Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-01-03 @ 6:42 PM
Study NCT ID:
NCT03374956
Status:
COMPLETED
Last Update Posted:
2023-07-18
First Post:
2017-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Individualized Obesity Pharmacotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C576188', 'term': 'Qsymia'}, {'id': 'D000069450', 'term': 'Liraglutide'}, {'id': 'D009271', 'term': 'Naltrexone'}, {'id': 'D016642', 'term': 'Bupropion'}, {'id': 'C000591595', 'term': 'bupropion hydrochloride, naltrexone hydrochoride drug combination'}, {'id': 'D010645', 'term': 'Phentermine'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011427', 'term': 'Propiophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000662', 'term': 'Amphetamines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'acosta.andres@mayo.edu', 'phone': '507-266-6931', 'title': 'Andres Acosta', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline to 12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Group', 'description': 'Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise\n\nPhentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily\n\nLiraglutide: dose of 3 mg subcutaneous daily\n\nNaltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)', 'otherNumAtRisk': 93, 'deathsNumAtRisk': 93, 'otherNumAffected': 23, 'seriousNumAtRisk': 93, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine\n\nPhentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily\n\nLiraglutide: dose of 3 mg subcutaneous daily\n\nNaltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)\n\nPhentermine: 15-37.5 mg oral daily', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 25, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'During study', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 100, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Total Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise\n\nPhentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily\n\nLiraglutide: dose of 3 mg subcutaneous daily\n\nNaltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine\n\nPhentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily\n\nLiraglutide: dose of 3 mg subcutaneous daily\n\nNaltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)\n\nPhentermine: 15-37.5 mg oral daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.7', 'groupId': 'OG000', 'lowerLimit': '-11', 'upperLimit': '-4.7'}, {'value': '-6.5', 'groupId': 'OG001', 'lowerLimit': '-11', 'upperLimit': '-2.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline to 12 weeks', 'description': 'Percent change in body weight', 'unitOfMeasure': 'percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise\n\nPhentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily\n\nLiraglutide: dose of 3 mg subcutaneous daily\n\nNaltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine\n\nPhentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily\n\nLiraglutide: dose of 3 mg subcutaneous daily\n\nNaltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)\n\nPhentermine: 15-37.5 mg oral daily'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline to 12 weeks', 'description': 'Percentage of participants who loss 5% or more of total body weight', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise\n\nPhentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily\n\nLiraglutide: dose of 3 mg subcutaneous daily\n\nNaltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine\n\nPhentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily\n\nLiraglutide: dose of 3 mg subcutaneous daily\n\nNaltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)\n\nPhentermine: 15-37.5 mg oral daily'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline to 12 weeks', 'description': 'Percentage of participants with at least 10% total body weight loss', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Group', 'description': 'Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise\n\nPhentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily\n\nLiraglutide: dose of 3 mg subcutaneous daily\n\nNaltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine\n\nPhentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily\n\nLiraglutide: dose of 3 mg subcutaneous daily\n\nNaltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)\n\nPhentermine: 15-37.5 mg oral daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Group', 'description': 'Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise\n\nPhentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily\n\nLiraglutide: dose of 3 mg subcutaneous daily\n\nNaltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine\n\nPhentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily\n\nLiraglutide: dose of 3 mg subcutaneous daily\n\nNaltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)\n\nPhentermine: 15-37.5 mg oral daily'}, {'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': '93', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '193', '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': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'spread': '16', 'groupId': 'BG000'}, {'value': '39', 'spread': '14', 'groupId': 'BG001'}, {'value': '39', 'spread': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '50', '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': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', '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': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '175', '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': '3', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '193', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-18', 'size': 1822474, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-06-26T14:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 193}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-27', 'studyFirstSubmitDate': '2017-11-09', 'resultsFirstSubmitDate': '2023-05-23', 'studyFirstSubmitQcDate': '2017-12-11', 'lastUpdatePostDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-27', 'studyFirstPostDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Total Body Weight', 'timeFrame': 'baseline to 12 weeks', 'description': 'Percent change in body weight'}], 'secondaryOutcomes': [{'measure': 'Percentage of Responders', 'timeFrame': 'baseline to 12 weeks', 'description': 'Percentage of participants who loss 5% or more of total body weight'}, {'measure': 'Percentage of Responders', 'timeFrame': 'baseline to 12 weeks', 'description': 'Percentage of participants with at least 10% total body weight loss'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pharmacological', 'Obesity Management', 'Individualized'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '33759389', 'type': 'DERIVED', 'citation': 'Acosta A, Camilleri M, Abu Dayyeh B, Calderon G, Gonzalez D, McRae A, Rossini W, Singh S, Burton D, Clark MM. Selection of Antiobesity Medications Based on Phenotypes Enhances Weight Loss: A Pragmatic Trial in an Obesity Clinic. Obesity (Silver Spring). 2021 Apr;29(4):662-671. doi: 10.1002/oby.23120.'}], 'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The researchers are trying to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss.', 'detailedDescription': 'All participants will be phenotype and participants will randomized to randomly assigned medications vs phenotype guided medications for obesity. All participants will receive a standard intense lifestyle intervention.All participants will be seen at 4 and 12 weeks. At the 12-week visit, participants will be unblinded to their "obesity-related phenotype" and they could contact their physician to continue a FDA-approved medication as part of clinical care. Study team will prospectively follow the patients\' weight, waist circumference and use of obesity medications every 3 months for 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Adults with obesity (BMI \\>30 Kg/m2); these will be otherwise healthy individuals with no unstable psychiatric disease and controlled comorbidities or other diseases.\n* Gender: Men or women. Women of childbearing potential will have negative pregnancy tests within 48 hours of enrollment and before each radiation exposure.\n\nExclusion criteria\n\n* Abdominal bariatric surgery\n* Positive history of chronic gastrointestinal diseases, or systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption, e.g., orlistat, within the last 6 months.\n* Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by an anxiety or depression score \\>11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up.\n* Hypersensitivity to any of the study medications.\n* No contraindications to all FDA-approved medications'}, 'identificationModule': {'nctId': 'NCT03374956', 'briefTitle': 'Individualized Obesity Pharmacotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Individualized Pharmacological Approach to Obesity Management: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '17-003449'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise', 'interventionNames': ['Drug: Phentermine-Topiramate', 'Drug: Liraglutide', 'Drug: Naltrexone/bupropion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine', 'interventionNames': ['Drug: Phentermine-Topiramate', 'Drug: Liraglutide', 'Drug: Naltrexone/bupropion', 'Drug: Phentermine']}], 'interventions': [{'name': 'Phentermine-Topiramate', 'type': 'DRUG', 'otherNames': ['Qsymia'], 'description': 'Extended Release at dose of 7.5/46 mg oral daily', 'armGroupLabels': ['Control Group', 'Intervention group']}, {'name': 'Liraglutide', 'type': 'DRUG', 'otherNames': ['Saxenda'], 'description': 'dose of 3 mg subcutaneous daily', 'armGroupLabels': ['Control Group', 'Intervention group']}, {'name': 'Naltrexone/bupropion', 'type': 'DRUG', 'otherNames': ['Contrave'], 'description': 'Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)', 'armGroupLabels': ['Control Group', 'Intervention group']}, {'name': 'Phentermine', 'type': 'DRUG', 'otherNames': ['Adipex-P', 'Lomaira'], 'description': '15-37.5 mg oral daily', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Andres J Acosta', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Andres J. Acosta, M.D., Ph.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}