Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2025-12-25 @ 1:01 PM
Study NCT ID:
NCT07072195
Status:
RECRUITING
Last Update Posted:
2025-07-29
First Post:
2025-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of AMC6156 in People With Sarcopenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2025-07-09', 'studyFirstSubmitQcDate': '2025-07-09', 'lastUpdatePostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Short Physical Performance Battery (SPPB) Score from Baseline to Week 12', 'timeFrame': 'At Visit 1 (Screening), Visit 2 (Week 0, Baseline), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12)'}], 'secondaryOutcomes': [{'measure': 'Change in Short Physical Performance Battery (SPPB) Score at Week 4 and Week 8', 'timeFrame': 'At Visit 1 (Screening), Visit 2 (Week 0, Baseline), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12)'}, {'measure': 'Change in Timed Up and Go (TUG) Test Time', 'timeFrame': 'At Visit 2 (Week 0), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12)'}, {'measure': 'Change in Appendicular Skeletal Muscle Mass (ASM) Measured by DXA', 'timeFrame': 'At Visit 1 (Screening) and Visit 5 (Week 12)'}, {'measure': 'Change in Handgrip Strength', 'timeFrame': 'At Visit 1 (Screening), Visit 2 (Week 0) ,Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12)'}, {'measure': 'Change in SARC-F Score', 'timeFrame': 'At Visit 2 (Week 0) and Visit 5 (Week 12)'}, {'measure': 'Change in Sarcopenia Quality of Life (SarQoL) Score', 'timeFrame': 'At Visit 2 (Week 0) and Visit 5 (Week 12)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sarcopenia'], 'conditions': ['Sarcopenia in Elderly', 'Sarcopenia']}, 'descriptionModule': {'briefSummary': 'This clinical trial aims to find out whether AMC6156 can improve physical function and is safe in older adults with sarcopenia. Participants will take AMC6156 or a placebo daily for 12 weeks, and their movement, strength, and safety will be regularly monitored through tests and checkups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Voluntary participation with written informed consent\n* Male ≥ 65 years or postmenopausal female\n* Diagnosed with sarcopenia:\n* ASM \\< 7.0 kg/m² (men) or \\< 5.4 kg/m² (women)\n* Plus low handgrip strength or SPPB ≤ 9\n* MNA screening score ≥ 8\n* Body weight ≥ 35 kg, BMI between 15-30 kg/m²\n* Willing and able to follow exercise and nutrition guidance\n\nExclusion Criteria:\n\n* Allergy to investigational drug\n* History of GI bleeding, ulcers, or severe liver/kidney/heart disease\n* QTc ≥ 450 ms with symptoms\n* Severe COPD, uncontrolled diabetes or thyroid disease\n* Diseases causing cachexia or muscle wasting (e.g., ALS, Parkinson's)\n* Vitamin D deficiency (\\<10 ng/mL), hemoglobin \\<10 g/dL\n* Severe psychiatric disorders or MMSE \\< 21\n* Inability to walk or recent fracture/surgery affecting mobility\n* Use of prohibited medications or recent participation in other clinical trials\n* Investigator deems the subject unsuitable for the study"}, 'identificationModule': {'nctId': 'NCT07072195', 'briefTitle': 'A Study of AMC6156 in People With Sarcopenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Animuscure Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of AMC6156 in Patients With Sarcopenia', 'orgStudyIdInfo': {'id': 'AMC6156_SP_P2A01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AMC6156 0.1mg Treatment Group', 'interventionNames': ['Drug: AMC6156 0.1mg']}, {'type': 'EXPERIMENTAL', 'label': 'AMC6156 0.3mg Treatment Group', 'interventionNames': ['Drug: AMC6156 0.3mg']}, {'type': 'EXPERIMENTAL', 'label': 'AMC6156 1.0mg Treatment Group', 'interventionNames': ['Drug: AMC6156 1.0mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Control Group', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AMC6156 0.1mg', 'type': 'DRUG', 'description': 'Oral administration of AMC6156 in tablet form at a dose of 0.1 mg once daily for 12 weeks.', 'armGroupLabels': ['AMC6156 0.1mg Treatment Group']}, {'name': 'AMC6156 0.3mg', 'type': 'DRUG', 'description': 'Oral administration of AMC6156 in tablet form at a dose of 0.3 mg once daily for 12 weeks.', 'armGroupLabels': ['AMC6156 0.3mg Treatment Group']}, {'name': 'AMC6156 1.0mg', 'type': 'DRUG', 'description': 'Oral administration of AMC6156 in tablet form at a dose of 1.0 mg once daily for 12 weeks.', 'armGroupLabels': ['AMC6156 1.0mg Treatment Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral administration of placebo tablets matching AMC6156 in appearance, once daily for 12 weeks.', 'armGroupLabels': ['Placebo Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13496', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kyounghoon Min, M.D.', 'role': 'CONTACT', 'email': 'minkhrm@gmail.com', 'phone': '+82-10-8973-3732'}, {'name': 'Kyounghoon Min, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHA Bundang Medical Center', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jaeyoung Lim, M.D.', 'role': 'CONTACT', 'email': 'drlim1@snu.ac.kr', 'phone': '+82-10-5390-0373'}, {'name': 'Jaeyoung Lim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '16499', 'city': 'Suwon', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yoonseok Jung, M.D.', 'role': 'CONTACT', 'email': 'yschung@ajou.ac.kr', 'phone': '+82-10-7107-6789'}, {'name': 'Yoonseok Jung, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '03080', 'city': 'Seoul', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sangyoon Lee, M.D.', 'role': 'CONTACT', 'email': 'rehabilee@gmail.com', 'phone': '+82-10-6351-4751'}, {'name': 'Sangyoon Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jooyeon Kim', 'role': 'CONTACT', 'email': 'yeoooonee@animuscure.com', 'phone': '+82-70-4105-6414'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Animuscure Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}