[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567381":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":139,"collaborators":25,"id":141,"slug":25,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":142,"sex":148,"minAge":149,"maxAge":150,"enrollmentInfo":151,"targetDuration":25,"studyType":154,"phases":155,"briefSummary":157,"conditions":158,"keywords":160,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},{"fullName":5,"class":6},"PepGen Inc","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PGN-EDODM1","EXPERIMENTAL","Participants will be randomized to receive ascending doses of PGN-EDODM1, once every 4 weeks (Q4W) for 12 weeks",[13],"Drug: 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Trust","London","UK",{"type":44,"coordinates":122},[123,124],-0.12574,51.50853,{"lat":124,"lon":123},[127],{"name":51,"role":32,"phone":33,"phoneExt":25,"email":34},{"facility":129,"status":38,"city":130,"state":25,"zip":131,"country":109,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Newcastle Upon Tyne Hospitals","Newcastle upon Tyne","NE7 7DN",{"type":44,"coordinates":133},[134,135],-1.61396,54.97328,{"lat":135,"lon":134},[138],{"name":51,"role":32,"phone":33,"phoneExt":25,"email":34},{"type":140,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100567381",false,"NCT06667453","A Clinical Study of PGN-EDODM1 in People With Myotonic Dystrophy Type 1","A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of PGN-EDODM1 in Adult Participants With Myotonic Dystrophy Type 1 (FREEDOM2-DM1)","FREEDOM2-DM1","Inclusion Criteria:\n\n* Confirmed diagnosis of DM1, as defined as having a repeat sequence in the DMPK gene with at least 100 CTG repeats\n* Presence of myotonia\n* Have sufficient muscle mass in bilateral tibialis anterior (TA) muscles that a needle biopsy can safely be performed\n* Body Mass Index (BMI) of \\\u003C 35.0 kg\u002Fm\\^2\n\nExclusion Criteria:\n\n* Congenital DM1\n* Known history or presence of any clinically significant conditions that may interfere with study safety assessments\n* Abnormal laboratory tests at screening considered clinically significant by the Investigator\n* Medications specific for the treatment of myotonia within 2 weeks prior to screening\n* Percent predicted forced vital capacity (FVC) \\\u003C40%\n* Use of an investigational drug, device, or product within 30 days of 5 half-lives of the study drug (whichever is longer) prior to Screening\n\nNote: Other inclusion and exclusion criteria may apply.","ALL","16 Years","65 Years",{"count":152,"type":153},24,"ESTIMATED","INTERVENTIONAL",[156],"PHASE2","The purpose of this study is to learn about the effects of an investigational medicine, PGN-EDODM1, to see how safe and tolerable multiple administrations of PGN-EDODM1 are for people with myotonic dystrophy type 1 (DM1) compared to placebo.",[159],"Myotonic Dystrophy 1",[161,159,162,31,9,163,164],"DM1","Myotonic Dystrophy","Myotonic Muscular Dystrophy","Steinert's Disease","2026-04-23",{"date":167,"type":168},"2026-04-28","ACTUAL",{"date":170,"type":168},"2024-12-10",{"date":172,"type":153},"2027-03",{"name":5,"class":6},8]