[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580813":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":37,"centralContacts":42,"locations":48,"responsibleParty":140,"collaborators":36,"id":142,"slug":36,"hasResults":143,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":149,"sex":150,"minAge":151,"maxAge":152,"enrollmentInfo":153,"targetDuration":36,"studyType":156,"phases":157,"briefSummary":160,"conditions":161,"keywords":36,"overallStatus":51,"whyStopped":36,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"Wave Life Sciences USA, Inc.","INDUSTRY",[8,14,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","Part A: Experimental WVE-007 (Dose 1) or Placebo Part B Pre-T2D: Experimental WVE-007 (Dose 1) or Placebo",[13],"Drug: WVE-007",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2","Part A: Experimental WVE-007 (Dose 2) or Placebo Part B Pre-T2D: Experimental WVE-007 (Dose 2) or Placebo",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort 3","Part A: Experimental WVE-007 (Dose 3) or Placebo",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Cohort 4","Part A: Experimental WVE-007 (Dose 4) or Placebo Part B T2D: Experimental WVE-007 (Dose 4) or Placebo",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Cohort 5","Part A: Experimental WVE-007 (Dose 5) or Placebo Part B T2D: Experimental WVE-007 (Dose 5) or Placebo",[13],[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","WVE-007","Stereopure siRNA oligonucleotide",[9,15,19,23,27],null,[38],{"name":39,"affiliation":40,"role":41},"Medical Director, MD","Wave Life Sciences","STUDY_DIRECTOR",[43],{"name":44,"role":45,"phone":46,"phoneExt":36,"email":47},"Clinical Operations","CONTACT","855-215-4687","Clinicaltrials@wavelifesci.com",[49,67,82,97,111,126],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Parexel International-EPCU Baltimore","RECRUITING","Baltimore","Maryland","21225","United States",{"type":57,"coordinates":58},"Point",[59,60],-76.61219,39.29038,{"lat":60,"lon":59},[63],{"name":64,"role":45,"phone":65,"phoneExt":36,"email":66},"Ronald Goldwater, M.D.","877-617-8839","study.baltimore@parexel.com",{"facility":68,"status":51,"city":69,"state":36,"zip":70,"country":71,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"ARENSIA Research Clinic","Chisinau","MD-2025","Moldova",{"type":57,"coordinates":73},[74,75],28.85938,47.00902,{"lat":75,"lon":74},[78],{"name":79,"role":45,"phone":80,"phoneExt":36,"email":81},"Maxim Bogus","373 78883374","Maxim.bogus@arensia-em.com",{"facility":83,"status":51,"city":84,"state":36,"zip":85,"country":86,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Arensia Clinics S.R.L.","Bucharest","011658","Romania",{"type":57,"coordinates":88},[89,90],26.10626,44.43225,{"lat":90,"lon":89},[93],{"name":94,"role":45,"phone":95,"phoneExt":36,"email":96},"Simona Macovei","+40711912918","simona.macovei@arensia-em.com",{"facility":98,"status":51,"city":99,"state":36,"zip":100,"country":86,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Spitalul Clinic Judetean De Urgenta Cluj","Cluj-Napoca","400006",{"type":57,"coordinates":102},[103,104],23.6,46.76667,{"lat":104,"lon":103},[107],{"name":108,"role":45,"phone":109,"phoneExt":36,"email":110},"Emanuela Beni","+40711912839","emanuela.beni@arensia-em.com",{"facility":112,"status":51,"city":113,"state":36,"zip":114,"country":115,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Parexel International Early Phase Clinical Unit","Harrow","HA1 3UJ","United Kingdom",{"type":57,"coordinates":117},[118,119],-0.33208,51.57835,{"lat":119,"lon":118},[122],{"name":123,"role":45,"phone":124,"phoneExt":36,"email":125},"Pablo Forte","01895 614 890","Pablo.ForteSoto@parexel.com",{"facility":127,"status":51,"city":128,"state":36,"zip":129,"country":115,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Simbec-Orion Clinical Pharmacology","Merthyr Tydfil","CF48 4DR",{"type":57,"coordinates":131},[132,133],-3.37779,51.74794,{"lat":133,"lon":132},[136],{"name":137,"role":45,"phone":138,"phoneExt":36,"email":139},"Annelize Koch","01685 700870","Annelize.koch@simbecorion.com",{"type":141,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100580813",false,"NCT06842186","A Phase 1\u002F2a Study of WVE-007 in Adults Living With Overweight or Obesity","A Phase 1\u002F2a, Randomized, Double-blind, Placebo-controlled Study of Ascending Doses of WVE-007 to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Adults Living With Overweight or Obesity","INLIGHT","Inclusion Criteria: Part A\n\n* Male and female participants aged 18 to 60 years\n* BMI 28 to 35 kg\u002Fm2 which has been stable (±5%) for the previous 3 to 6 months (based on participant self-report or medical records). For participants considered for enrollment in a cohort expansion, BMI 28 to 40 kg\u002F m2 will be allowed.\n* Healthy, in the opinion of the Investigator, as determined by prestudy medical history, physical examination, and clinical laboratory assessments\n\nInclusion Criteria : Part B\n\n* Male and female participants aged 18 to 60 years\n* BMI 35 to 50 kg\u002Fm2 (inclusive)\n* Thyroid stimulating hormone is within normal range at Screening. May be on supplemental thyroid hormone as managed by their prescribing physician and stable within the last 60 days\n* Have Pre T2D or T2D\n\nExclusion Criteria: Part A\n\n* History or presence of CV disease, including heart failure (New York Heart Association \\[NYHA\\] Class III or IV), myocardial infarction, angina, or clinically significant abnormal laboratory assessments\n* History or presence of thyroid disorders\n* Medical history or diagnosis of causes of liver disease\n* Use of any siRNA agent in the prior 12 months\n* Received an investigational agent within 90 days or 5 half-lives, whichever is longer, before the first dose of study drug or are in follow-up of another clinical study\n\nExclusion Criteria: Part B\n\n* History of significant CV disease in the opinion of the Investigator.\n* Use of prescription medications (ie, anti-obesity or psychiatric medications) within 14 days or 7 half-lives (whichever is longer) before the first dose of study drug, except for allowed antihypertensive medications and statins.\n* Taking \\>2 antihypertensive medications, or antihypertensive medication dose was changed in the 60 days prior to Screening.\n* Taking \\>1 cholesterol-lowering medication, or cholesterol-lowering medication dose was changed in the 60 days prior to Screening.\n* Cohorts 1 and 2 (preT2D) only: use of any GLP-1 receptor agonists or dual incretin agonists within the 4 months prior to Screening.\n* Cohorts 4 and 5 (T2D) only: use of insulin or any medication that directly stimulates pancreatic insulin within the 60 days prior to Screening, including sulfonylureas, meglitinides, GLP-1 receptor agonists, dual incretin agonists, and DPP-4 inhibitors.\n* Use of any siRNA agent in the prior 12 months.\n* Received an investigational agent within 90 days or 5 half-lives, whichever is longer, before the first dose of study drug or are in follow-up of another clinical study.",true,"ALL","18 Years","60 Years",{"count":154,"type":155},296,"ESTIMATED","INTERVENTIONAL",[158,159],"PHASE1","PHASE2","The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending doses of WVE-007 when administered subcutaneously (SC) . Part A is a single ascending dose study in adults living with overweight and obesity. The Part B of the study is a repeat dose administration in two adult populations: Pre Type 2 diabetes (Pre T2D) and Type 2 Diabetes (T2D) in adults who are affected by obesity.",[162],"Overweight and Obesity","2026-05-29",{"date":165,"type":166},"2026-06-02","ACTUAL",{"date":168,"type":166},"2025-01-31",{"date":170,"type":155},"2027-12",{"name":5,"class":6},6]