Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-03-06 @ 5:42 AM
Study NCT ID:
NCT02163902
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2014-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long-term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Bowen_Beta@allergan.com', 'phone': '714-246-4446', 'title': 'Beta Bowen', 'organization': 'Allergan, Inc'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first exposure to study drug in predecessor study to up to 36 months after last treatment in predecessor study', 'description': 'All enrolled participants with a clearly identifiable actual treatment received from a previous ATX-101 study and at least 1 visit in the long-term follow-up (LTFU) study were included in the analysis population. All adverse events (AEs) and serious adverse events (SAEs) that were ongoing at the conclusion of the predecessor Studies ATX-101-11-22 and ATX-101-11-23 were followed until they resolved or were considered medically stable.', 'eventGroups': [{'id': 'EG000', 'title': 'ATX-101 (Deoxycholic Acid) Injection', 'description': 'This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 2 predecessor studies ATX-101-11-22 and ATX-101-11-23.', 'otherNumAtRisk': 113, 'deathsNumAtRisk': 113, 'otherNumAffected': 0, 'seriousNumAtRisk': 113, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Placebo', 'description': 'This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 2 predecessor studies ATX-101- 11-22 and ATX-101-11-23.', 'otherNumAtRisk': 111, 'deathsNumAtRisk': 111, 'otherNumAffected': 0, 'seriousNumAtRisk': 111, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Small cell lung cancer stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 113, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 111, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Breast reconstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Ovarian cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Breast cancer in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATX-101 (Deoxycholic Acid) Injection', 'description': 'This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 2 predecessor studies ATX-101-11-22 and ATX-101-11-23.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 2 predecessor studies ATX-101- 11-22 and ATX-101-11-23.'}], 'classes': [{'title': 'Visit 1 (Year 1) Percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.4', 'groupId': 'OG000', 'lowerLimit': '79.2', 'upperLimit': '93.5'}, {'value': '56.8', 'groupId': 'OG001', 'lowerLimit': '42.2', 'upperLimit': '71.5'}]}]}, {'title': 'Visit 2 (Year 2) Percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.6', 'groupId': 'OG000', 'lowerLimit': '84.4', 'upperLimit': '96.8'}, {'value': '73.8', 'groupId': 'OG001', 'lowerLimit': '60.5', 'upperLimit': '87.1'}]}]}, {'title': 'Visit 3 (Year 3) Percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.4', 'groupId': 'OG000', 'lowerLimit': '74.2', 'upperLimit': '90.5'}, {'value': '65.0', 'groupId': 'OG001', 'lowerLimit': '50.2', 'upperLimit': '79.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment', 'description': "The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).\n\nNon-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had at least a 1-grade reduction from baseline on the CRSMFRS (ie, CR-1 responder) at 12-weeks after last treatment in the predecessor studies.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Maintaining CR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATX-101 (Deoxycholic Acid) Injection', 'description': 'This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 2 predecessor studies ATX-101-11-22 and ATX-101-11-23.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 2 predecessor studies ATX-101- 11-22 and ATX-101-11-23.'}], 'classes': [{'title': 'Visit 1 (Year 1) Percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '61.6', 'upperLimit': '88.4'}, {'value': '18.2', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '41.0'}]}]}, {'title': 'Visit 2 (Year 2) Percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.5', 'groupId': 'OG000', 'lowerLimit': '58.7', 'upperLimit': '86.3'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '64.1'}]}]}, {'title': 'Visit 3 (Year 3) Percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.8', 'groupId': 'OG000', 'lowerLimit': '50.7', 'upperLimit': '80.9'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '64.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment.', 'description': "The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).\n\nNon-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis Population: Participants who had at least a 2-grade reduction from baseline on the CR-SMFRS (ie, CR-2 responder) at 12-weeks after last treatment in the predecessor studies.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATX-101 (Deoxycholic Acid) Injection', 'description': 'This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 2 predecessor studies ATX-101-11-22 and ATX-101-11-23.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 2 predecessor studies ATX-101- 11-22 and ATX-101-11-23.'}], 'classes': [{'title': 'Visit 1 (Year 1) Percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.5', 'groupId': 'OG000', 'lowerLimit': '91.1', 'upperLimit': '99.8'}, {'value': '76.4', 'groupId': 'OG001', 'lowerLimit': '65.1', 'upperLimit': '87.6'}]}]}, {'title': 'Visit 2 (Year 2) Percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.8', 'groupId': 'OG000', 'lowerLimit': '81.0', 'upperLimit': '94.5'}, {'value': '83.0', 'groupId': 'OG001', 'lowerLimit': '72.9', 'upperLimit': '93.1'}]}]}, {'title': 'Visit 3 (Year 3) Percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.0', 'groupId': 'OG000', 'lowerLimit': '68.2', 'upperLimit': '85.9'}, {'value': '75.0', 'groupId': 'OG001', 'lowerLimit': '62.8', 'upperLimit': '87.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment', 'description': 'The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).\n\nNon-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis Population: Participants who had at least a 1-grade reduction from baseline in PR-SMFRS (ie, PR-1 responder) at 12-weeks after last treatment in the predecessor studies.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Maintaining PR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATX-101 (Deoxycholic Acid) Injection', 'description': 'This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 2 predecessor studies ATX-101-11-22 and ATX-101-11-23.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 2 predecessor studies ATX-101- 11-22 and ATX-101-11-23.'}], 'classes': [{'title': 'Visit 1 (Year 1) Percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.0', 'groupId': 'OG000', 'lowerLimit': '43.5', 'upperLimit': '74.4'}, {'value': '63.6', 'groupId': 'OG001', 'lowerLimit': '35.2', 'upperLimit': '92.1'}]}]}, {'title': 'Visit 2 (Year 2) Percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.5', 'groupId': 'OG000', 'lowerLimit': '42.2', 'upperLimit': '72.8'}, {'value': '60.0', 'groupId': 'OG001', 'lowerLimit': '29.6', 'upperLimit': '90.4'}]}]}, {'title': 'Visit 3 (Year 3) Percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.5', 'groupId': 'OG000', 'lowerLimit': '43.6', 'upperLimit': '75.3'}, {'value': '70.0', 'groupId': 'OG001', 'lowerLimit': '41.6', 'upperLimit': '98.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment', 'description': 'The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).\n\nNon-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis Population: Participants who had at least a 2-grade reduction from baseline in PR-SMFRS (ie, PR-2 responder) at 12-weeks after last treatment in the predecessor studies.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATX-101 (Deoxycholic Acid) Injection', 'description': 'This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 2 predecessor studies ATX-101-11-22 and ATX-101-11-23.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 2 predecessor studies ATX-101- 11-22 and ATX-101-11-23.'}], 'classes': [{'title': 'Visit 1 (Year 1) Percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.8', 'groupId': 'OG000', 'lowerLimit': '79.2', 'upperLimit': '94.4'}, {'value': '44.8', 'groupId': 'OG001', 'lowerLimit': '26.7', 'upperLimit': '62.9'}]}]}, {'title': 'Visit 2 (Year 2) Percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85.1', 'groupId': 'OG000', 'lowerLimit': '77.0', 'upperLimit': '93.2'}, {'value': '64.3', 'groupId': 'OG001', 'lowerLimit': '46.5', 'upperLimit': '82.0'}]}]}, {'title': 'Visit 3 (Year 3) Percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.6', 'groupId': 'OG000', 'lowerLimit': '62.4', 'upperLimit': '82.8'}, {'value': '46.2', 'groupId': 'OG001', 'lowerLimit': '27.0', 'upperLimit': '65.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment', 'description': "The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).\n\nThe participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).\n\nNon-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis Population: Participants who were both CR-1 responders and PR-1 responders (SMFRS-1) at 12-weeks after last treatment in the predecessor studies.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ATX-101 (Deoxycholic Acid) Injection', 'description': 'This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 2 predecessor studies ATX-101-11-22 and ATX-101-11-23.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 2 predecessor studies ATX-101- 11-22 and ATX-101-11-23.'}], 'classes': [{'title': 'Visit 1 (Year 1) Percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.2', 'groupId': 'OG000', 'lowerLimit': '17.8', 'upperLimit': '64.6'}, {'value': '0.0', 'comment': 'Of the 3 SMFRS-2 responders in the Placebo group 0 participants maintained response.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Visit 2 (Year 2) Percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.8', 'groupId': 'OG000', 'lowerLimit': '19.4', 'upperLimit': '68.1'}, {'value': '0.0', 'comment': 'Of the 3 SMFRS-2 responders in the Placebo group 0 participants maintained response.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Visit 3 (Year 3) Percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '23.8', 'upperLimit': '76.2'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment', 'description': "The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).\n\nThe participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).\n\nNon-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis Population: Participants who were both CR-2 responders and PR-2 responders (SMFRS-2) at 12-weeks after last treatment in the predecessor studies.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ATX-101 (Deoxycholic Acid) Injection', 'description': 'This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 2 predecessor studies ATX-101-11-22 and ATX-101-11-23.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 2 predecessor studies ATX-101- 11-22 and ATX-101-11-23.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '111'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': "Subject's Request", 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Administrative Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'The objective of this non-treatment, double-blind, placebo-controlled follow-up study was to evaluate the long-term efficacy and safety of subcutaneous (SC) injections of deoxycholic acid (ATX-101) in the submental area. No treatment was administered in this study.', 'preAssignmentDetails': 'Participants who previously received deoxycholic acid or placebo injections in studies ATX-101-11-22 and ATX-101-11-23 were enrolled in this non-treatment, double-blind, placebo-controlled follow-up study to further evaluate safety and efficacy.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ATX-101 (Deoxycholic Acid) Injection', 'description': 'This is a non-treatment follow-up study. Participants were previously treated with deoxycholic acid injection, 10 mg/mL in 1 of 2 predecessor studies ATX-101-11-22 and ATX-101-11-23.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'This is a non-treatment follow-up study. Participants were previously treated with placebo in 1 of 2 predecessor studies ATX-101- 11-22 and ATX-101-11-23.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.0', 'spread': '8.22', 'groupId': 'BG000'}, {'value': '50.1', 'spread': '9.00', 'groupId': 'BG001'}, {'value': '50.6', 'spread': '8.61', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '≤ 30 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': '> 30 to ≤ 50 years', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}, {'title': '> 50 years', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}]}, {'title': '< 50 years', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '29.283', 'spread': '4.4934', 'groupId': 'BG000'}, {'value': '28.836', 'spread': '4.0099', 'groupId': 'BG001'}, {'value': '29.062', 'spread': '4.2570', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fitzpatrick Score', 'classes': [{'title': 'I', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'II', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}, {'title': 'III', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}, {'title': 'IV', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}, {'title': 'V', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'VI', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Fitzpatrick skin type is a numerical classification schema for different skin types and tanning abilities. TYPE 1:\n\nPale white skin, blue/hazel eyes, blond/red hair, always burns, never tans. TYPE 2: Fair skin, blue eyes, burns easily, tans poorly. TYPE 3: Darker white skin, tans after initial burn. TYPE 4: Light brown skin, burns minimally, tans easily. TYPE 5: Brown skin, rarely burns, tans darkly easily. TYPE 6: Dark brown or black skin, never burns, always tans darkly.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 224}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-04', 'studyFirstSubmitDate': '2014-06-12', 'resultsFirstSubmitDate': '2020-02-04', 'studyFirstSubmitQcDate': '2014-06-13', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-04', 'studyFirstPostDateStruct': {'date': '2014-06-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits', 'timeFrame': 'From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment', 'description': "The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).\n\nNon-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Maintaining CR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits', 'timeFrame': 'From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment.', 'description': "The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).\n\nNon-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis"}, {'measure': 'Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits', 'timeFrame': 'From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment', 'description': 'The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).\n\nNon-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.'}, {'measure': 'Percentage of Participants Maintaining PR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits', 'timeFrame': 'From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment', 'description': 'The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).\n\nNon-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.'}, {'measure': 'Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits', 'timeFrame': 'From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment', 'description': "The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).\n\nThe participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).\n\nNon-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis."}, {'measure': 'Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits', 'timeFrame': 'From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment', 'description': "The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).\n\nThe participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).\n\nNon-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Submental Fat', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '33617632', 'type': 'DERIVED', 'citation': 'Humphrey S, Cohen JL, Bhatia AC, Green LJ, Green JB, Bowen B. Improvements in Submental Contour up to 3 Years After ATX-101: Efficacy and Safety Follow-Up of the Phase 3 REFINE Trials. Aesthet Surg J. 2021 Oct 15;41(11):NP1532-NP1539. doi: 10.1093/asj/sjab100.'}]}, 'descriptionModule': {'briefSummary': 'The investigation of the long-term safety and maintenance of efficacy of ATX-101 in reduction of submental fat.', 'detailedDescription': 'No study medication is administered in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Any participant who completed follow-up visits at 12 and 24 weeks after the last dose in one of the two predecessor studies\n2. Willingness to comply with the schedule and procedures of this study.\n3. Signed informed consent form (ICF).\n\nExclusion Criteria:\n\n1\\. Participants who have had any treatment or condition (e.g., pregnancy or metabolic disease, which may lead to unstable weight) that may affect assessment of safety or efficacy since enrollment in the predecessor study.'}, 'identificationModule': {'nctId': 'NCT02163902', 'briefTitle': 'Long-term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kythera Biopharmaceuticals'}, 'officialTitle': 'A Multicenter, Double-blind, Nontreatment, Long-term Follow up Study of Subjects Who Completed ATX-101 (Deoxycholic Acid Injection) Clinical Trials ATX-101-11-22 or ATX-101-11-23 for the Reduction of Localized Subcutaneous Fat in the Submental Area', 'orgStudyIdInfo': {'id': 'ATX-101-13-35'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ATX-101', 'description': 'Participants treated with ATX-101 in previous studies ATX-101-11-22 and ATX-101-11-23.', 'interventionNames': ['Drug: ATX-101']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants treated with placebo in previous studies ATX-101-11-22 and ATX-101-11-23.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ATX-101', 'type': 'DRUG', 'description': 'Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events', 'armGroupLabels': ['ATX-101']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Dermatology Cosmetic Laser Medical Associates of La Jolla', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'AboutSkin Dermatology and DermSurgery, PC', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Dermatology Research Institute', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33146', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Stephan Baker MD PA', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33137', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baumann Cosmetic and Research Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Kenneth R. Beer, MD, PA', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '60005', 'city': 'Arlington Hts', 'state': 'Illinois', 'country': 'United States', 'facility': 'Altman Dermatology Associates'}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'DeNova Research', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60563', 'city': 'Naperville', 'state': 'Illinois', 'country': 'United States', 'facility': 'DuPage Medical Group, Dermatology Institute', 'geoPoint': {'lat': 41.78586, 'lon': -88.14729}}, {'zip': '20769', 'city': 'Glendale', 'state': 'Maryland', 'country': 'United States', 'facility': 'Callender Center for Clinical Research', 'geoPoint': {'lat': 39.37983, 'lon': -76.58552}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Aesthetics, Skin Care, Dermatologic Surgery', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '37215', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Clinical Research Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Across America', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': 'V5Z 4E1', 'city': 'Vancouver', 'country': 'Canada', 'facility': 'Shannon Humphrey, MD', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V5Z4E1', 'city': 'Vancouver', 'country': 'Canada', 'facility': 'Carruthers Dermatology Centre Inc.', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Frederick Beddingfield, III, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sponsor GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kythera Biopharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}