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5UZ",{"type":56,"coordinates":1273},[1274,1275],0.28453,50.76871,{"lat":1275,"lon":1274},{"facility":1278,"status":454,"city":1279,"state":32,"zip":1280,"country":1252,"countryCode":1253,"cosmosGeoPoint":1281,"geoPoint":1285,"contacts":32},"Edinburgh Royal Infirmary","Edinburgh","EH16 4SA",{"type":56,"coordinates":1282},[1283,1284],-3.19648,55.95206,{"lat":1284,"lon":1283},{"facility":1287,"status":454,"city":1288,"state":32,"zip":1289,"country":1252,"countryCode":1253,"cosmosGeoPoint":1290,"geoPoint":1294,"contacts":32},"Queen Elizabeth University Hospital","Glasgow","G51 4TF",{"type":56,"coordinates":1291},[1292,1293],-4.25763,55.86515,{"lat":1293,"lon":1292},{"facility":1296,"status":454,"city":1297,"state":32,"zip":1298,"country":1252,"countryCode":1253,"cosmosGeoPoint":1299,"geoPoint":1303,"contacts":32},"St Pancras Clinical Research","London","EC2Y 8EA",{"type":56,"coordinates":1300},[1301,1302],-0.12574,51.50853,{"lat":1302,"lon":1301},{"facility":1305,"status":454,"city":1297,"state":32,"zip":1306,"country":1252,"countryCode":1253,"cosmosGeoPoint":1307,"geoPoint":1309,"contacts":32},"National Institute for Health Research (NIHR) - King's Clinical Research Facility (CRF)","SE5 9RS",{"type":56,"coordinates":1308},[1301,1302],{"lat":1302,"lon":1301},{"facility":1311,"status":454,"city":1297,"state":32,"zip":1312,"country":1252,"countryCode":1253,"cosmosGeoPoint":1313,"geoPoint":1315,"contacts":32},"Clerkenwell Health - London - Baker Street","W1U 6RP",{"type":56,"coordinates":1314},[1301,1302],{"lat":1302,"lon":1301},{"facility":1317,"status":454,"city":1318,"state":32,"zip":1319,"country":1252,"countryCode":1253,"cosmosGeoPoint":1320,"geoPoint":1324,"contacts":32},"Greater Manchester Mental Health NHS Foundation Trust","Manchester","M25 3BL",{"type":56,"coordinates":1321},[1322,1323],-2.23743,53.48095,{"lat":1323,"lon":1322},{"facility":1326,"status":454,"city":1327,"state":32,"zip":1328,"country":1252,"countryCode":1253,"cosmosGeoPoint":1329,"geoPoint":1333,"contacts":32},"Southampton General Hospital","Southampton","SO16 6YD",{"type":56,"coordinates":1330},[1331,1332],-1.40428,50.90395,{"lat":1332,"lon":1331},{"type":1335,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100609852","phase-3-a-study-of-brenipatide-in-participants-with-moderate-to-severe-alcohol-use-disorder-100609852",false,"NCT07219966","A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder","A Phase 3, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Moderate-to-Severe Alcohol Use Disorder (RENEW-ALC-1)","RENEW-ALC-1","Inclusion Criteria:\n\n* Participant must be a minimum of 20 years of age for the investigative sites in Japan.\n* Are seeking treatment and are motivated to stop or cut down on drinking.\n* Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as\n\n  * self-inject study intervention\n  * store and use the provided blinded study intervention, as directed\n  * maintain electronic and paper study diaries, as applicable, and\n  * complete the required questionnaires.\n\nExclusion Criteria:\n\n* Have evidence of current or within the past 180 days prior to screening (V1), history of any substance use disorder(s) of any severity with a pattern of persistent illicit or nonprescribed substance use as indicated by clinical interview, except alcohol, nicotine, or caffeine.\n* Have answered \"yes\" to either Question 4 or Question 5 on the \"Suicidal Ideation\" portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) and the ideation occurred within the past 6 months, or have answered \"yes\" to any of the suicide-related behaviors on the \"Suicidal Behavior\" portion of the C-SSRS and the behavior occurred within the past 6 months\n* Have either of the following:\n\n  * history of advanced liver disease, including advanced liver fibrosis \\[Stage 3\\] or cirrhosis \\[Stage 4\\], based on prior biomarkers, imaging or liver biopsy, OR\n  * history of acute alcohol-associated hepatitis based on prior liver biopsy.\n* Have participated in a clinical study and have received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening (V1).","ALL","18 Years","75 Years",{"count":1348,"type":1349},1100,"ESTIMATED","INTERVENTIONAL",[1352],"PHASE3","The purpose of this study is to see if brenipatide when compared to a placebo works and is safe for participants with moderate-to-severe Alcohol Use Disorder (AUD). Participation in this study will last approximately 56 weeks.",[1355],"Alcohol Use Disorder","2026-08-20",{"date":1358,"type":1359},"2026-08-21","ACTUAL",{"date":1361,"type":1359},"2025-10-15",{"date":1363,"type":1349},"2028-04",{"name":5,"class":6},118]