[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Wave Life Sciences USA, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":28,"conditions":29,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"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":22,"type":23},296,"ESTIMATED","INTERVENTIONAL",[26,27],"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.",[30],"Overweight and Obesity","RECRUITING","2026-05-29",{"date":34,"type":35},"2026-06-02","ACTUAL",{"date":37,"type":35},"2025-01-31",{"date":39,"type":23},"2027-12",{"name":41,"class":42},"Wave Life Sciences USA, Inc.","INDUSTRY",6,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":51,"minAge":52,"maxAge":19,"enrollmentInfo":53,"targetDuration":4,"studyType":24,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100432080","phase-1-open-label-study-of-wve-n531-in-patients-with-duchenne-muscular-dystrophy-forward-53-100432080","NCT04906460","Open-label Study of WVE-N531 in Patients With Duchenne Muscular Dystrophy (FORWARD-53)","An Open-label Phase 1b\u002F2 Study of WVE-N531 in Patients With Duchenne Muscular Dystrophy","Inclusion Criteria:\n\nPart A and Part B:\n\n1. Part A patients may be screened for Part B upon completion of a washout period of ≥18 weeks from last dose in Part A. New patients may also be screened for Part B\n2. Diagnosis of DMD based on clinical phenotype.\n3. Documented mutation in the DMD gene associated with DMD that is amenable to exon 53 intervention\n4. Score of ≥1 on item 1 or 2 of the shoulder component of the Performance of the Upper Limb (PUL) (Part B ).\n5. Ambulatory or non-ambulatory male\n6. Stable pulmonary and cardiac function, as measured by the following: (Part B):\n\n1\\. Reproducible percent predicted forced vital capacity (FVC) ≥50%; 2. Left ventricular ejection fraction (LVEF) \\>55% in patients \\\u003C10 years of age and \\>45% in patients ≥10 years of age, as measured (and documented) by echocardiogram (ECHO) and\u002For cardiac magnetic resonance imaging (MRI), within 6 months prior to enrollment into the study.\n\n7.Adequate muscle at Screening to perform open muscle biopsies, preferably deltoid.\n\n8\\. Currently on a stable corticosteroid therapy regimen, defined as initiation of systemic corticosteroid therapy that occurred ≥6 months prior to Screening and no changes in dose ≤3 months prior to Screening visit (Part B ).\n\nPart C\n\n1. New patients to be screened for Part C.\n2. Diagnosis of DMD based on clinical phenotype.\n3. Documented mutation in the DMD gene associated with DMD that is amenable to exon 53 intervention\n4. Score of ≥1 on item 1 or 2 of the shoulder component of the Performance of the Upper Limb (PUL) .\n5. Ambulatory male\n6. Stable pulmonary and cardiac function, as measured by the following:\n\n1\\. Reproducible percent predicted forced vital capacity (FVC) ≥50%; 2. Left ventricular ejection fraction (LVEF) \\>55% in patients as measured (and documented) by echocardiogram (ECHO) and\u002For cardiac magnetic resonance imaging (MRI), within 6 months prior to enrollment into the study.\n\n7\\. Adequate muscle at Screening to perform open muscle biopsies, preferably deltoid.\n\n8\\. Currently on a stable corticosteroid therapy regimen, defined as initiation of systemic corticosteroid therapy that occurred ≥6 months prior to Screening and no changes in dose ≤3 months prior to Screening visit .\n\nExclusion Criteria:\n\n1. Clinically significant medical finding on the physical examination other than DMD that, in the judgment of the Investigator, will make the patient unsuitable for participation in, and\u002For completion of the study procedures.\n2. Part B and Part C: Major surgery within 3 months prior to Day 1 or planned major surgery for any time during the study.\n3. Part B: Diagnosis of active alcohol, cannabinoid, or other substance use disorder (except nicotine) within 6 months prior to the Screening visit\n4. Part C: Any recreational substance use (including prescribed cannabinoids), with the exception of nicotine, irrespective of legality, within 2 months prior to Screening and\u002For unwilling to refrain from such use for the duration of the study.","MALE","4 Years",{"count":54,"type":23},26,[26,27],"This is a Phase 1b\u002F2 open-label study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical effects of intravenous (IV) WVE-N531 in patients with Duchenne muscular dystrophy (DMD). To participate in the study, patients must have a documented mutation of the DMD gene that is amenable to exon 53 skipping intervention. This study has 3 parts, Part A, Part B, including Part B Extension Arm, and Part C. Part A is completed. Part B is completed. Following completion of Part B, all patients elected to continue to receive study drug in the optional Part B open-label Extension Arm. Part C has been added to the study and will enroll new patients.",[58],"Duchenne Muscular Dystrophy","2025-12-08",{"date":61,"type":35},"2025-12-15",{"date":63,"type":35},"2021-09-28",{"date":65,"type":23},"2027-04-24",{"name":41,"class":42},5,""]