[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651116":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":44,"locations":51,"responsibleParty":137,"collaborators":139,"id":143,"slug":144,"hasResults":145,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":145,"sex":151,"minAge":152,"maxAge":153,"enrollmentInfo":154,"targetDuration":49,"studyType":157,"phases":158,"briefSummary":160,"conditions":161,"keywords":165,"overallStatus":169,"whyStopped":49,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"fullName":5,"class":6},"University of North Carolina, Chapel Hill","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tirzepatide","EXPERIMENTAL","Treatment will start at 2.5 mg once weekly. After 4 weeks, the dose will be increased to 5 mg once weekly. After another 4 weeks, the dose will be increased to 7.5 mg once weekly for 4 weeks.",[13],"Drug: Tirzepatide",{"label":15,"type":16,"description":17,"interventionNames":18},"Optimized Standard of Care anti-diarrheal therapy","ACTIVE_COMPARATOR","Optimized regimen of loperamide 2 mg orally every 6 hours as needed for increased frequency or diphenoxylate\u002Fatropine can be given 2 mg orally every 6 hours. When using either or both therapies in combination the participant should not exceed a maximum dose of 16 mg orally within 24 hours. For participants with continued or worsening high bowel frequency for \\>2 weeks, transition to active therapy with tirzepatide will be offered at week 4. Tirzepatide treatment would begin as 2.5 mg once weekly. After 4 weeks, the dose will be increased to 5 mg once weekly. After another 4 weeks, the dose will be increased to 7.5 mg once weekly for 4 weeks.",[13,19,20],"Drug: Loperamide","Drug: Diphenoxylate\u002FAtropine",[22,28,34],{"type":23,"name":9,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Tirzepatide will be administered subcutaneously",[15,9],[27],"Zepbound",{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Loperamide","2 mg orally every 6 hours as needed",[15],[33],"Imodium",{"type":23,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Diphenoxylate\u002FAtropine","2 mg orally every 6 hours",[15],[39],"Lomotil",[41],{"name":42,"affiliation":5,"role":43},"Edward Barnes, MD","PRINCIPAL_INVESTIGATOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},"Mikki Sandridge","CONTACT","919-843-3873",null,"mikki_sandridge@med.unc.edu",[52,72,89,106,120],{"facility":53,"status":49,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Cedars Sinai Medical Center","Beverly Hills","California","90211","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-118.40036,34.07362,{"lat":63,"lon":62},[66,70],{"name":67,"role":47,"phone":68,"phoneExt":49,"email":69},"Melissa Myers","310-423-0035","Melissa.Myers@cshs.org",{"name":71,"role":43,"phone":49,"phoneExt":49,"email":49},"Andres Yarur, MD",{"facility":73,"status":49,"city":74,"state":75,"zip":76,"country":57,"countryCode":58,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Mayo Clinic","Rochester","Minnesota","55905",{"type":60,"coordinates":78},[79,80],-92.4699,44.02163,{"lat":80,"lon":79},[83,87],{"name":84,"role":47,"phone":85,"phoneExt":49,"email":86},"Chad Rypstra","507-538-4289","Rypstra.Chad@mayo.edu",{"name":88,"role":43,"phone":49,"phoneExt":49,"email":49},"Laura Raffals, MD",{"facility":90,"status":49,"city":91,"state":92,"zip":93,"country":57,"countryCode":58,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Washington University School of Medicine","St Louis","Missouri","63110",{"type":60,"coordinates":95},[96,97],-90.19789,38.62727,{"lat":97,"lon":96},[100,104],{"name":101,"role":47,"phone":102,"phoneExt":49,"email":103},"Katherine Huang","314-273-0301","luluhuang@wustl.edu",{"name":105,"role":43,"phone":49,"phoneExt":49,"email":49},"Parakkal Deepak, MD",{"facility":107,"status":49,"city":108,"state":109,"zip":110,"country":57,"countryCode":58,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"University of North Carolina","Chapel Hill","North Carolina","27599",{"type":60,"coordinates":112},[113,114],-79.05584,35.9132,{"lat":114,"lon":113},[117,118],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},{"name":119,"role":43,"phone":49,"phoneExt":49,"email":49},"Edward Barnes, MD, MPH",{"facility":121,"status":49,"city":122,"state":123,"zip":124,"country":57,"countryCode":58,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"University of Utah","Salt Lake City","Utah","84112",{"type":60,"coordinates":126},[127,128],-111.89105,40.76078,{"lat":128,"lon":127},[131,135],{"name":132,"role":47,"phone":133,"phoneExt":49,"email":134},"Lynette Holman","801-585-9155","Lynette.holman@hsc.utah.edu",{"name":136,"role":43,"phone":49,"phoneExt":49,"email":49},"Priscila Santiago, MD",{"type":138,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR",[140],{"name":141,"class":142},"Eli Lilly and Company","INDUSTRY","100651116","tirzepatide-for-ileal-pouch-anal-anastomosis-ipaa-and-chronic-high-bowel-frequency-i8f-ns-x008-100651116",false,"NCT07756359","Tirzepatide for Ileal Pouch-anal Anastomosis (IPAA) and Chronic High Bowel Frequency (I8F-NS-X008)","Efficacy of the Dual GIP - GLP-1 Receptor Agonist Tirzepatide in Patients With an Ileal Pouch-anal Anastomosis (IPAA) and Chronic High Bowel Frequency (I8F-NS-X008)","PROP-ZEP","Inclusion Criteria:\n\n* Informed consent will be obtained before any study-related procedures\n* Age \\> 18 and \\\u003C80 years\n* Patients with an IPAA and bowel frequency \\> 8 bowel movements in 24 hours on at least 4 of 7 days\u002Fweek (and\u002For an average of \\>8 bowel movements in the 7 days preceding enrollment)\n\n  * Patients must have demonstrated high bowel frequency despite adequate therapy for high bowel frequency with loperamide 2 mg orally every 6 hours as needed (at least 3 doses daily) and\u002For diphenoxylate\u002Fatropine 2 mg orally every 6 hours as needed (at least 3 doses daily) or proven intolerance to these anti-diarrheal medications.\n  * Among patients with inflammatory conditions of the pouch, high bowel frequency must be demonstrated despite adequate therapy for intermittent pouchitis, chronic pouchitis, or Crohn's like disease of the pouch. Adequate therapy is required to ensure significant pouch inflammation is not a driver of high bowel frequency (described in Exclusion Criteria).\n* Participants with a proven history of ulcerative colitis and history of 1,2, modified -2 or 3 stage IPAA and ileostomy takedown\n* Ability to access internet for electronic database entry\n\nExclusion Criteria:\n\n* Prior exposure to tirzepatide or other GLP-1RA\n* BMI \\\u003C20 at the time of study screening\n* Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2\n* Known hypersensitivity to tirzepatide or its metabolites\n* Significant pouch inflammation defined as an endoscopic pouch disease activity index (PDAI ) ≥ 4\n* Known stricture of the ileo-anal anastomosis or afferent limb stricture\n* New onset of high bowel frequency in the setting of acute pouchitis\n* Final stage of IPAA surgery \\\u003C 6 months prior to enrollment\n* Current infection with Clostridioides difficile\n* Known HIV or active Hepatitis B\u002FC\n* Clinically significant liver disease (Primary Sclerosing Cholangitis with LFT's \\\u003C1.5 upper limit of normal can be included)\n* Severe hepatic impairment, defined as Child-Pugh Class C\n* Known clinically significant chronic nausea and\u002For vomiting in the past\n* Known diagnosis of type 1 or type 2 diabetes\n* Known decreased kidney function with a glomerular filtration rate \\\u003C30 ml\u002Fmin\u002F1.732\n* History of malignancy, except for basal cell carcinoma, non-metastatic squamous cell carcinoma of the skin, or prior malignancy with curative therapy completed at least 5 years prior to screening and no recurrence.\n* New York Heart Association class 3 or greater heart failure or recent (within 6 months) cardiovascular event\n* Prior history of pancreatitis\n* Clinically significant laboratory results at screening or baseline, as judged by the Investigator from local testing.\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.\n* Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening.\n* Any disorder, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.","ALL","18 Years","80 Years",{"count":155,"type":156},20,"ESTIMATED","INTERVENTIONAL",[159],"PHASE4","The goal of this clinical trial is to learn if Tirzepatide (Zepbound) can decrease bowel frequency in patients that have an ileal-pouch anal anastomosis (IPAA or pouch) better than standard of care anti-diarrheal therapy.\n\nThe main question it aims to answer is:\n\nDoes Tirzepatide reduce bowel frequency better than standard of care anti-diarrheal therapy in patients that have a pouch\n\nParticipants will:\n\nVisit the clinic 5 times, answer questions about symptoms daily, be assigned to take the study product as instructed and provide a stool sample 4 times.",[162,163,164],"Pouch, Ileal","Pouches, Ileoanal","Bowel Diseases, Inflammatory",[166,167,168],"High Bowel Frequency","IPAA","ileal pouch-anal anastomosis","NOT_YET_RECRUITING","2026-08-04",{"date":172,"type":173},"2026-08-10","ACTUAL",{"date":175,"type":156},"2026-09",{"date":177,"type":156},"2027-09",{"name":5,"class":6},5]