[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625826":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":33,"locations":39,"responsibleParty":57,"collaborators":24,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":24,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":24,"studyType":73,"phases":74,"briefSummary":77,"conditions":78,"keywords":24,"overallStatus":42,"whyStopped":24,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"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,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Richmond Pharmacology","RECRUITING","London","United Kingdom","UK",{"type":47,"coordinates":48},"Point",[49,50],-0.12574,51.50853,{"lat":50,"lon":49},[53],{"name":54,"role":36,"phone":55,"phoneExt":24,"email":56},"Study Director","+44 (0) 20 7042 5800","info@richmondpharmacology.com",{"type":58,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100625826","phase-1-study-of-tgm-312-sc01-in-healthy-participants-and-adults-with-mash-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":71,"type":72},99,"ESTIMATED","INTERVENTIONAL",[75,76],"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).",[79,80],"Healthy Participants","MASH - Metabolic Dysfunction-Associated Steatohepatitis","2026-05-18",{"date":83,"type":84},"2026-05-19","ACTUAL",{"date":86,"type":84},"2026-03-03",{"date":88,"type":72},"2028-06",{"name":5,"class":6},1]