[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600780":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":36,"centralContacts":41,"locations":47,"responsibleParty":126,"collaborators":128,"id":132,"slug":133,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":134,"sex":140,"minAge":141,"maxAge":142,"enrollmentInfo":143,"targetDuration":36,"studyType":146,"phases":147,"briefSummary":149,"conditions":150,"keywords":153,"overallStatus":50,"whyStopped":36,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},{"fullName":5,"class":6},"Actimed Therapeutics Ltd","INDUSTRY",[8,16,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1 semaglutide, low dose ACM-001.1 or sham injection\u002Fplacebo during semaglutide therapy PROACT 1","ACTIVE_COMPARATOR","Patients in Arm 1 will be randomized to a crossover design, to receive either semaglutide and low dose ACM-001.1 BID or a sham injection and placebo ACM-001.1 BID during Period 1. Following washout, in Period 2 patients within Arm 1 and Arm 2 will cross-over onto the opposing treatment.",[13,14,15],"Drug: (S)-pindolol benzoate","Drug: Semaglutide","Drug: Placebo to (S)-pindolol benzoate",{"label":17,"type":10,"description":18,"interventionNames":19},"Arm 2 semaglutide, high dose ACM-001.1 or sham injection\u002Fplacebo during semaglutide therapy PROACT 1","Patients in Arm 2 will be randomized to a crossover design, to receive either semaglutide and high dose ACM-001.1 BID (Group 2a) or a sham injection and placebo ACM-001.1 BID (Group 2b) during Period 1. Following washout, in Period 2 patients within Arm 1 and Arm 2 will cross-over onto the opposing treatment.",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"Arm 3 ACM-001.1 low dose, high dose or placebo following semaglutide therapy PROACT 2","Patients randomized to Arm 3 will receive semaglutide and placebo ACM-001.1 BID during Period 1. Patients in Arm 3 will be further randomised into one of three treatment groups for Period 2:\n\nGroup 3a will receive a sham injection and low dose ACM-001.1 BID Group 3b will receive a sham injection and high dose ACM-001.1 BID Group 3c will receive a sham injection and Placebo ACM-001.1 BID",[13,14,15],[25,32,37],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","(S)-pindolol benzoate","(S)-pindolol benzoate (ACM-001.1) immediate release tablet containing (S)-pindolol benzoate administered BID.",[9,17,21],[31],"ACM-001.1",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Semaglutide","Semaglutide, solution for injection in pre-filled pen",[9,17,21],null,{"type":26,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Placebo to (S)-pindolol benzoate","Placebo to ACM-001.1 immediate release tablet administered BID",[9,17,21],[42],{"name":43,"role":44,"phone":45,"phoneExt":36,"email":46},"Fabio Dorigotti, MD","CONTACT","+41 79 653 55 67","info@actimedtherapeutics.com",[48,63,74,82,93,104,115],{"facility":49,"status":50,"city":51,"state":36,"zip":36,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Clinical Hospital Center 'Dr Dragisa Misovic - Dedinje'","RECRUITING","Belgrade","Serbia","RS",{"type":55,"coordinates":56},"Point",[57,58],20.46513,44.80401,{"lat":58,"lon":57},[61],{"name":62,"role":44,"phone":36,"phoneExt":36,"email":36},"Vladan Vukomanovic, Dr.",{"facility":64,"status":50,"city":51,"state":36,"zip":36,"country":52,"countryCode":53,"cosmosGeoPoint":65,"geoPoint":67,"contacts":68},"Clinical Hospital Center Bezanijska kosa",{"type":55,"coordinates":66},[57,58],{"lat":58,"lon":57},[69,71],{"name":70,"role":44,"phone":36,"phoneExt":36,"email":36},"Marija Zdravkovic, Prof. Dr.",{"name":72,"role":73,"phone":36,"phoneExt":36,"email":36},"Marija Zdravkovic, Prof. Dr","PRINCIPAL_INVESTIGATOR",{"facility":75,"status":50,"city":51,"state":36,"zip":36,"country":52,"countryCode":53,"cosmosGeoPoint":76,"geoPoint":78,"contacts":79},"University Clinical Center of Serbia",{"type":55,"coordinates":77},[57,58],{"lat":58,"lon":57},[80],{"name":81,"role":44,"phone":36,"phoneExt":36,"email":36},"Vesna Dimitrijevic Sreckovic, Prof. Dr.",{"facility":83,"status":50,"city":84,"state":36,"zip":36,"country":52,"countryCode":53,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"University Clinical Center Kragujevac","Kragujevac",{"type":55,"coordinates":86},[87,88],20.91667,44.01667,{"lat":88,"lon":87},[91],{"name":92,"role":44,"phone":36,"phoneExt":36,"email":36},"Miodrag Sreckovic, Dr.",{"facility":94,"status":50,"city":95,"state":36,"zip":36,"country":52,"countryCode":53,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Klinika Za Endocrinologiju, Dijabetes I Bolesti Metabolizma","Niš",{"type":55,"coordinates":97},[98,99],21.90333,43.32472,{"lat":99,"lon":98},[102],{"name":103,"role":44,"phone":36,"phoneExt":36,"email":36},"Sasa Radenkovic, Dr.",{"facility":105,"status":50,"city":106,"state":36,"zip":36,"country":52,"countryCode":53,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"University Clinical Center of Vojvodina","Novi Sad",{"type":55,"coordinates":108},[109,110],19.83694,45.25167,{"lat":110,"lon":109},[113],{"name":114,"role":44,"phone":36,"phoneExt":36,"email":36},"Milena Mitrovic, Prof. Dr.",{"facility":116,"status":50,"city":117,"state":36,"zip":36,"country":52,"countryCode":53,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Opsta bolnica Pancevo","Pančevo",{"type":55,"coordinates":119},[120,121],20.64167,44.87177,{"lat":121,"lon":120},[124],{"name":125,"role":44,"phone":36,"phoneExt":36,"email":36},"Ana Kovacevic Kuzmanovic, Dr.",{"type":127,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[129],{"name":130,"class":131},"SCIRENT Clinical Research and Science d.o.o.","UNKNOWN","100600780","phase-2-a-study-of-the-effect-of-s-pindolol-benzoate-acm-0011-on-lean-body-mass-lbm-in-obese-patents-during-proact-1-and-post-semaglutide-therapy-proact-2-100600780",false,"NCT07101939","A Study of the Effect of (S)-Pindolol Benzoate (ACM-001.1) on Lean Body Mass (LBM) in Obese Patents During (PROACT 1), and Post-semaglutide Therapy (PROACT 2)","A Two-part, Phase 2a Randomized, Part Parallel-group, Double-blind Placebo-controlled Cross-over Multi-center Study to Evaluate the Effect of Two Dose Levels of (S)-Pindolol Benzoate (ACM-001.1) on Lean Body Mass in Obese Patients During (PROACT 1), and Post-semaglutide Therapy (PROACT 2)","PROACT","Key Inclusion Criteria:\n\nEligible for treatment with semaglutide.\n\nHave a BMI of ≥30.0 kg\u002Fm².\n\nKey Exclusion Criteria:\n\nType 2 diabetes mellitus who in the preceding 90 days have either:\n\n* received a GLP-1RA (including semaglutide),\n* had a hypoglycaemic event,\n* lost \\>5 kg weight,\n* had a HBA1C over 10.0%.\n\nAny cardiovascular event within previous 6 months, uncontrolled hypertension, known congestive heart failure, or angina during the past year\n\nKnown severe chronic obstructive pulmonary disease (COPD)\n\nConcomitant use of beta blockers and patients with contra indications to beta blockers","ALL","18 Years","75 Years",{"count":144,"type":145},120,"ESTIMATED","INTERVENTIONAL",[148],"PHASE2","Semaglutide is approved for weight management (weight loss and weight maintenance) in adult obese patients. Drug treatments like semaglutide that result in weight-loss can also decrease muscle mass. The purpose of this study is to investigate the effect of ACM-001.1 (the study drug) on how much muscle is lost when a person takes it with semaglutide (PROACT 1) and how much muscle mass is gained when a person continues taking ACM-001.1 but stops taking semaglutide (PROACT 2).",[151,152],"Obesity","Muscle Loss",[154,155,156,157,158,159],"semaglutide","s-pindolol","obesity","glp-1","glucagon-like peptide-1 receptor agonist","lean body mass","2026-02-13",{"date":162,"type":163},"2026-02-17","ACTUAL",{"date":165,"type":163},"2025-06-23",{"date":167,"type":145},"2027-03",{"name":5,"class":6},7]