[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560878":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":29,"locations":39,"responsibleParty":59,"collaborators":61,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":28,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":28,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":42,"whyStopped":28,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tirzepatide","EXPERIMENTAL","To minimize the risk of gastrointestinal adverse events, we will use a standard dose-escalation regimen for tirzepatide (placebo-matched), starting at 2.5 mg once weekly (OW) at randomization. After 4 weeks of treatment at 2.5 mg, the dose will be escalated to 5 mg OW, which will be maintained for another 4 weeks and then continued as the target dose for 10 months until the end of treatment. As with other nutrient stimulating hormone (NuSH) therapies, dose reductions and extensions of dose-escalation intervals will be permitted if participants experience unacceptable adverse events. The minimum tolerated dose required for continued study participation is 2.5 mg\u002Fweek. All dose changes will be documented in the study records.",[13],"Drug: Tirzepatide",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Other: Placebo",[20,26],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Titrated to dose of 5 mg once weekly subcutaneous",[9],[25],"Zepbound",{"type":6,"name":15,"description":22,"armGroupLabels":27,"otherNames":28},[15],null,[30,35],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},"Kristen Nowak, PhD, MPH","CONTACT","3037244842","Kristen.Nowak@cuanschutz.edu",{"name":36,"role":32,"phone":37,"phoneExt":28,"email":38},"Diana George","303-724-1684","Diana.George@cuanschutz.edu",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"University of Colorado - Anschutz Medical Campus","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-104.83192,39.72943,{"lat":52,"lon":51},[55,57],{"name":31,"role":32,"phone":56,"phoneExt":28,"email":34},"303-724-4842",{"name":31,"role":58,"phone":28,"phoneExt":28,"email":28},"PRINCIPAL_INVESTIGATOR",{"type":60,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[62,64,66],{"name":63,"class":6},"Washington University School of Medicine",{"name":65,"class":6},"Mayo Clinic",{"name":67,"class":68},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100560878","phase-2-glucagon-like-peptide-1-receptor-agonist-in-adpkd-100560878",false,"NCT06582875","Glucagon-Like Peptide-1 Receptor Agonist in ADPKD","Advancing ADPKD Treatment With GLP-1RA: A Study of Glucagon-Like Peptide-1 Receptor Agonists' Efficacy, Safety, and Mechanism","Inclusion Criteria:\n\n* 18-65 years of age\n* ADPKD diagnosis based on the modified Pei-Ravine criteria\n* Body-mass index of ≥27 kg\u002Fm\\^2\n* Estimated glomerular filtration rate ≥ 30 mL\u002Fmin\u002F1.73m\\^2\n* Mayo Classification of C, D, or E, calculated from a previous kidney ultrasound or MRI performed within the last 12 months\n* Not currently participating in or planning to participate in any formal weight loss or physical activity program, or another interventional study\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Diabetes mellitus\n* Tolvaptan usage or plans to initiate tolvaptan\n* History of hospitalization or major surgery within the last 3 months\n* Uncontrolled hypertension (systolic blood pressure \\> 160 or diastolic blood pressure \\>100 mm Hg)\n* Pregnancy, lactation, or unwillingness to use adequate birth control\n* Regular use of prescription or over-the-counter medications that may affect weight, appetite, food intake, or energy metabolism\n* History of clinically diagnosed eating disorder including: anorexia nervosa, bulimia, binge eating disorder\n* Weight change of \\>5% in the past 3 months for any reason except post-partum weight loss\n* Inability to cooperate with or clinical contraindication for MRI including: severe claustrophobia, implants, devices, or non-removable body piercings\n* Presence or personal history of malignant neoplasm within 5 years prior to the day of screening\n* Personal or family history of medullary thyroid carcinoma, thyroid nodule, or multiple endocrine neoplasia type 2\n* Prior history of pancreatitis\n* Weight ≥450 lb","ALL","18 Years","65 Years",{"count":80,"type":81},126,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","The proposed clinical trial aims to assess if a year of treatment with a glucagon-like peptide 1 receptor agonist, a medication approved for weight management that also improves the body's response to glucose and insulin, can slow kidney growth in adults with autosomal dominant polycystic kidney disease who are overweight or obese. The study will also evaluate changes in abdominal fat and kidney metabolism using cutting-edge images techniques. Blood and urine samples will provide further insight into biological changes that may be linked to the benefits of the intervention, while ensuring careful monitoring of safety and tolerability.",[87,88],"Autosomal Dominant Polycystic Kidney","Obesity",[90],"GLP1RA","2025-05-05",{"date":93,"type":94},"2025-05-06","ACTUAL",{"date":96,"type":94},"2025-03-06",{"date":98,"type":81},"2029-06-30",{"name":5,"class":6},1]