Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-03-04 @ 10:50 PM
Study NCT ID:
NCT03353220
Status:
TERMINATED
Last Update Posted:
2024-03-27
First Post:
2017-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Predictors of Lorcaserin-Induced Weight Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], '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'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C506658', 'term': 'lorcaserin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sw22@cumc.columbia.edu', 'phone': '212-305-3725', 'title': 'Sharon Wardlaw, MD', 'organization': 'Columbia University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Study was stopped prematurely during Phase 2 due to lack of drug supply.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 2 years', 'eventGroups': [{'id': 'EG000', 'title': 'LOR Time Period', 'description': 'Phase 1: These participants received lorcaserin (Belviq) 10 mg before the washout OR crossed over after the washout to receive lorcaserin twice a day for 7 days.\n\nBelviq: Belviq is an oral drug.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Time Period', 'description': 'Phase 1: These participants either received placebo before the washout OR crossed over after washout to receive placebo twice a day for 7 days.\n\nPlacebo: The placebo is made to mimic Belviq, but does not contain any active drug.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Differences in Food Intake During a Laboratory Test Meal After Lorcaserin for One Week Compared to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Phase 1: These participants either received placebo before the washout OR crossed over after washout to receive placebo twice a day for 7 days.\n\nPlacebo: The placebo is made to mimic Belviq, but does not contain any active drug.'}, {'id': 'OG001', 'title': 'Lorcaserin', 'description': 'Phase 1: These participants received lorcaserin (Belviq) 10 mg before the washout OR crossed over after the washout to receive lorcaserin twice a day for 7 days.\n\nBelviq: Belviq is an oral drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '919.8', 'spread': '118.7', 'groupId': 'OG000'}, {'value': '891.9', 'spread': '109.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.65', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'paired t test', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'First test meal and follow-up test meal (approximately up to 5 weeks)', 'description': 'This is designed to measure food Intake (average calories consumed during test meal), in order to determine if long-term lorcaserin induced weight loss is predicted by the short-term differences in calories consumed during the test meal.', 'unitOfMeasure': 'kcal', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The data information were collected and analyzed separately for the time period of placebo or drug exposure - i.e., comparing participants receiving placebo only OR Lorcaserin only (instead of comparing Arm A and Arm B). At one point, the same participant was exposed to either placebo OR Lorcaserin. Therefore, there are 30 analyzed for placebo only and 30 analyzed for drug only.'}, {'type': 'PRIMARY', 'title': 'Mean Differences in POMC Concentrations (Fmol/ml) in CSF After Lorcaserin for One Week Compared to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Phase 1: These participants either received placebo before the washout OR crossed over after washout to receive placebo twice a day for 7 days.\n\nPlacebo: The placebo is made to mimic Belviq, but does not contain any active drug.'}, {'id': 'OG001', 'title': 'Lorcaserin', 'description': 'Phase 1: These participants received lorcaserin (Belviq) 10 mg before the washout OR crossed over after the washout to receive lorcaserin twice a day for 7 days.\n\nBelviq: Belviq is an oral drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '256.9', 'spread': '18.5', 'groupId': 'OG000'}, {'value': '225.0', 'spread': '15.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'paired t test', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, up to 5 weeks', 'description': 'This is designed to measure mean CSF proopiomelanocortin (POMC) concentrations (fmol/ml), in order to determine if long-term lorcaserin induced weight loss can be predicted by differences in CSF POMC concentrations.', 'unitOfMeasure': 'fmol/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The data information were collected and analyzed separately for the time period of placebo or drug exposure - i.e., comparing participants receiving placebo only OR Lorcaserin only (instead of comparing Arm A and Arm B). At one point, the same participant was exposed to either placebo OR Lorcaserin. Therefore, there are 30 analyzed for placebo only and 30 analyzed for drug only.'}, {'type': 'SECONDARY', 'title': 'CSF Concentrations of ß-endorphin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Phase 1: These participants either received placebo before the washout OR crossed over after washout to receive placebo twice a day for 7 days.\n\nPlacebo: The placebo is made to mimic Belviq, but does not contain any active drug.'}, {'id': 'OG001', 'title': 'Lorcaserin', 'description': 'Phase 1: These participants received lorcaserin (Belviq) 10 mg before the washout OR crossed over after the washout to receive lorcaserin twice a day for 7 days.\n\nBelviq: Belviq is an oral drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.07', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '55.8', 'spread': '3.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0017', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'paired t test', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, up to 5 weeks', 'description': 'Mean differences in levels of ß-endorphin, a POMC-derived peptide, in CSF after lorcaserin for one week compared to placebo in order to determine if long-term lorcaserin induced weight loss can be predicted using short-term differences in CSF concentrations of ß-endorphin.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The data information were collected and analyzed separately for the time period of placebo or drug exposure - i.e., comparing participants receiving placebo only OR Lorcaserin only (instead of comparing Arm A and Arm B). At one point, the same participant was exposed to either placebo OR Lorcaserin. Therefore, there are 30 analyzed for placebo only and 30 analyzed for drug only.'}, {'type': 'SECONDARY', 'title': 'Mean Differences in AgRP Concentrations (pg/ml) in CSF After Lorcaserin for One Week Compared to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Phase 1: These participants either received placebo before the washout OR crossed over after washout to receive placebo twice a day for 7 days.\n\nPlacebo: The placebo is made to mimic Belviq, but does not contain any active drug.'}, {'id': 'OG001', 'title': 'Lorcaserin', 'description': 'Phase 1: These participants received lorcaserin (Belviq) 10 mg before the washout OR crossed over after the washout to receive lorcaserin twice a day for 7 days.\n\nBelviq: Belviq is an oral drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.9', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '24.2', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, up to 5 weeks', 'description': 'This is designed to measure mean mean Agouti-related protein (AgRP) concentrations (pg/ml) in CSF in blood in order to determine if long-term lorcaserin induced weight loss can be predicted by short-term differences in AgRP concentrations.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The data information were collected and analyzed separately for the time period of placebo or drug exposure - i.e., comparing participants receiving placebo only OR Lorcaserin only (instead of comparing Arm A and Arm B). At one point, the same participant was exposed to either placebo OR Lorcaserin. Therefore, there are 30 analyzed for placebo only and 30 analyzed for drug only.'}, {'type': 'SECONDARY', 'title': 'Mean Differences in AgRP Concentrations (Fmol/ml) in Blood After Lorcaserin for One Week Compared to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Phase 1: These participants either received placebo before the washout OR crossed over after washout to receive placebo twice a day for 7 days.\n\nPlacebo: The placebo is made to mimic Belviq, but does not contain any active drug.'}, {'id': 'OG001', 'title': 'Lorcaserin', 'description': 'Phase 1: These participants received lorcaserin (Belviq) 10 mg before the washout OR crossed over after the washout to receive lorcaserin twice a day for 7 days.\n\nBelviq: Belviq is an oral drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.7', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '79.2', 'spread': '7.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, up to 5 weeks', 'description': 'This is designed to measure mean Agouti-related protein (AgRP) concentrations (fmol/ml) in blood in order to determine if long-term lorcaserin induced weight loss can be predicted by short-term differences in AgRP concentrations.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The data information were collected and analyzed separately for the time period of placebo or drug exposure - i.e., comparing participants receiving placebo only OR Lorcaserin only (instead of comparing Arm A and Arm B). At one point, the same participant was exposed to either placebo OR Lorcaserin. Therefore, there are 30 analyzed for placebo only and 30 analyzed for drug only.'}, {'type': 'SECONDARY', 'title': 'Mean Differences in Cortisol Concentrations (ng/ml) in CSF After Lorcaserin for One Week Compared to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Phase 1: These participants either received placebo before the washout OR crossed over after washout to receive placebo twice a day for 7 days.\n\nPlacebo: The placebo is made to mimic Belviq, but does not contain any active drug.'}, {'id': 'OG001', 'title': 'Lorcaserin', 'description': 'Phase 1: These participants received lorcaserin (Belviq) 10 mg before the washout OR crossed over after the washout to receive lorcaserin twice a day for 7 days.\n\nBelviq: Belviq is an oral drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '6.08', 'spread': '0.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, up to 5 weeks', 'description': 'This is designed to measure mean Cortisol concentrations (ng/ml) in CSF in order to determine if long-term lorcaserin induced weight loss can be predicted by short-term differences in cortisol concentrations.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The data information were collected and analyzed separately for the time period of placebo or drug exposure - i.e., comparing participants receiving placebo only OR Lorcaserin only (instead of comparing Arm A and Arm B). At one point, the same participant was exposed to either placebo OR Lorcaserin. Therefore, there are 30 analyzed for placebo only and 30 analyzed for drug only.'}, {'type': 'SECONDARY', 'title': 'Insulin Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Phase 1: These participants either received placebo before the washout OR crossed over after washout to receive placebo twice a day for 7 days.\n\nPlacebo: The placebo is made to mimic Belviq, but does not contain any active drug.'}, {'id': 'OG001', 'title': 'Lorcaserin', 'description': 'Phase 1: These participants received lorcaserin (Belviq) 10 mg before the washout OR crossed over after the washout to receive lorcaserin twice a day for 7 days.\n\nBelviq: Belviq is an oral drug.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.1', 'spread': '3.27', 'groupId': 'OG000'}, {'value': '13.2', 'spread': '1.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0189', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Changes in fasting serum insulin after 1 week of lorcaserin compared to placebo.', 'description': 'This is designed to determine effects of lorcaserin on glucose homeostasis by measuring changes in insulin levels after 1 week of lorcaserin versus placebo.', 'unitOfMeasure': 'µIU/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The data information were collected and analyzed separately for the time period of placebo or drug exposure - i.e., comparing participants receiving placebo only OR Lorcaserin only (instead of comparing Arm A and Arm B). At one point, the same participant was exposed to either placebo OR Lorcaserin. Therefore, there are 30 analyzed for placebo only and 30 analyzed for drug only.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A (LOR-Placebo-LOR)', 'description': 'Phase 1: Participants receive lorcaserin (Belviq) 10 mg twice a day for 7 days followed by a 3 week washout period. These participants will then be crossed over to receive placebo twice a day for 7 days.\n\nPhase 2: Participants will receive additional lorcaserin (Belviq) for 24 weeks.\n\nBelviq: Belviq is an oral drug. Placebo: The placebo is made to mimic Belviq, but does not contain any active drug.'}, {'id': 'FG001', 'title': 'Arm B (Placebo-LOR-LOR)', 'description': 'Phase 1: Participants receive placebo twice a day for 7 days followed by a 3 week washout period. These participants will then be crossed over to receive lorcaserin (Belviq) 10 mg twice a day for 7 days.\n\nPhase 2: Participants will receive additional lorcaserin (Belviq) for 24 weeks.\n\nBelviq: Belviq is an oral drug. Placebo: The placebo is made to mimic Belviq, but does not contain any active drug.'}], 'periods': [{'title': 'First Intervention (7 Days) - Phase 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout (3 Weeks) - Phase 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (7 Days) - Phase 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Third Intervention (6 Months) - Phase 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Study was stopped due to unavailable study drug supply', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'preAssignmentDetails': 'Out of the 32 enrolled subjects: 30 subjects completed Phase 1 (Arms A and B) and 30 subjects continued into Phase 2. However, the study was stopped prematurely during Phase 2 as lorcaserin was withdrawn from the market. Data was collected and analyzed for the 30 subjects that completed phase 1 out of 32 subjects; the 2 subjects who did not complete phase 1 were excluded from analysis. 19 subjects completed phase 2.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A+B (All Participants)', 'description': 'Phase 1: Participants either receive lorcaserin (Belviq) 10 mg twice a day for 7 days followed by a 3 week washout period then cross over to receive placebo twice a day for 7 days (Arm A) OR receive placebo twice a day for 7 days followed by a 3 week washout period then cross over to receive lorcaserin (Belviq) 10 mg twice a day for 7 days (Arm B).\n\nPhase 2: Participants (from both arms) will receive additional lorcaserin (Belviq) for 24 weeks.\n\nBelviq: Belviq is an oral drug. Placebo: The placebo is made to mimic Belviq, but does not contain any active drug.\n\nBelviq: Belviq is an oral drug\n\nPlacebo: The placebo is made to mimic Belviq, but does not contain any active drug'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-29', 'size': 878626, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-29T13:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'whyStopped': 'The FDA advised of a possible health risk associated with lorcaserin and the drug is being withdrawn.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2020-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-25', 'studyFirstSubmitDate': '2017-11-21', 'resultsFirstSubmitDate': '2021-05-05', 'studyFirstSubmitQcDate': '2017-11-21', 'lastUpdatePostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-29', 'studyFirstPostDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Differences in Food Intake During a Laboratory Test Meal After Lorcaserin for One Week Compared to Placebo', 'timeFrame': 'First test meal and follow-up test meal (approximately up to 5 weeks)', 'description': 'This is designed to measure food Intake (average calories consumed during test meal), in order to determine if long-term lorcaserin induced weight loss is predicted by the short-term differences in calories consumed during the test meal.'}, {'measure': 'Mean Differences in POMC Concentrations (Fmol/ml) in CSF After Lorcaserin for One Week Compared to Placebo', 'timeFrame': 'Baseline, up to 5 weeks', 'description': 'This is designed to measure mean CSF proopiomelanocortin (POMC) concentrations (fmol/ml), in order to determine if long-term lorcaserin induced weight loss can be predicted by differences in CSF POMC concentrations.'}], 'secondaryOutcomes': [{'measure': 'CSF Concentrations of ß-endorphin', 'timeFrame': 'Baseline, up to 5 weeks', 'description': 'Mean differences in levels of ß-endorphin, a POMC-derived peptide, in CSF after lorcaserin for one week compared to placebo in order to determine if long-term lorcaserin induced weight loss can be predicted using short-term differences in CSF concentrations of ß-endorphin.'}, {'measure': 'Mean Differences in AgRP Concentrations (pg/ml) in CSF After Lorcaserin for One Week Compared to Placebo', 'timeFrame': 'Baseline, up to 5 weeks', 'description': 'This is designed to measure mean mean Agouti-related protein (AgRP) concentrations (pg/ml) in CSF in blood in order to determine if long-term lorcaserin induced weight loss can be predicted by short-term differences in AgRP concentrations.'}, {'measure': 'Mean Differences in AgRP Concentrations (Fmol/ml) in Blood After Lorcaserin for One Week Compared to Placebo', 'timeFrame': 'Baseline, up to 5 weeks', 'description': 'This is designed to measure mean Agouti-related protein (AgRP) concentrations (fmol/ml) in blood in order to determine if long-term lorcaserin induced weight loss can be predicted by short-term differences in AgRP concentrations.'}, {'measure': 'Mean Differences in Cortisol Concentrations (ng/ml) in CSF After Lorcaserin for One Week Compared to Placebo', 'timeFrame': 'Baseline, up to 5 weeks', 'description': 'This is designed to measure mean Cortisol concentrations (ng/ml) in CSF in order to determine if long-term lorcaserin induced weight loss can be predicted by short-term differences in cortisol concentrations.'}, {'measure': 'Insulin Level', 'timeFrame': 'Changes in fasting serum insulin after 1 week of lorcaserin compared to placebo.', 'description': 'This is designed to determine effects of lorcaserin on glucose homeostasis by measuring changes in insulin levels after 1 week of lorcaserin versus placebo.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Overweight', 'Obesity', 'Weight Loss', 'Lorcaserin', 'Healthy Volunteers'], 'conditions': ['Overweight and Obesity']}, 'referencesModule': {'references': [{'pmid': '36897161', 'type': 'RESULT', 'citation': 'Sideri Gugger A, Dimino C, Panigrahi SK, Mayer L, Smiley RM, Korner J, Wardlaw SL. Defining Predictors of Weight Loss Response to Lorcaserin. J Clin Endocrinol Metab. 2023 Aug 18;108(9):2262-2271. doi: 10.1210/clinem/dgad139.'}], 'seeAlsoLinks': [{'url': 'https://druginfo.nlm.nih.gov/drugportal/name/lorcaserin%20hcl', 'label': 'NIH - lorcaserin HCl'}, {'url': 'https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022529', 'label': 'FDA approval Belviq'}]}, 'descriptionModule': {'briefSummary': 'This two-phase study aims to explore ways to predict who will respond well to the weight loss drug lorcaserin and to understand the mechanisms that develop which limit drug efficacy. Subjects will be recruited for a 5-week crossover study (phase 1) with lorcaserin and placebo followed by treatment with lorcaserin for 24 weeks (phase 2).', 'detailedDescription': 'In phase 1, at Weeks 1 and 5, participants will take the weight loss drug lorcaserin or placebo for 7 days. At Week 5 participants will receive whichever treatment they did not receive at Week 1. At the end of Weeks 1 and 5, participants will have a lumbar puncture (spinal tap) to collect cerebrospinal fluid (CSF) for neuropeptide and hormone analyses, including proopiomelanocortin (POMC), Agouti-related protein (AgRP) and cortisol. Blood will also be obtained for neuropeptide and hormone analyses. Breakfast will be served to participants who will then complete an eating behavior profile. A laboratory test meal will be performed 4h after breakfast.\n\nAfter completing both the 7 day lorcaserin and placebo studies, participants will then continue on Phase 2 of the study, which includes treatment with lorcaserin for 24 weeks. Subjects will receive nutritional counseling to reduce their daily caloric intake to 600 kcal below their calculated caloric requirement and will be encourage to exercise moderately for 30 minutes daily. Participants will visit the clinic monthly during the 24 week study period for nutritional counseling, review of food diaries, vital signs and safely labs. Blood will also be obtained for neuropeptide peptide and hormone analyses. At the end of the 24 week period subjects will come for a final study visit, including a lumbar puncture, blood sample, breakfast, an eating behavior profile and a test meal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (BMI) 28-40\n\nExclusion Criteria:\n\n* Any clinically significant or relevant medical condition, including:\n* Diabetes\n* Uncontrolled Hypertension\n* Heart disease\n* Bleeding disorder\n* Kidney or liver dysfunction\n* Neurologic disease\n* Psychiatric or eating disorders\n* Pregnancy or breastfeeding\n* Use of tobacco or opiates\n* History of alcohol or drug abuse\n* Recent weight change +/- 5%\n* Medications that affect body weight'}, 'identificationModule': {'nctId': 'NCT03353220', 'briefTitle': 'Predictors of Lorcaserin-Induced Weight Loss', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Central Mechanisms and Predictors of Lorcaserin-Induced Weight Loss', 'orgStudyIdInfo': {'id': 'AAAR1622'}, 'secondaryIdInfos': [{'id': '2R01DK093920', 'link': 'https://reporter.nih.gov/quickSearch/2R01DK093920', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'Participants receive lorcaserin (Belviq) 10 mg twice a day for 7 days followed by a 3 week washout period. These participants will then be crossed over to receive placebo twice a day for 7 days.', 'interventionNames': ['Drug: Belviq', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'description': 'Participants receive placebo twice a day for 7 days followed by a 3 week washout period. These participants will then be crossed over to receive lorcaserin (Belviq)10 mg twice a day for 7 days.', 'interventionNames': ['Drug: Belviq', 'Drug: Placebo']}], 'interventions': [{'name': 'Belviq', 'type': 'DRUG', 'otherNames': ['Lorcaserin'], 'description': 'Belviq is an oral drug', 'armGroupLabels': ['Arm A', 'Arm B']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The placebo is made to mimic Belviq, but does not contain any active drug', 'armGroupLabels': ['Arm A', 'Arm B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Sharon Wardlaw, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'New York State Psychiatric Institute', 'class': 'OTHER'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Sharon Wardlaw', 'investigatorAffiliation': 'Columbia University'}}}}