[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625826":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":33,"locations":39,"responsibleParty":56,"collaborators":24,"id":58,"slug":24,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":24,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":24,"studyType":71,"phases":72,"briefSummary":75,"conditions":76,"keywords":24,"overallStatus":42,"whyStopped":24,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Tangram Therapeutics Plc","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TGM-312-SC01","EXPERIMENTAL","Participants will receive study treatment according to the assigned intervention.",[13],"Drug: TGM-312-SC01",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","TGM-312-SC01 is an investigational medicinal product administered by subcutaneous injection according to a protocol-defined regimen.",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Placebo administered by subcutaneous injection according to a protocol-defined regimen.",[15],[29],{"name":30,"affiliation":31,"role":32},"Sponsor Medical Representative","Tangram Therapeutics","STUDY_DIRECTOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},"Sponsor Clinical Trials Office","CONTACT","+44 20 4558 3826","clinicaltrials@tangramtx.com",[40],{"facility":41,"status":42,"city":43,"state":24,"zip":24,"country":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Richmond Pharmacology","RECRUITING","London","United Kingdom",{"type":46,"coordinates":47},"Point",[48,49],-0.12574,51.50853,{"lat":49,"lon":48},[52],{"name":53,"role":36,"phone":54,"phoneExt":24,"email":55},"Study Director","+44 (0) 20 7042 5800","info@richmondpharmacology.com",{"type":57,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100625826",false,"NCT07427680","Study of TGM-312-SC01 in Healthy Participants and Adults With MASH","RESTORE-MASH: A Phase 1\u002F2 Randomized, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of TGM-312-SC01 in Healthy Participants and Adults With MASH","Inclusion Criteria:\n\n* Adults aged 18 to 70 years who are able to provide written informed consent.\n* Medically suitable for study participation based on protocol-defined assessments.\n* For the disease cohort, participants with clinical features consistent with metabolic dysfunction-associated steatohepatitis, as defined in the protocol.\n\nExclusion Criteria:\n\n* Clinically significant medical conditions, laboratory abnormalities, or other findings that, in the opinion of the investigator, could increase risk, interfere with study participation, or confound interpretation of study results.\n* Recent participation in another investigational study.\n* Use of medications that are prohibited by the protocol.\n* Any other condition that would make the individual unsuitable for study participation as determined by the investigator.",true,"ALL","18 Years","70 Years",{"count":69,"type":70},99,"ESTIMATED","INTERVENTIONAL",[73,74],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) effects of single ascending doses of TGM-312-SC01 in healthy adults and multiple ascending doses in patients with metabolic dysfunction-associated steatohepatitis (MASH).",[77,78],"Healthy Participants","MASH - Metabolic Dysfunction-Associated Steatohepatitis","2026-05-18",{"date":81,"type":82},"2026-05-19","ACTUAL",{"date":84,"type":82},"2026-03-03",{"date":86,"type":70},"2028-06",{"name":5,"class":6},1]