[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"PepGen Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":81},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100567381","phase-2-a-clinical-study-of-pgn-edodm1-in-people-with-myotonic-dystrophy-type-1-100567381",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":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28],"Myotonic Dystrophy 1",[30,28,31,32,33,34,35],"DM1","Myotonic Dystrophy","PepGen","PGN-EDODM1","Myotonic Muscular Dystrophy","Steinert's Disease","RECRUITING","2026-04-23",{"date":39,"type":40},"2026-04-28","ACTUAL",{"date":42,"type":40},"2024-12-10",{"date":44,"type":22},"2027-03",{"name":46,"class":47},"PepGen Inc","INDUSTRY",8,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},"100609901","phase-2-an-open-label-extension-study-of-pgn-edodm1-in-people-with-myotonic-dystrophy-type-1-freedom-ole-100609901","NCT07220603","An Open-Label Extension Study of PGN-EDODM1 in People With Myotonic Dystrophy Type 1 (FREEDOM-OLE)","An Open-Label Extension Study Evaluating Safety and Pharmacokinetics in Participants With Myotonic Dystrophy Type 1 (FREEDOM-OLE)","Inclusion Criteria:\n\n* Participant has completed a prior study with PGN-EDODM1\n\nExclusion Criteria:\n\n* Abnormal laboratory tests at screening considered clinically significant by the Investigator\n* Use of an investigational drug (other than PGN-EDODM1), device, or product, within 30 days or 5 half-lives of the study drug (whichever is longer) prior to study entry",{"count":57,"type":22},48,[25],"The purpose of this study is to learn about the long-term safety and tolerability of PGN-EDODM1 in participants with myotonic dystrophy type 1 (DM1) who have completed a prior study with PGN-EDODM1.",[28],[30,28,31,32,33,34,62,63,64,65,66,67,68,69,70,71],"Steinhert's Disease","Myotonic Dystrophies","Genetic Diseases, Inborn","Neuromuscular Diseases","Nervous System Diseases","Musculoskeletal Diseases","Myotonic Disorders","Muscular Disorders, Atrophic","Heredodegenerative Disorders, Nervous System","Muscular Diseases","2026-03-26",{"date":74,"type":40},"2026-03-30",{"date":76,"type":40},"2025-12-23",{"date":78,"type":22},"2029-01",{"name":46,"class":47},3,""]