[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630381":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":251,"collaborators":30,"id":253,"slug":254,"hasResults":255,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":30,"eligibilityCriteria":259,"healthyVolunteers":255,"sex":260,"minAge":261,"maxAge":30,"enrollmentInfo":262,"targetDuration":30,"studyType":265,"phases":266,"briefSummary":268,"conditions":269,"keywords":275,"overallStatus":43,"whyStopped":30,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":295},{"fullName":5,"class":6},"Dyne Therapeutics","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo-Controlled Period: DYNE-101","EXPERIMENTAL","Participants will be randomized to receive DYNE-101, once every 8 weeks (Q8W) for up to 48 weeks.",[13],"Drug: zeleciment basivarsen (DYNE-101)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo-Controlled Period: Placebo","PLACEBO_COMPARATOR","Participants will be randomized to receive DYNE-101 matching placebo, Q8W for up to 48 weeks.",[19],"Drug: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"Long-Term Extension Period: DYNE-101","Participants who receive DYNE-101 in Placebo-Controlled Period will continue to received DYNE-101, Q8W for up to 24 weeks.\n\nParticipants who received placebo in Placebo-Controlled Period will receive DYNE-101, Q8W for up to 24 weeks.",[13,19],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","zeleciment basivarsen (DYNE-101)","Administered by IV infusion",[21,9],null,{"type":26,"name":32,"description":28,"armGroupLabels":33,"otherNames":30},"Placebo",[21,15],[35],{"name":36,"role":37,"phone":38,"phoneExt":30,"email":39},"Dyne Clinical Trials","CONTACT","+1-781-317-1919","clinicaltrials@dyne-tx.com",[41,58,73,88,102,117,133,149,165,182,197,209,218,235],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Rare Disease Research, LLC","RECRUITING","Atlanta","Georgia","30329","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-84.38798,33.749,{"lat":53,"lon":52},[56],{"name":30,"role":37,"phone":30,"phoneExt":30,"email":57},"subjectrecruiting@rarediseaseresearch.com",{"facility":59,"status":43,"city":60,"state":61,"zip":62,"country":47,"countryCode":48,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"IU Health Neuroscience Center","Indianapolis","Indiana","46202",{"type":50,"coordinates":64},[65,66],-86.15804,39.76838,{"lat":66,"lon":65},[69],{"name":70,"role":37,"phone":71,"phoneExt":30,"email":72},"Jennifer Terrell","317-278-6266","jkramey@iu.edu",{"facility":74,"status":43,"city":75,"state":76,"zip":77,"country":47,"countryCode":48,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Roy Blunt NextGen Precision Health Institute","Columbia","Missouri","65211",{"type":50,"coordinates":79},[80,81],-92.33407,38.95171,{"lat":81,"lon":80},[84],{"name":85,"role":37,"phone":86,"phoneExt":30,"email":87},"Heather McHatton","573-882-7619","heathermchatton@health.missouri.edu",{"facility":42,"status":43,"city":89,"state":90,"zip":91,"country":47,"countryCode":48,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Hillsborough","North Carolina","27278",{"type":50,"coordinates":93},[94,95],-79.09973,36.07542,{"lat":95,"lon":94},[98],{"name":99,"role":37,"phone":100,"phoneExt":30,"email":101},"Hannah Nation","984-314-2252","hannah.nation@rarediseaseresearch.com",{"facility":103,"status":43,"city":104,"state":105,"zip":106,"country":47,"countryCode":48,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"The University of Texas Health Science Center at San Antonio","San Antonio","Texas","78229",{"type":50,"coordinates":108},[109,110],-98.49363,29.42412,{"lat":110,"lon":109},[113],{"name":114,"role":37,"phone":115,"phoneExt":30,"email":116},"Marlon Humbert Tamayo Muradas","210-450-7370","tamayomurada@uthscsa.edu",{"facility":118,"status":43,"city":119,"state":30,"zip":120,"country":121,"countryCode":122,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"UZ Leuven","Leuven","3000","Belgium","BE",{"type":50,"coordinates":124},[125,126],4.70093,50.87959,{"lat":126,"lon":125},[129],{"name":130,"role":37,"phone":131,"phoneExt":30,"email":132},"Britt Van Lancker","32 16 34 88 59","britt.vanlancker@uzleuven.be",{"facility":134,"status":43,"city":135,"state":30,"zip":136,"country":137,"countryCode":138,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Rigshospitalet, (Neuromuscular Clinic and Research Unit, Department 8077)","Copenhagen","2100","Denmark","DK",{"type":50,"coordinates":140},[141,142],12.56553,55.67594,{"lat":142,"lon":141},[145],{"name":146,"role":37,"phone":147,"phoneExt":30,"email":148},"Nicolai Rasmus Preisler","45 35457257","nicolai.rasmus.preisler@regionh.dk",{"facility":150,"status":43,"city":151,"state":30,"zip":152,"country":153,"countryCode":154,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Pitié-Salpêtrière Hospital","Paris","75013","France","FR",{"type":50,"coordinates":156},[157,158],2.3488,48.85341,{"lat":158,"lon":157},[161],{"name":162,"role":37,"phone":163,"phoneExt":30,"email":164},"Nassima Ait Tahar","+ 33 1 42 16 37 63","n.ait-tahar@institut-myologie.org",{"facility":166,"status":43,"city":167,"state":168,"zip":169,"country":170,"countryCode":171,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"LMU Klinikum der Universität München Neurologische Klinik und Poliklinik Friedrich-Baur-Institut Campus Innenstadt","Munich","Bavaria","80336","Germany","DE",{"type":50,"coordinates":173},[174,175],11.57549,48.13743,{"lat":175,"lon":174},[178],{"name":179,"role":37,"phone":180,"phoneExt":30,"email":181},"Riccardo Morbio","+ 49 89 4400 72523","Riccardo.Morbio@med.uni-muenchen.de",{"facility":183,"status":43,"city":184,"state":185,"zip":186,"country":170,"countryCode":171,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"Charité Universitätsmedizin Berlin Campus-Buch Muscle Research Unit","Berlin","State of Berlin","13125",{"type":50,"coordinates":188},[189,190],13.41053,52.52437,{"lat":190,"lon":189},[193],{"name":194,"role":37,"phone":195,"phoneExt":30,"email":196},"Elisabetta Gazzerro, Dr med","0049 172 23 53 192","Elisabetta.gazzerro@charite.de",{"facility":198,"status":43,"city":199,"state":200,"zip":201,"country":202,"countryCode":203,"cosmosGeoPoint":30,"geoPoint":30,"contacts":204},"National Hospital Organization Osaka Toneyama Medical Center","Toyonaka-Shi","Osaka","560-8552","Japan","JP",[205],{"name":206,"role":37,"phone":207,"phoneExt":30,"email":208},"Tsuyoshi Matsumura, MD, PhD","81668532001","matsumura.tsuyoshi.kq@mail.hosp.go.jp",{"facility":210,"status":43,"city":211,"state":212,"zip":213,"country":202,"countryCode":203,"cosmosGeoPoint":30,"geoPoint":30,"contacts":214},"Yamaguchi University Hospital","Ube-Shi","Yamaguchi","755-8505",[215],{"name":216,"role":37,"phone":30,"phoneExt":30,"email":217},"Masayuki Nakamori, MD, PhD, Professor","mnakamor@yamaguchi-u.ac.jp",{"facility":219,"status":43,"city":220,"state":221,"zip":222,"country":223,"countryCode":224,"cosmosGeoPoint":225,"geoPoint":229,"contacts":230},"Hospital Universitario Infanta Sofía","San Sebastián de los Reyes","Madrid","28702","Spain","ES",{"type":50,"coordinates":226},[227,228],-3.62733,40.55555,{"lat":228,"lon":227},[231],{"name":232,"role":37,"phone":233,"phoneExt":30,"email":234},"Gerardo Gutierrez Gutierrez","+34 91 191 40 00","g3.neuro@gmail.com",{"facility":236,"status":43,"city":237,"state":238,"zip":239,"country":240,"countryCode":241,"cosmosGeoPoint":242,"geoPoint":246,"contacts":247},"University College London Hospitals NHS Foundation Trust National Hospital for Neurology and Neurosurgery","London","England","WC1N 3BG","United Kingdom","UK",{"type":50,"coordinates":243},[244,245],-0.12574,51.50853,{"lat":245,"lon":244},[248],{"name":249,"role":37,"phone":30,"phoneExt":30,"email":250},"Vino Vivekanandam, PhD","v.vivekanandam@ucl.ac.uk",{"type":252,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100630381","phase-3-efficacy-safety-and-tolerability-of-zeleciment-basivarsen-dyne-101-in-participants-with-myotonic-dystrophy-type-1-100630381",false,"NCT07486934","Efficacy, Safety, and Tolerability of Zeleciment Basivarsen (DYNE-101) in Participants With Myotonic Dystrophy Type 1","A Phase 3, Randomized, Double-Blind, 48-Week Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of DYNE-101 Administered to Participants With Myotonic Dystrophy Type 1","Inclusion Criteria:\n\n* Diagnosis of DM1 confirmed by molecular genetics with trinucleotide repeat size greater than (\\>) 100. Historical results from clinical testing are acceptable.\n* Able to walk 10 meters and complete 5 times sit to stand independently (inserts or supports that don't go above the ankle are allowed).\n* Body mass index (BMI) less than (\\\u003C) 35 kilograms per meter square (kg\u002Fm\\^2).\n\nExclusion Criteria:\n\n* A known diagnosis of congenital DM1.\n* History of major surgical procedure (based on Investigator judgment) within 12 weeks prior to the start of screening, with the exception of implanted pacemaker or defibrillator.\n* Use of glucagon-like peptide 1 (GLP-1) agonist\u002Fincretin medications including semaglutide, dulaglutide, liraglutide, exenatide, or tirzepatide within a period of 5 half-lives of the medication prior to performing screening assessments.\n\nNote: Other inclusion and exclusion criteria may apply.","ALL","16 Years",{"count":263,"type":264},150,"ESTIMATED","INTERVENTIONAL",[267],"PHASE3","The purpose of the study is to assess the efficacy, safety, and tolerability of zeleciment basivarsen (DYNE-101) for the treatment of myotonic dystrophy 1 (DM1).",[270,271,272,273,274],"Myotonic Dystrophy Type 1 (DM1)","DM1","Myotonic Dystrophy","Steinert Disease","Steinert",[271,272,276,277,270,278,279,273,274,280,281,5,282,283,284,285],"Myotonic Dystrophy 1","Myotonia","Dystrophy Myotonic","Myotonic Disorders","Myotonic Muscular Dystrophy","HARMONIA","Dyne","DYNE-101","zeleciment basivarsen","z-basivarsen","2026-06-26",{"date":288,"type":289},"2026-06-30","ACTUAL",{"date":291,"type":289},"2026-05-14",{"date":293,"type":264},"2029-01",{"name":5,"class":6},14]