Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-24 @ 3:45 PM
Study NCT ID:
NCT03946592
Status:
COMPLETED
Last Update Posted:
2024-04-04
First Post:
2019-05-09
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluate the Efficacy and Safety of DWJ211 in Patient With Moderate or Severe Submental Fat
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-03', 'studyFirstSubmitDate': '2019-05-09', 'studyFirstSubmitQcDate': '2019-05-09', 'lastUpdatePostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PA-SMFRS, SA-SMFRS', 'timeFrame': '12 week after last treatment', 'description': 'Proportion of subject who simultaneously have at least a 1 grade, 2grade improvement from baseline on the PA-SMFRS, SA-SMFRS after the last treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Submental Fat']}, 'descriptionModule': {'briefSummary': 'Evaluate the efficacy and safety of DWJ211 in patient with moderate or severe submental fat', 'detailedDescription': 'DWJ211 is a injectable drug for improvement in the appearance of moderate to severe submental fat (SMF)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Submental fat grade by the investigator as 2 or 3 using the PA-SMFRS and graded by the subject as 2 or 3 using the SA-SMFRS as determined on Visit 1.\n* Dissatisfaction with the submental area expressed by the subject as a rating of 1\\~3 using the SSS as determinded on Visit 1.\n* Less than 35kg/m2 in body mass index on Visit1.\n* Subject who will agree with the no treatment for the procedure that may affect to reduction or the submental fat.\n\nExclusion Criteria:\n\n* History of any intervention to treat SMF\n* History of trauma associated with the chin or neck areas that in the judgement of the investigator may affect evaluation of safety or efficacy of treatment.\n* Evidence of any cause of enlargement in the submental area.\n* History or current symptoms of dysphagia.'}, 'identificationModule': {'nctId': 'NCT03946592', 'acronym': 'SMF', 'briefTitle': 'Evaluate the Efficacy and Safety of DWJ211 in Patient With Moderate or Severe Submental Fat', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'A Randomized, Double-blind, Multi-center, Placebo-controlled, Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of DWJ211 in Patient With Moderate or Severe Submental Fat', 'orgStudyIdInfo': {'id': 'DW_DWJ211301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Inject the Drug into submental fat via subcutaneous', 'interventionNames': ['Drug: Normal saline']}, {'type': 'EXPERIMENTAL', 'label': 'DWJ211 group', 'description': 'Inject the Drug into submental fat via subcutaneous', 'interventionNames': ['Drug: DWJ211']}], 'interventions': [{'name': 'Normal saline', 'type': 'DRUG', 'description': 'Inject the Drug into submental fat via subcutaneous', 'armGroupLabels': ['Placebo group']}, {'name': 'DWJ211', 'type': 'DRUG', 'description': 'Inject the Drug into submental fat via subcutaneous', 'armGroupLabels': ['DWJ211 group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Chung-ang university hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}