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proportion of participants with adverse events",null,"Day 1 through end of study",[14,17,19],{"measure":15,"description":11,"timeFrame":16},"Maximum concentration of WVE-007 in plasma (Cmax)","Part A:Day 1 through 169 Part B: Day 1 through 253",{"measure":18,"description":11,"timeFrame":16},"Area under the plasma concentration time curve for WVE-007 from time 0 to last measurable concentration (AUClast)",{"measure":20,"description":11,"timeFrame":21},"Change over time from baseline levels of serum activin E","Part A:Day 1 through 169 Part B: Day 1 through 337",[23,26],{"measure":24,"description":11,"timeFrame":25},"Percent change of weight (kg) from baseline","Day 1 through 169 Part B: Day 1 through 337",{"measure":27,"description":11,"timeFrame":28},"Body composition changes as follows: Change in body fat percentage from baseline, percent change of visceral fat (kg) from baseline, and percent change in fat-free mass (kg) from baseline","Part A: Day 1 through 169 Part B: Day 1 through 337",{"allocation":30,"interventionModel":31,"interventionModelDescription":11,"primaryPurpose":32,"observationalModel":11,"timePerspective":11,"maskingInfo":33},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":34,"maskingDescription":11,"whoMasked":35},"TRIPLE",[36,37,38],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR",[40,46,50,54,58],{"label":41,"type":42,"description":43,"interventionNames":44},"Cohort 1","EXPERIMENTAL","Part A: Experimental WVE-007 (Dose 1) or Placebo Part B Pre-T2D: Experimental WVE-007 (Dose 1) or Placebo",[45],"Drug: WVE-007",{"label":47,"type":42,"description":48,"interventionNames":49},"Cohort 2","Part A: Experimental WVE-007 (Dose 2) or Placebo Part B Pre-T2D: Experimental WVE-007 (Dose 2) or Placebo",[45],{"label":51,"type":42,"description":52,"interventionNames":53},"Cohort 3","Part A: Experimental WVE-007 (Dose 3) or Placebo",[45],{"label":55,"type":42,"description":56,"interventionNames":57},"Cohort 4","Part A: Experimental WVE-007 (Dose 4) or Placebo Part B T2D: Experimental WVE-007 (Dose 4) or Placebo",[45],{"label":59,"type":42,"description":60,"interventionNames":61},"Cohort 5","Part A: Experimental WVE-007 (Dose 5) or Placebo Part B T2D: Experimental WVE-007 (Dose 5) or Placebo",[45],[63],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":11},"DRUG","WVE-007","Stereopure siRNA oligonucleotide",[41,47,51,55,59],[69],{"name":70,"affiliation":71,"role":72},"Medical Director, MD","Wave Life Sciences","STUDY_DIRECTOR",[74],{"name":75,"role":76,"phone":77,"phoneExt":11,"email":78},"Clinical Operations","CONTACT","855-215-4687","Clinicaltrials@wavelifesci.com",[80,99,115,131,145,161],{"facility":81,"status":82,"city":83,"state":84,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"Parexel International-EPCU Baltimore","RECRUITING","Baltimore","Maryland","21225","United 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Macovei","+40711912918","simona.macovei@arensia-em.com",{"facility":132,"status":82,"city":133,"state":11,"zip":134,"country":119,"countryCode":120,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Spitalul Clinic Judetean De Urgenta Cluj","Cluj-Napoca","400006",{"type":89,"coordinates":136},[137,138],23.6,46.76667,{"lat":138,"lon":137},[141],{"name":142,"role":76,"phone":143,"phoneExt":11,"email":144},"Emanuela Beni","+40711912839","emanuela.beni@arensia-em.com",{"facility":146,"status":82,"city":147,"state":11,"zip":148,"country":149,"countryCode":150,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Parexel International Early Phase Clinical Unit","Harrow","HA1 3UJ","United Kingdom","UK",{"type":89,"coordinates":152},[153,154],-0.33208,51.57835,{"lat":154,"lon":153},[157],{"name":158,"role":76,"phone":159,"phoneExt":11,"email":160},"Pablo Forte","01895 614 890","Pablo.ForteSoto@parexel.com",{"facility":162,"status":82,"city":163,"state":11,"zip":164,"country":149,"countryCode":150,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Simbec-Orion Clinical Pharmacology","Merthyr Tydfil","CF48 4DR",{"type":89,"coordinates":166},[167,168],-3.37779,51.74794,{"lat":168,"lon":167},[171],{"name":172,"role":76,"phone":173,"phoneExt":11,"email":174},"Annelize Koch","01685 700870","Annelize.koch@simbecorion.com",{"type":176,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100580813","phase-1-a-phase-12a-study-of-wve-007-in-adults-living-with-overweight-or-obesity-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":190,"type":191},296,"ESTIMATED","INTERVENTIONAL",[194,195],"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.",[198],"Overweight and Obesity","2026-05-29",{"date":201,"type":202},"2026-06-02","ACTUAL",{"date":204,"type":202},"2025-01-31",{"date":206,"type":191},"2027-12",{"name":5,"class":6},6]