Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-02-25 @ 4:37 PM
Study NCT ID:
NCT01910220
Status:
COMPLETED
Last Update Posted:
2014-11-10
First Post:
2013-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess the Safety and Bioeffect of REGN1033 (SAR391786)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-07', 'studyFirstSubmitDate': '2013-07-25', 'studyFirstSubmitQcDate': '2013-07-25', 'lastUpdatePostDateStruct': {'date': '2014-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change in total lean mass', 'timeFrame': 'At week 12', 'description': 'The primary endpoint is percent change in total lean mass at week 12 (day 85)'}], 'secondaryOutcomes': [{'measure': 'Number of TEAEs', 'timeFrame': 'day 1 to day 141', 'description': 'Number of treatment-emergent adverse events (TEAEs) from day 1 (baseline) to day 141 (end of study)'}, {'measure': 'Appendicular lean mass by DXA', 'timeFrame': 'At week 12', 'description': 'Appendicular lean mass by DXA (dual energy X-ray absorptiometry) at week 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This is a study to assess the safety and bioeffect of REGN1033 (SAR391786) in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males and postmenopausal females aged 60 years and older with no significant health issues or clinically significant abnormal laboratory values.\n2. Low activity lifestyle\n3. Diet and exercise adherence\n\nExclusion Criteria:\n\n1. Significant concomitant illness such as, but not limited to cardiac, renal, rheumatologic, gastrointestinal, hematological, skeletal/muscular, neurologic, psychiatric, endocrine, metabolic or immunological disease.\n2. Participation in any clinical trial within 6 months prior to screening.\n3. Hospitalization, immobilization, or major surgical procedure requiring general anesthesia within 6 months prior to screening, or any planned surgical procedures during the study period.\n4. Limb amputation (except for toes) and/or any fracture within 6 months.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed."}, 'identificationModule': {'nctId': 'NCT01910220', 'briefTitle': 'Study to Assess the Safety and Bioeffect of REGN1033 (SAR391786)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'orgStudyIdInfo': {'id': 'R1033-HV-1223'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group 1', 'description': 'placebo', 'interventionNames': ['Other: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'REGN1033 (SAR391786)', 'interventionNames': ['Drug: REGN1033 (SAR391786)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 3', 'description': 'placebo + exercise regimen', 'interventionNames': ['Other: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4', 'description': 'REGN1033 (SAR391786) + exercise regimen', 'interventionNames': ['Drug: REGN1033 (SAR391786)']}], 'interventions': [{'name': 'REGN1033 (SAR391786)', 'type': 'DRUG', 'armGroupLabels': ['Group 2', 'Group 4']}, {'name': 'placebo', 'type': 'OTHER', 'armGroupLabels': ['Group 1', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Athens', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.32924, 'lon': -82.10126}}], 'overallOfficials': [{'name': 'Clinical Trial Management', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regeneron Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}