {'lat': -37.81887, 'lon': 145.12545}}, {'zip': '3218', 'city': 'Geelong', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Barwon Health', 'geoPoint': {'lat': -38.14711, 'lon': 144.36069}}, {'zip': '3050', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Royal Melbourne Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '1021', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Optimal Clinical Trials', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '2025', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Middlemore Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '8011', 'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Christchurch Diabetes Centre', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'zip': '8024', 'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Southern Clinical Trials', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'zip': '8140', 'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Lipid and Diabetes Research Group', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'zip': '3206', 'city': 'Hamilton', 'country': 'New Zealand', 'facility': 'Clinical Trials New Zealand Ltd', 'geoPoint': {'lat': -37.78333, 'lon': 175.28333}}, {'zip': '4130', 'city': 'Hastings', 'country': 'New Zealand', 'facility': 'P3 Research Hawkes Bay', 'geoPoint': {'lat': -39.6381, 'lon': 176.84918}}, {'zip': '6021', 'city': 'Newtown', 'country': 'New Zealand', 'facility': 'P3 Research Wellington', 'geoPoint': {'lat': -41.31115, 'lon': 174.77935}}, {'zip': '3010', 'city': 'Rotorua', 'country': 'New Zealand', 'facility': 'Lakeland Clinical Trials', 'geoPoint': {'lat': -38.13874, 'lon': 176.24516}}, {'zip': '3110', 'city': 'Tauranga', 'country': 'New Zealand', 'facility': 'P3 Research Tauranga', 'geoPoint': {'lat': -37.68611, 'lon': 176.16667}}, {'zip': '6021', 'city': 'Wellington', 'country': 'New Zealand', 'facility': 'Wellington Hospital', 'geoPoint': {'lat': -41.28664, 'lon': 174.77557}}], 'overallOfficials': [{'name': 'Dennis Kim, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Zafgen, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zafgen, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}