Ignite Creation Date:
2025-12-24 @ 6:46 PM
Ignite Modification Date:
2025-12-31 @ 8:49 AM
Study NCT ID:
NCT05445557
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2022-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Safety and Efficacy of RZL-012 in Subjects Seeking Fat Reduction in the Flanks
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C000720429', 'term': 'RZL-012'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'racheli@raziel-therapy.com', 'phone': '97289124670', 'title': 'Racheli Gueta, Director of Clinical Trials', 'organization': 'Raziel Therapeutics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks Double blind phase and 12 weeks open label phase', 'eventGroups': [{'id': 'EG000', 'title': 'RZL-012 50mg/ml', 'description': 'Subjects flanks treated with RZL-012 (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal doses 412.5 mg. Each injection point will be dosed with 7.5 mg for in a volume of 0.15 mL/injection site.\n\nRZL-012: small synthetic molecule for submental fat reduction', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Subjects flanks treated with placebo (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal volume of 8.25mL. Each injection point will be dosed with 0.15 mL/injection site.\n\nPlacebo: Placebo', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'edema', 'notes': 'GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pain', 'notes': 'GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'tenderness', 'notes': 'GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'edema Open Label phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pain open label phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tenderness - Open Label phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoesthesia Open Label phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema open label phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus Open Label phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Hyperpigmentation open label phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin irritation Open Label phase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-related Adverse Events [AEs]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RZL-012 50mg/ml', 'description': 'Subjects flanks treated with RZL-012 (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal doses 412.5 mg. Each injection point will be dosed with 7.5 mg for in a volume of 0.15 mL/injection site.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects flanks treated with placebo (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal volume of 8.25mL. Each injection point will be dosed with 0.15 mL/injection site.\n\nPlacebo: Placebo\n\nRZL-012: small synthetic molecule for submental fat reduction'}, {'id': 'OG002', 'title': 'RZL-012 Open Label', 'description': 'Subjects that were treated with placebo in their flanks chose to treat these flanks with RZL-012'}], 'classes': [{'title': 'AE Related Study Treatment', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Related to Injection Procedure', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Severe Adverse Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase', 'description': 'Safety', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The data for double blind and open label phase are presented. A total of 9 subjects continued to open label phase.'}, {'type': 'SECONDARY', 'title': 'Efficacy - Number of Flanks That Have Change in Score According Physician Global Assessment Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}, {'units': 'Flanks', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RZL-012 50mg/ml Double Blind', 'description': 'Subjects flanks treated with RZL-012 (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal doses 412.5 mg. Each injection point will be dosed with 7.5 mg for in a volume of 0.15 mL/injection site.\n\nRZL-012: small synthetic molecule for submental fat reduction'}, {'id': 'OG001', 'title': 'Placebo Double Blind', 'description': 'Subjects flanks treated with PLACEBO (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 . Each injection point will be dosed with of 0.15 mL/injection site.\n\nPlacebo: Vehicle of drug product'}, {'id': 'OG002', 'title': 'RZL-012 Open Label Treatment', 'description': 'Subjects flanks treated with RZL-012 (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal doses 412.5 mg. Each injection point will be dosed with 7.5 mg for in a volume of 0.15 mL/injection site.'}], 'classes': [{'title': 'Marked Improvement', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Moderate Improvement', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Slight Improvement', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase', 'description': 'To compare the proportion of flanks having an improvement as indicated by reduction in score from 6 to 0 according to the Physician Global Assessment Scale (GAIS) in RZL-01-treated flanks vs placebo-treated flanks', 'unitOfMeasure': 'flanks', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Flanks', 'denomUnitsSelected': 'Flanks', 'populationDescription': 'A total of 9 subjects continued to the open label phase'}, {'type': 'SECONDARY', 'title': 'Efficacy - Change in Satisfaction Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RZL-012 50mg/ml or Placebo', 'description': 'Subjects flanks treated with RZL-012 (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal doses 412.5 mg. Each injection point will be dosed with 7.5 mg for in a volume of 0.15 mL/injection site.\n\nSubjects flanks treated with placebo (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal volume of 8.25mL. Each injection point will be dosed with 0.15 mL/injection site.\n\nPlacebo: Placebo\n\nRZL-012: small synthetic molecule for submental fat reduction'}], 'classes': [{'title': 'RZL-012 - Double blind phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Satisfied', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Not Satisfied', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Placebo Double blind phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Satisfied', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Not Satisfied', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'RZL-012 Open Label phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Satisfied', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Not Satisfied', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase', 'description': 'To compare the proportion of subjects who are satisfied with treatment results as indicated by a binary yes/no satisfaction questionnaire in RZL-012-treated flanks vs placebo-treated flanks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9subjects continued to the open label phase'}, {'type': 'SECONDARY', 'title': 'Efficacy - Relative Change in Measured Fat Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}, {'units': 'Flanks', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RZL-012 50mg/ml Double Blind Part', 'description': 'Subjects flanks treated with RZL-012 (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal doses 412.5 mg. Each injection point will be dosed with 7.5 mg for in a volume of 0.15 mL/injection site.\n\nRZL-012: small synthetic molecule for submental fat reduction'}, {'id': 'OG001', 'title': 'Placebo Double Blind Part', 'description': 'Subjects flanks treated with placebo (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal volume of 8.25mL. Each injection point will be dosed with 0.15 mL/injection site.\n\nPlacebo: Placebo'}, {'id': 'OG002', 'title': 'RZL-012 Open Label Part', 'description': 'Subjects flanks treated with RZL-012 (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal doses 412.5 mg. Each injection point will be dosed with 7.5 mg for in a volume of 0.15 mL/injection site.\n\nRZL-012: small synthetic molecule for submental fat reduction'}], 'classes': [{'categories': [{'measurements': [{'value': '-37', 'spread': '55.2', 'groupId': 'OG000'}, {'value': '33', 'spread': '41.4', 'groupId': 'OG001'}, {'value': '-48.9', 'spread': '65.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase. Baseline for the open-label phase considered to be 12 weeks after double blind treatment', 'description': 'Measure the relative mean reduction in volume (%) at post treatment vs. baseline for each of the treated flanks, as measured by 3D images using the Canfield 3D system in RZL-012-treated flanks vs placebo-treated flanks at 12 weeks vs. baseline', 'unitOfMeasure': 'percentage of change from baseline.', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Flanks', 'denomUnitsSelected': 'Flanks', 'populationDescription': 'A total of 9 subjects continued to the open label phase'}, {'type': 'SECONDARY', 'title': 'Efficacy -Number of Participant With Correct Identification by Reviewers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RZL-012 50mg/ml', 'description': 'Subjects flanks treated with RZL-012 (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal doses 412.5 mg. Each injection point will be dosed with 7.5 mg for in a volume of 0.15 mL/injection site.\n\nRZL-012: small synthetic molecule for submental fat reduction'}], 'classes': [{'categories': [{'title': 'Reviewer 1 - Correct identification of active treated flanks', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Reviewer 2 - Correct identification of active treated flanks', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks 12 weeks for the Double-Blind Phase', 'description': 'Blinded reviewers will identify, per patient, the flank treated with test compound (active) vs the flank treated with Placebo. Success will be defined as at least 70% correct identification vs the expected 50% correct identification based on random guessing', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics Measure - Drug Concentration in the Blood (ng/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RZL-012 50mg/ml', 'description': 'Subjects flanks treated with RZL-012 (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal doses 412.5 mg. Each injection point will be dosed with 7.5 mg for in a volume of 0.15 mL/injection site.\n\nRZL-012: small synthetic molecule for submental fat reduction'}], 'classes': [{'categories': [{'measurements': [{'value': '961.8', 'spread': '273.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 hours', 'description': 'Measurement of maximum drug concentration (Cmax) (ng/mL) in the blood', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': 'Subjects flanks treated with RZL-012 (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal doses 412.5 mg. Each injection point will be dosed with 7.5 mg for in a volume of 0.15 mL/injection site.\n\nRZL-012: small synthetic molecule for submental fat reduction'}], 'periods': [{'title': 'Double Blind Part', 'milestones': [{'type': 'STARTED', 'comment': 'RZL-012', 'achievements': [{'groupId': 'FG000', 'numUnits': '24', 'numSubjects': '12'}]}, {'type': 'Flanks Treated With RZL-012', 'achievements': [{'groupId': 'FG000', 'numUnits': '12', 'numSubjects': '12'}]}, {'type': 'Flanks Treated With Placebo', 'achievements': [{'groupId': 'FG000', 'numUnits': '12', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '22', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Open Label - Active Only', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '9', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '9', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'flanks'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'RZL-012 50mg/ml or Placebo', 'description': 'Subjects flanks treated with RZL-012 (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal doses 412.5 mg. Each injection point will be dosed with 7.5 mg for in a volume of 0.15 mL/injection site.\n\nRZL-012: small synthetic molecule for submental fat reduction\n\nSubjects flanks treated with placebo (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal volume of 8.25mL. Each injection point will be dosed with 0.15 mL/injection site.\n\nPlacebo: Placebo'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Double blind phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '43', 'spread': '12.2', 'groupId': 'BG000'}]}]}, {'title': 'Open Label phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '44.1', 'spread': '10.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The results from the double blind phase and open label phase are presented. The number of subjects that continued to the open label phase were 9.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Double blind phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Open Label phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The results from the double blind phase are presented together with the results from the open label phase.\n\nOnly 9 subjects continued to the open label phase'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Double Blind phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Open label phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'he results from the double blind phase are presented together with the results from the open label phase.\n\nOnly 9 subjects continued to the open label phase'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-30', 'size': 830554, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-24T06:22', 'hasProtocol': True}, {'date': '2022-06-01', 'size': 894800, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-24T06:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "Each of the subject's flanks will be randomized for RZL-012 and placebo injections."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-30', 'studyFirstSubmitDate': '2022-02-14', 'resultsFirstSubmitDate': '2023-06-26', 'studyFirstSubmitQcDate': '2022-07-05', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-30', 'studyFirstPostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-related Adverse Events [AEs]', 'timeFrame': '12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase', 'description': 'Safety'}], 'secondaryOutcomes': [{'measure': 'Efficacy - Number of Flanks That Have Change in Score According Physician Global Assessment Scale', 'timeFrame': '12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase', 'description': 'To compare the proportion of flanks having an improvement as indicated by reduction in score from 6 to 0 according to the Physician Global Assessment Scale (GAIS) in RZL-01-treated flanks vs placebo-treated flanks'}, {'measure': 'Efficacy - Change in Satisfaction Score', 'timeFrame': '12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase', 'description': 'To compare the proportion of subjects who are satisfied with treatment results as indicated by a binary yes/no satisfaction questionnaire in RZL-012-treated flanks vs placebo-treated flanks'}, {'measure': 'Efficacy - Relative Change in Measured Fat Volume', 'timeFrame': '12 weeks for the Double-Blind Phase and 12 weeks for the Open-Label Phase. Baseline for the open-label phase considered to be 12 weeks after double blind treatment', 'description': 'Measure the relative mean reduction in volume (%) at post treatment vs. baseline for each of the treated flanks, as measured by 3D images using the Canfield 3D system in RZL-012-treated flanks vs placebo-treated flanks at 12 weeks vs. baseline'}, {'measure': 'Efficacy -Number of Participant With Correct Identification by Reviewers', 'timeFrame': '12 weeks 12 weeks for the Double-Blind Phase', 'description': 'Blinded reviewers will identify, per patient, the flank treated with test compound (active) vs the flank treated with Placebo. Success will be defined as at least 70% correct identification vs the expected 50% correct identification based on random guessing'}, {'measure': 'Pharmacokinetics Measure - Drug Concentration in the Blood (ng/mL)', 'timeFrame': '30 hours', 'description': 'Measurement of maximum drug concentration (Cmax) (ng/mL) in the blood'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Flank Mass']}, 'descriptionModule': {'briefSummary': "A total of 12 subjects will be injected with RZL-012 and placebo. Each of the subject's flanks will be randomized for each of the treatment. A total of 24 flanks will be randomized in the double blind phase. They will be monitored for safety and efficacy for 12 weeks. After codes opening, a second treatment cycle on the previously untreated contralateral flank will be done. Subjects will be monitored for safety and efficacy for additional 12 weeks.", 'detailedDescription': 'This clinical trial is comprised of a double-blind, placebo-controlled phase followed by an open-label phase.\n\nThe double-blind, placebo-controlled phase of the trial will consist of a screening period, baseline visit and a 12-week post-treatment follow-up period. At the baseline visit, each flank (right and left) of each study participant will be randomized into either the active RZL-012 treatment group or the placebo group and each flank will receive multiple injections in a single session of RZL-012 or placebo. Blood samples will be collected for 6 of the 12 subjects for PK analyses. All subjects will be followed up for 12 weeks after the single treatment session.\n\nUpon completion of the double-blind phase of the study, and the opening of codes subjects will be offered RZL-012 open-label treatment in the flank previously treated with placebo. Consenting subjects will be followed for safety and efficacy for an additional 12 weeks.\n\nIn both the double-blind and open-label phases of the study, subjects will be monitored for adverse events (AEs). Subjects will return to the site for visits at 1 week, 4 weeks, 8 weeks, and 12 weeks post treatment and will be monitored for safety and efficacy during these visits.\n\nSubjects who will be collected with PK will return to the clinic at Day 1 post injection for further PK samples.\n\nThe dimensions of flanks will be measured using 3D images and volumetric calculations using Canfield 3D images.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Is a male or female subject between the ages of 18 and 65 years, inclusive.\n* Has body mass index (BMI) BMI of ≥ 22 and \\< 30.\n* Has clearly visible and palpable fat in the flanks\n* Has symmetrical appearance of right and left flanks\n* Agrees to maintain weight (i.e., within 5% of body weight) by not making any changes in diet.\n* Agree to avoid exposure of the treated area to the sun for at least 1 month after each treatment session.\n* If female, is not pregnant or breastfeeding based on the following:\n\n 1. agree to the use of highly effective contraceptive methods for at least 2 weeks before baseline until 28 days after the last day of study drug and a negative urine pregnancy test at screening and baseline; or\n 2. is of nonchildbearing potential defined as clinically infertile as the result of surgical sterilization (hysterectomy, bilateral tubal ligation, and/or bilateral oophorectomy); or\n 3. is confirmed postmenopausal status (defined as either having amenorrhea for ≥ 12 consecutive months without another cause, having documented serum follicle-stimulating hormone (FSH) level \\> 40 mIU/mL, or having another documented medical condition (e.g., was born without a uterus))\n* If male (with or without vasectomy), agree to the use of highly effective contraceptive methods, e.g. condom, from study baseline until 7 days after the last day of study drug.\n* Is willing to avoid strenuous exercise for seven (7) days post treatment.\n* Is motivated to adhere to the visit schedule and protocol requirements.\n* Is willing and able to sign an Institutional Review Board (IRB) approved informed consent form (ICF) indicating that they are aware of the investigational nature of the study.\n\nExclusion Criteria:\n\n* Is unable to tolerate subcutaneous injections.\n* Has dysfunctional gallbladder activity (e.g., underwent cholecystectomy or cholecystitis).\n* Has an uncontrolled systemic disease that is not stabilized (i.e., cardiovascular disease, mental illness).\n* Has used anticoagulation therapies that may increase bleeding or bruising (i.e., aspirin, ibuprofen, vitamins, and herbal preparations) for seven (7) days prior to treatment.\n* Has medication or a history of coagulopathy.\n* Has a history or family history of venous thrombotic disease.\n* Had a non-invasive fat reduction and/or body contouring procedure in the flanks within the past 12 months.\n* Has any scars, unshaven hair, tattoos, on or near the proposed treatment area.\n* Has significant history or current evidence of a medical, psychological or other disorder that, in the Investigator's opinion, would preclude enrollment in the study.\n* Has an active dermatitis or open wound in the proposed treatment area.\n* Abnormal coagulation profile including: activated partial thromboplastin time (aPTT) \\> ULN, international normalized ratio (INR) \\> ULN reference range (\\> 1.3), prothrombin time (PT) \\> ULN.\n* Has an active bacterial, fungal, or viral infection in the proposed treatment area.\n* Has known allergic reactions to any injectables.\n* Has been treated chronically in the past 3 months prior to study entry with systemic steroids or immunosuppressive drugs.\n* Has been treated chronically at least one (1) week prior to study entry with non-steroidal anti-inflammatory drugs (NSAIDs).\n* Current participation or participation within three (3) months prior to the start of this study in a drug or other investigational research study"}, 'identificationModule': {'nctId': 'NCT05445557', 'briefTitle': 'Evaluation of Safety and Efficacy of RZL-012 in Subjects Seeking Fat Reduction in the Flanks', 'organization': {'class': 'INDUSTRY', 'fullName': 'Raziel Therapeutics Ltd.'}, 'officialTitle': 'A Double-Blind, Placebo-Controlled Phase Followed by An Open-Label Phase to Evaluate the Safety and Efficacy of RZL-012 in Subjects Seeking Fat Reduction in the Flanks', 'orgStudyIdInfo': {'id': 'RZL-012-FL-P2US-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RZL-012 50mg/ml', 'description': 'Subjects flanks treated with RZL-012 (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal doses 412.5 mg. Each injection point will be dosed with 7.5 mg for in a volume of 0.15 mL/injection site.', 'interventionNames': ['Drug: RZL-012']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects flanks treated with placebo (in the double blind phase) will undergo a single treatment session with 50-55 injections. The maximal number of injections will be 55 with maximal volume of 8.25mL. Each injection point will be dosed with 0.15 mL/injection site.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'RZL-012', 'type': 'DRUG', 'description': 'small synthetic molecule for submental fat reduction', 'armGroupLabels': ['RZL-012 50mg/ml']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Luxurgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Raziel Therapeutics Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}