[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630381":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":243,"collaborators":30,"id":245,"slug":30,"hasResults":246,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":30,"eligibilityCriteria":250,"healthyVolunteers":246,"sex":251,"minAge":252,"maxAge":30,"enrollmentInfo":253,"targetDuration":30,"studyType":256,"phases":257,"briefSummary":259,"conditions":260,"keywords":266,"overallStatus":43,"whyStopped":30,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":286},{"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 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Terrell","317-278-6266","jkramey@iu.edu",{"facility":73,"status":43,"city":74,"state":75,"zip":76,"country":47,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Roy Blunt NextGen Precision Health Institute","Columbia","Missouri","65211",{"type":49,"coordinates":78},[79,80],-92.33407,38.95171,{"lat":80,"lon":79},[83],{"name":84,"role":37,"phone":85,"phoneExt":30,"email":86},"Heather McHatton","573-882-7619","heathermchatton@health.missouri.edu",{"facility":42,"status":43,"city":88,"state":89,"zip":90,"country":47,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Hillsborough","North Carolina","27278",{"type":49,"coordinates":92},[93,94],-79.09973,36.07542,{"lat":94,"lon":93},[97],{"name":98,"role":37,"phone":99,"phoneExt":30,"email":100},"Hannah Nation","984-314-2252","hannah.nation@rarediseaseresearch.com",{"facility":102,"status":43,"city":103,"state":104,"zip":105,"country":47,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"The University of Texas Health Science Center at San Antonio","San Antonio","Texas","78229",{"type":49,"coordinates":107},[108,109],-98.49363,29.42412,{"lat":109,"lon":108},[112],{"name":113,"role":37,"phone":114,"phoneExt":30,"email":115},"Marlon Humbert Tamayo Muradas","210-450-7370","tamayomurada@uthscsa.edu",{"facility":117,"status":43,"city":118,"state":30,"zip":119,"country":120,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"UZ Leuven","Leuven","3000","Belgium",{"type":49,"coordinates":122},[123,124],4.70093,50.87959,{"lat":124,"lon":123},[127],{"name":128,"role":37,"phone":129,"phoneExt":30,"email":130},"Britt Van Lancker","32 16 34 88 59","britt.vanlancker@uzleuven.be",{"facility":132,"status":43,"city":133,"state":30,"zip":134,"country":135,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Rigshospitalet, (Neuromuscular Clinic and Research Unit, Department 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Innenstadt","Munich","Bavaria","80336","Germany",{"type":49,"coordinates":168},[169,170],11.57549,48.13743,{"lat":170,"lon":169},[173],{"name":174,"role":37,"phone":175,"phoneExt":30,"email":176},"Riccardo Morbio","+ 49 89 4400 72523","Riccardo.Morbio@med.uni-muenchen.de",{"facility":178,"status":43,"city":179,"state":180,"zip":181,"country":166,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"Charité Universitätsmedizin Berlin Campus-Buch Muscle Research Unit","Berlin","State of Berlin","13125",{"type":49,"coordinates":183},[184,185],13.41053,52.52437,{"lat":185,"lon":184},[188],{"name":189,"role":37,"phone":190,"phoneExt":30,"email":191},"Elisabetta Gazzerro, Dr med","0049 172 23 53 192","Elisabetta.gazzerro@charite.de",{"facility":193,"status":43,"city":194,"state":195,"zip":196,"country":197,"cosmosGeoPoint":30,"geoPoint":30,"contacts":198},"National Hospital Organization Osaka Toneyama Medical Center","Toyonaka-Shi","Osaka","560-8552","Japan",[199],{"name":200,"role":37,"phone":201,"phoneExt":30,"email":202},"Tsuyoshi Matsumura, MD, PhD","81668532001","matsumura.tsuyoshi.kq@mail.hosp.go.jp",{"facility":204,"status":43,"city":205,"state":206,"zip":207,"country":197,"cosmosGeoPoint":30,"geoPoint":30,"contacts":208},"Yamaguchi University Hospital","Ube-Shi","Yamaguchi","755-8505",[209],{"name":210,"role":37,"phone":30,"phoneExt":30,"email":211},"Masayuki Nakamori, MD, PhD, Professor","mnakamor@yamaguchi-u.ac.jp",{"facility":213,"status":43,"city":214,"state":215,"zip":216,"country":217,"cosmosGeoPoint":218,"geoPoint":222,"contacts":223},"Hospital Universitario Infanta Sofía","San Sebastián de los Reyes","Madrid","28702","Spain",{"type":49,"coordinates":219},[220,221],-3.62733,40.55555,{"lat":221,"lon":220},[224],{"name":225,"role":37,"phone":226,"phoneExt":30,"email":227},"Gerardo Gutierrez Gutierrez","+34 91 191 40 00","g3.neuro@gmail.com",{"facility":229,"status":43,"city":230,"state":231,"zip":232,"country":233,"cosmosGeoPoint":234,"geoPoint":238,"contacts":239},"University College London Hospitals NHS Foundation Trust National Hospital for Neurology and Neurosurgery","London","England","WC1N 3BG","United Kingdom",{"type":49,"coordinates":235},[236,237],-0.12574,51.50853,{"lat":237,"lon":236},[240],{"name":241,"role":37,"phone":30,"phoneExt":30,"email":242},"Vino Vivekanandam, PhD","v.vivekanandam@ucl.ac.uk",{"type":244,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","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":254,"type":255},150,"ESTIMATED","INTERVENTIONAL",[258],"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).",[261,262,263,264,265],"Myotonic Dystrophy Type 1 (DM1)","DM1","Myotonic Dystrophy","Steinert Disease","Steinert",[262,263,267,268,261,269,270,264,265,271,272,5,273,274,275,276],"Myotonic Dystrophy 1","Myotonia","Dystrophy Myotonic","Myotonic Disorders","Myotonic Muscular Dystrophy","HARMONIA","Dyne","DYNE-101","zeleciment basivarsen","z-basivarsen","2026-06-26",{"date":279,"type":280},"2026-06-30","ACTUAL",{"date":282,"type":280},"2026-05-14",{"date":284,"type":255},"2029-01",{"name":5,"class":6},14]