[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653176":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":35,"studyPopulation":35,"armGroups":45,"interventions":52,"overallOfficials":60,"centralContacts":64,"locations":70,"responsibleParty":87,"collaborators":89,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":95,"sex":101,"minAge":102,"maxAge":35,"enrollmentInfo":103,"targetDuration":35,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":35,"overallStatus":112,"whyStopped":35,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"University of Chicago","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":35},[9,13,16,19,22],{"measure":10,"description":11,"timeFrame":12},"Body weight changes","To assess the effect of tirzepatide, on change in body weight in patients taking lorlatinib.","1 year post treatment start",{"measure":14,"description":15,"timeFrame":12},"Lipid changes","To assess the effect of tirzepatide on change in lipid profile High-density lipoprotein (HDL), low-density lipoprotein (LDL), total cholesterol, triglycerides) at 52 weeks compared to baseline.",{"measure":17,"description":18,"timeFrame":12},"Change in Cmax","Determine if the peak concentration of Lorlatinib is significantly altered when co-administered with tirzepatide.",{"measure":20,"description":21,"timeFrame":12},"Change in Tmax","Assess if the time to peak concentration is delayed due to tirzepatide's effect on gastric emptying.",{"measure":23,"description":24,"timeFrame":12},"Bioavailability","Evaluate partial AUC to estimate the extent of drug absorption.",[26,30,33,36],{"measure":27,"description":28,"timeFrame":29},"Rate of metabolic side effects","Number of Common Terminology Criteria for Adverse Events (CTCAE) Grade 1-3 metabolic side effects","1 year from start of treatment",{"measure":31,"description":32,"timeFrame":29},"Changes in body mass composition","Changes in body mass will be measured using Bioelectrical Impedance Analysis (BIA).",{"measure":34,"description":35,"timeFrame":29},"Changes in waist circumference",null,{"measure":37,"description":38,"timeFrame":29},"Changes in cardiometabolic markers","The number of participants that experience a change in cardiometabolic markers will be reported. This includes changes in blood tests for any of the following: Hemoglobin A1c (HbA1c), insulin, glucose, Apolipoprotein B (ApoB), homocysteine, C-reactive protein (CRP), and lipoprotein(a) (Lp(a))",{"allocation":40,"interventionModel":41,"interventionModelDescription":35,"primaryPurpose":42,"observationalModel":35,"timePerspective":35,"maskingInfo":43},"NA","SINGLE_GROUP","TREATMENT",{"masking":44,"maskingDescription":35,"whoMasked":35},"NONE",[46],{"label":47,"type":48,"description":49,"interventionNames":50},"Tirzepatide Treatment","EXPERIMENTAL","Individuals taking with an body mass index (BMI) in obese range (BMI greater than or equal to 30) or those with a BMI greater than or equal to 27 and with cardiac risk factors will receive tirzepatide starting after study enrollment.\n\nIndividuals that do not meet these BMI criteria will start tirzepatide if they experience weight gain of 5% of more during the study.\n\nStatistical analysis will include all participants that receive tirzepatide on this study.",[51],"Drug: Tirzepatide",[53],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"DRUG","Tirzepatide","Participants will receive tirzepatide with weekly subcutaneous injections at 2.5 mg, following a structured dose escalation protocol over 20 weeks to reach the target dose of 15 mg per week or the maximum tolerated dose.",[47],[59],"Monjouro, Zepbound",[61],{"name":62,"affiliation":5,"role":63},"Marina Garassino","PRINCIPAL_INVESTIGATOR",[65],{"name":66,"role":67,"phone":68,"phoneExt":35,"email":69},"Clinical Trials Intake Intake","CONTACT","855-702-8222","cancerclinicaltrials@bsd.uchicago.edu",[71],{"facility":72,"status":35,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"University of Chicago Medicine Comprehensive Cancer Center","Chicago","Illinois","60637","United States","US",{"type":79,"coordinates":80},"Point",[81,82],-87.65005,41.85003,{"lat":82,"lon":81},[85],{"name":86,"role":67,"phone":68,"phoneExt":35,"email":69},"Clinical Trials Intake",{"type":88,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[90],{"name":91,"class":92},"Pfizer","INDUSTRY","100653176","phase-1-impact-of-using-a-glp1-on-treatment-related-side-effects-of-lung-cancer-patients-receiving-lorlatinib-100653176",false,"NCT07782359","Impact of Using a GLP1 on Treatment Related Side Effects of Lung Cancer Patients Receiving Lorlatinib","Impact of Tirzepatide on Lorlatinib-Associated Weight Gain and Metabolic Derangements in Patients With Non-Small Cell Lung Cancer (NSCLC)","NSCLC","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Receiving lorlatinib as first-line treatment for advanced NSCLC ALK-positive, already prescribed and administered by the patient's treating oncologist as standard of care at the time of study enrollment. This study does not initiate lorlatinib therapy or assign lorlatinib dosing; participants must already be receiving lorlatinib prior to enrollment\n\nExclusion Criteria:\n\n* Known hypersensitivity to GLP-1 agonists.\n* Active, unstable psychiatric illness; current suicidal ideation\n* Severe organ dysfunction or systemic illness.\n* Anorexia nervosa\n* History of pancreatitis\n* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2\n* Current use of Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RA) or glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) \\[GLP-1 RA\u002FGIP\\] co-agonist use within the last 90 days prior to screening\n* Current anti-obesity medication use (other than GLP-1 RA) or dipeptidyl peptidase-4 (DPP4) inhibitor use or use within the last 30 days prior to screening\n* Pregnant, breastfeeding or planning pregnancy","ALL","18 Years",{"count":104,"type":105},30,"ESTIMATED","INTERVENTIONAL",[108],"PHASE1","The proposed study seeks to address a critical gap in the management of lorlatinib-induced metabolic derangements, particularly rapid weight gain, which can adversely affect treatment adherence, dosing and ultimately patient outcomes. In this study patients with non-small cell lung cancer (NSCLC) receiving lorlatinib treatment will receive tirzepatide, a dual GIP\u002FGLP-1 receptor agonist with demonstrated efficacy in weight reduction and metabolic improvement. This study seeks to evaluate its potential to mitigate side effects while preserving the therapeutic efficacy of lorlatinib.",[111],"Lung Cancer","NOT_YET_RECRUITING","2026-08-20",{"date":115,"type":116},"2026-08-24","ACTUAL",{"date":118,"type":105},"2026-10",{"date":120,"type":105},"2030-06",{"name":5,"class":6},1]