Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
Study NCT ID:
NCT05195112
Status:
COMPLETED
Last Update Posted:
2023-02-23
First Post:
2021-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-21', 'studyFirstSubmitDate': '2021-12-13', 'studyFirstSubmitQcDate': '2022-01-12', 'lastUpdatePostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Caliper', 'timeFrame': '4 and 12 weeks', 'description': 'Percentage of change in submental fat thickness as measured by Caliper'}], 'primaryOutcomes': [{'measure': 'Proportion of subjects whose CA-SMFRS (Clinician-Assessed Submental Fat Rating Scale) score changed', 'timeFrame': '12 weeks', 'description': 'Proportion of subjects whose CA-SMFRS decreased 1, 2 points or more compared the 12 weeks after the last administration day to before administration of the IP, Minimum value: 0 (best outcome) / Maximum value: 4 (worst outcome)'}, {'measure': 'Proportion of subjects whose PA-SMFIS (Patient Assessed-Submental Fat Impact Scale) score changed', 'timeFrame': '12 weeks', 'description': 'Proportion of subjects whose PA-MFRS decreased 1, 2 points or more compared the 12 weeks after the last administration day to before administration of the IP , Minimum value: 0 (worst outcome) / Maximum value: 10 (best outcome)'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects whose CA-SMFRS (Clinician-Assessed Submental Fat Rating Scale) score changed', 'timeFrame': '4 weeks', 'description': 'Proportion of subjects whose CA-SMFRS decreased 1, 2 points or more compared the 4 weeks after the last administration day to before administration of the IP, Minimum value: 0 (best outcome) / Maximum value: 4 (worst outcome)'}, {'measure': 'Proportion of subjects whose PA-SMFIS (Patient Assessed-Submental Fat Impact Scale) score changed', 'timeFrame': '4 weeks', 'description': 'Proportion of subjects whose PA-MFRS decreased 1, 2 points or more compared the 4 weeks after the last administration day to before administration of the IP , Minimum value: 0 (worst outcome) / Maximum value: 10 (best outcome)'}, {'measure': 'PA-SMFIS (Patient Assessed-Submental Fat Impact Scale)', 'timeFrame': '4 and 12 weeks', 'description': 'Change PA-SMFIS (Patient Assessed-Submental Fat Impact Scale) score compared 4 to 12 weeks after the last administration of the IP, Minimum value: 0 (worst outcome) / Maximum value: 10 (best outcome)'}, {'measure': 'Measuring submental fat volume by MRI (magnetic resonance imaging)', 'timeFrame': '12 weeks', 'description': 'Confirmation the volume of submental fat compared the 12 weeks after the last administration to before administration of the IP measured by MRI (Number of Participants: approximately 120)'}, {'measure': 'Satisfaction Evaluation by the subject', 'timeFrame': '4 and 12 weeks', 'description': 'A score of 5 (slightly satisfied) or higher in the subject satisfaction evaluation at 4 and 12 weeks after the last administration to before administration of the IP'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Submental Fat']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the Efficacy and Safety of MT921 in Subjects with Moderate to Severe Submental fat compared with Placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults 19\\~65 years of age\n2. CA-SMFRS and PA-SMFRS score of 2 or 3\n3. Satisfaction level is 3points or less\n4. Voluntarily provide informed consent\n\nExclusion Criteria:\n\n1. Following history that can affect the efficacy and safety evaluation in the chin or neck area as judged by the investigator\n\n * Scars or skin lesion on the study treatment region\n * Liposuction or lipolytic material treatment to decrease submental fat\n * Permanent filler, synthetic implantation and autologous fat grafting\n * Within 1 year of screening visit, semi-permanent filler (Calcium Hydroxyapatite, collagen-stimulator, etc.), radio-frequency treatment, HIFU, thread, laser procedure and chemical peeling procedure over medium-depth\n * Within 6 months of screening visit, temporary filler (Hyaluronic acid, etc.) procedure on the chin or neck, injection of botulinum toxin, radio-frequency treatment, HIFU, thread, laser procedure and chemical peeling procedure over medium-depth\n2. BMI over 35.0 kg/m\\^2\n3. Submandibular enlargement due to causes other than localized subcutaneous fat (hyperthyroidism, cervical lymphadenopathy, etc.)\n4. Current or past dysphagia\n5. Judged difficult to measure submandibular fat due to sagging skin on the chin and neck or wide platysmal bands on the neck\n6. Bleeding or taking anticoagulant drugs (except for patients taking anticoagulant drugs, those who can discontinue administration from 3 days before injection to 24 hours after injection of the IP)\n7. Skin disease or would infection on the study treatment region\n8. Hypersensitivity to Lidocaine, Benzocaine, Procaine or the IP\n9. Pregnancy or breast feeding or female of child-bearing potential who has not agreed to use of medically acceptable contraception during the study period\n\n * All women of childbearing age have negative pregnancy test results can be enrolled in parallel with surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or menopause (amenorrhea for more than 12 months).\n * Medically acceptable contraception: Intrauterine device, Intrauterine system, vasectomy, tubal ligation, condom, Cervical cap, Contraceptive diaphragm, contraceptive sponges, spermicide, oral contraceptive pill and etc.\n10. Experience of other clinical trials within 30 days before screening\n11. Any other clinically meaningful conditions that are considered ineligible for the study in the medical judgement of principal investigator or sub-investigator'}, 'identificationModule': {'nctId': 'NCT05195112', 'briefTitle': 'Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medy-Tox'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat', 'orgStudyIdInfo': {'id': 'MT11-KR19SMF309'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MT921', 'description': '* Injection volume/interval: 0.2mL/1.0cm\n* Number of Injection: Maximum 50 times\n* Concentration per unit area: 3mg/cm2', 'interventionNames': ['Drug: MT921']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '* Injection volume/interval: 0.2mL/1.0cm\n* Number of Injection: Maximum 50 times\n* Concentration per unit area: 0mg/cm2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'MT921', 'type': 'DRUG', 'description': 'Active ingredient', 'armGroupLabels': ['MT921']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Normal Saline', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22332', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medy-Tox', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}