[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611837":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":42,"centralContacts":34,"locations":47,"responsibleParty":67,"collaborators":69,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":34,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":34,"studyType":86,"phases":87,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":50,"whyStopped":34,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Ikaria Bioscience Pty Ltd","INDUSTRY",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"RN3161","EXPERIMENTAL","Investigational Product",[13],"Drug: RN3161",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Control","PLACEBO_COMPARATOR","placebo control",[19],"Drug: Placebo Control",{"label":21,"type":10,"description":22,"interventionNames":23},"RN3161 and tirzepatide","In Part 3, RN3161 co-administered with tirezepatide",[13,24],"Drug: Tirzepatide",{"label":26,"type":27,"description":28,"interventionNames":29},"Placebo and tirzepatide","ACTIVE_COMPARATOR","In Part 3; Placebo co-administered with tirzepatide",[19,24],[31,35,38],{"type":32,"name":9,"description":11,"armGroupLabels":33,"otherNames":34},"DRUG",[9,21],null,{"type":32,"name":15,"description":36,"armGroupLabels":37,"otherNames":34},"0.9% normal saline SC injection",[15,26],{"type":32,"name":39,"description":40,"armGroupLabels":41,"otherNames":34},"Tirzepatide","In Part 3; randomized to either RN3161 + tirzepatide or placebo + tirzepatide",[26,21],[43],{"name":44,"affiliation":45,"role":46},"Philip Ryan, MD","Nucleus Network Pty Ltd.","PRINCIPAL_INVESTIGATOR",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Nucleus Network Pty Ltd","RECRUITING","Melbourne","Victoria","3004","Australia","AU",{"type":57,"coordinates":58},"Point",[59,60],144.96332,-37.814,{"lat":60,"lon":59},[63],{"name":44,"role":64,"phone":65,"phoneExt":34,"email":66},"CONTACT","03 85939801","p.ryan@nucleusnetwork.com.au",{"type":68,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[70],{"name":71,"class":6},"Shanghai Rona Therapeutics Co., Ltd.","100611837","phase-1-phase-12a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-pharmacodynamics-and-effect-on-body-weight-of-rn3161-as-monotherapy-and-in-combination-with-tirzepatide-in-adults-with-overweight-and-obesity-100611837",false,"NCT07245771","Phase 1\u002F2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effect on Body Weight of RN3161 as Monotherapy and in Combination With Tirzepatide in Adults With Overweight and Obesity","A Randomized, Double-Blind, Placebo-Controlled Phase 1\u002F2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effect on Body Weight of RN3161 as Monotherapy and in Combination With Tirzepatide in Adults With Overweight and Obesity","Inclusion Criteria:\n\n* BMI:\n\nObesity: BMI ≥ 30 kg\u002Fm² for participants with no Asian ancestry and ≥ 27.5 kg\u002Fm² for participants with Asian ancestry that has been stable (± 5%) for the previous 3 months (based on participant self-report or available medical records), with or without a weight-related comorbidity (excluding diabetes)\n\nOverweight: BMI 27 to \\\u003C30 kg\u002Fm² for participants with no Asian ancestry and 23.0 to \\\u003C27.5 kg\u002Fm² for participants with Asian ancestry that has been stable (± 5%) for the previous 3 months (based on participant self-report or available medical records), with at least 1 weight-related comorbidity (excluding diabetes)\n\nWeight-related comorbidities include a diagnosis of the following:\n\n* Hypertension: seated BP ≤ 140\u002F90 mm Hg; receiving ≤ 2 stable (≥ 4 weeks) agents limited to ACE inhibitors, angiotensin receptor blockers, calcium channel blockers, or thiazide ≤ 25 mg, or untreated\n* Dyslipidemia: stable use of lipid-lowering agents for dyslipidemia (LDL-C \\\u003C 150 mg\u002FdL, triglycerides \\\u003C 300 mg\u002FdL)\n* Osteoarthritis\n\nExclusion Criteria:\n\n* self-reported or documented weight gain or loss \\>5% within 3 months prior to screening\n* use of GLP1R agonists within 6 months of screening\n* intolerance to GLP-1 medications in the past\n* use of non-GLP1R medications for weight loss within 3 months of screening\n* HbA1c \\>6.5%\n* diagnosis of significant liver disease\n* history of malignancy or anaphylaxis\n* use of any siRNA agent in the prior 12 months",true,"ALL","18 Years","65 Years",{"count":84,"type":85},104,"ESTIMATED","INTERVENTIONAL",[88,89],"PHASE1","PHASE2","Study to assess the safety, pharmacokinetics (the amount of study drug or any of its breakdown products in your body) and pharmacodynamics (how the study drug affects your body) of RN3161 alone (healthy volunteers) and RN3161 with tirzepatide (overweight and obese subjects)",[92],"Obesity &Amp; 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