[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"35Pharma Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":60},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100603971","phase-1-a-study-of-hs235-for-treatment-of-pulmonary-arterial-hypertension-pah-in-adults-100603971",false,"NCT07143448","A Study of HS235 for Treatment of Pulmonary Arterial Hypertension (PAH) in Adults","Phase 1b\u002F2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study Assessing the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of HS235 Added to Background Treatment in Adults With PAH","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if they meet all of the following criteria:\n\n1. Male and female participants, 18 years of age and older.\n2. Body Mass Index (BMI) 18.5 and 40 kg\u002Fm2 and body weight at or below 120 kg.\n3. Baseline RHC performed during the Screening Period documenting:\n\n   1. A minimum PVR of ≥ 5 Wood units (WU) or ≥ 400 dyn·sec·cm-5 and,\n   2. A pulmonary artery wedge pressure (PAWP) of ≤ 15 mm Hg.\n4. Diagnosis of WHO pulmonary arterial hypertension (PAH) Group 1.\n5. Symptomatic PAH classified as WHO Functional class II to IV.\n6. On stable doses of at least 2 approved background PAH therapies and diuretics.\n7. 6-Minute Walk Distance (6MWD) ≥ 150 m and ≤ 500 m repeated twice during screening.\n8. Ability to adhere to study visit schedule and understand and comply with all protocol requirements.\n\nExclusion Criteria:\n\n1. PH WHO Groups 2, 3, 4 or 5.\n2. Hospitalization for any worsening medical condition or major surgery within 4 weeks prior to screening.\n3. Any symptomatic coronary disease events.\n4. History of heart transplant or on heart transplant list.\n5. Uncontrolled systemic hypertension.\n6. History of restrictive, constrictive or congestive cardiomyopathy.\n7. History of significant mitral regurgitation or aortic regurgitation valvular disease.\n8. Untreated or poorly controlled moderate or severe obstructive sleep apnea.\n9. A diagnosis of worse than moderate COPD or worse than mild ILD.\n10. Cerebrovascular event within 90 days prior to screening\n11. A pneumonectomy or lobectomy\n12. Having received an activin signaling inhibitor such as sotatercept at any time prior to screening\n13. A Hgb \\> sex-specific ULN\n14. Platelets count \\\u003C 100,000\u002Fmm3\n15. Severe (stage ≥4) renal failure with eGFR \\\u003C 30 mL\u002Fmin\u002Fm2\n16. Abnormally elevated liver function enzymes (ALT or AST \\> 3X ULN, or total bilirubin \\> 1.5X ULN).","ALL","18 Years",{"count":19,"type":20},90,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","Phase 1b\u002F2 Study of HS235 Assessing the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of the Activin Signaling Inhibitor HS235 Added to Background Treatment in Adults with Pulmonary Arterial Hypertension (PAH)",[27],"Pulmonary Arterial Hypertension","RECRUITING","2026-08-13",{"date":31,"type":32},"2026-08-17","ACTUAL",{"date":34,"type":20},"2026-08",{"date":36,"type":20},"2028-11",{"name":38,"class":39},"35Pharma Inc","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":54,"startDateStruct":55,"completionDateStruct":56,"leadSponsor":58,"locationsCount":59},"100602459","phase-1-study-of-hs235-in-obese-patients-with-pulmonary-hypertension-and-heart-failure-with-preserved-ejection-fraction-hfpef-100602459","NCT07123779","HS235 Study in Obese Participants With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (HFpEF)","Phase 1b\u002F2, Multicenter, Double-Blind, Placebo-Controlled, Multiple Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS235 in Obese Participants With Pulmonary Hypertension and HFpEF","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if they meet at least all the following criteria:\n\n1. Male or female, ≥ 18 years of age.\n2. \\[Sub-population A only - using a remote PAP sensor\\]- Ambulatory PAP monitoring (e.g., CardioMEMS™ HF System or Cordella™ HF System) implanted in the course of standard of care at least 90 days before Screening.\n\n   Hemodynamic evidence of PH with:\n   1. mPAP ≥ 25 mm Hg, as measured in supine position by the averaged 7-day values (weekly average) 2 weeks and 1 week before Randomization AND,\n   2. dPAP ≥ 15 mm Hg, as measured in supine position by the averaged 7-day values (weekly average) 2 weeks and 1 week before Randomization.\n3. \\[Sub-population B only - without a remote PAP sensor\\]\n\n   Hemodynamic evidence of PH based on the presence of all the following RHC parameters obtained during the Screening period, prior to randomization:\n   1. PVR ≥ 240 dyn\\*sec\u002Fcm5 or ≥ 3 WU, and\n   2. mPAP \\> 20 mmHg, and\n   3. PAWP \\> 15 mmHg but \\\u003C 30 mmHg, and\n   4. dPAP ≥ 15 mmHg.\n4. Established diagnosis of HFpEF with left ventricular ejection fraction (LVEF) ≥ 45 % as measured by echocardiography during Screening and and no documented LVEF \\\u003C 45% during the 2 years preceding Screening..\n5. New York Heart Association (NYHA) class II or III heart failure symptoms.\n6. Stable diuretic regimen during the screening period.\n7. Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) \\\u003C 90 at screening.\n8. 6-minute walking distance (6MWD) ≥ 100 m at screening.\n9. Body mass index ≥ 30 to ≤ 50 kg\u002Fm2 and Body weight ≤140 kg.\n10. Ability to adhere to study visit schedule and understand and comply with all protocol requirements.\n\nExclusion Criteria:\n\n1. Hospitalization for any worsening medical condition or major surgery within 4 weeks prior to screening.\n2. Occurrence of an acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery within 90 days prior to Screening.\n3. Implantation of a cardiac resynchronization therapy (CRT) device within 90 days before screening.\n4. Planned cardiovascular revascularization or planned implantation of CRT device.\n5. History of heart transplant or on heart transplant list.\n6. History of serious or life-threatening cardiac arrhythmia within 90 days prior to screening.\n7. Systemic hypotension or uncontrolled systemic hypertension.\n8. History of Pericardial constriction or hypertrophic cardiomyopathy.\n9. History of significant valvular stenosis or regurgitation.\n10. Participants with a pneumonectomy or more than moderate Chronic Obstructive Pulmonary Disease (COPD) or mild interstitial lung disease (ILD) or mild obstructive sleep apnea (OSA).",{"count":48,"type":20},126,[23,24],"Study of HS235 in Obese Participants with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction",[52,53],"Pulmonary Hypertension","Heart Failure With Preserved Ejection Fraction",{"date":31,"type":32},{"date":34,"type":20},{"date":57,"type":20},"2030-01",{"name":38,"class":39},1,""]