[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ikaria Bioscience Pty Ltd\",\"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,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100619673","phase-1-phase-1a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-rn5681-in-healthy-volunteers-100619673",false,"NCT07347678","Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RN5681 in Healthy Volunteers","A Phase 1a, Randomized, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RN5681 in Healthy Volunteers","Inclusion Criteria:\n\n* Body mass index (BMI) 18 to 35 kg\u002Fm2\n* Fasting LDL-C ≥70 mg\u002FdL (1.81 mmol\u002FL) (all SAD cohorts); fasting LDL-C ≥100 mg\u002FdL (2.59 mmol\u002FL) (POC cohort only)\n* Lp(a) at Screening: SAD cohort: ≥25 nmol\u002FL POC cohort: ≥100 nmol\u002FL\n* Fasting triglycerides \\\u003C400 mg\u002FdL (4.51 mmol\u002FL) at Screening\n* No clinically significant abnormalities of hepatic or renal function\n\nExclusion Criteria:\n\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>1.5× the upper limit of normal at screening\n* Hemoglobin A1c (HbA1c) ≥6.5% at screening\n* Current regular smoker (defined as \\>2 cigarettes\u002Fday or \\>10 cigarettes\u002Fweek) within 3 months prior to screening\n* Use of any siRNA, antisense oligonucleotide (ASO), cell and gene therapy, or clustered regularly interspaced short palindromic repeats (CRISPR) agent in the prior 12 months\n* Received any prescription lipid-lowering medication, including but not limited to statins, ezetimibe, and PCSK9 inhibitors to alter serum lipids within 30 days before screening",true,"ALL","18 Years","65 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single doses of RN5681 in Adult healthy subjects",[28],"High Cholesterol","RECRUITING","2026-03-30",{"date":32,"type":33},"2026-04-03","ACTUAL",{"date":35,"type":33},"2026-03-12",{"date":37,"type":22},"2027-07",{"name":39,"class":40},"Ikaria Bioscience Pty Ltd","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":48,"targetDuration":4,"studyType":23,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"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","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",{"count":49,"type":22},104,[25,51],"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)",[54],"Obesity &Amp; Overweight",[56,57,58],"obesity","overweight","healthy volunteers","2025-11-17",{"date":61,"type":33},"2025-11-24",{"date":63,"type":33},"2025-11-04",{"date":65,"type":22},"2027-08-15",{"name":39,"class":40},1,""]