[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metabolic-comorbidities\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metabolic-comorbidities":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100655334","early-phase-1-tirzepatide-and-levonorgestrel-iud-therapy-for-ein-and-early-stage-endometrial-cancer-100655334",false,"NCT07812636","Tirzepatide and Levonorgestrel IUD Therapy for EIN and Early-Stage Endometrial Cancer","Combination Tirzepatide and Levonorgestrel Intrauterine Device Therapy for Endometrial Intraepithelial Neoplasia (EIN) and Grade 1 Endometrioid Endometrial Carcinoma: A Pilot Window-of-Opportunity Study","TIDE","Inclusion\n\n1. Age ≥ 18 years\n2. Histologically confirmed endometrial intraepithelial neoplasia (EIN) or grade 1 endometrioid EC\n3. BMI ≥ 30 kg\u002Fm2\n4. Presence of at least one obesity-associated metabolic comorbidity, including:\n\n   a. Hypertension defined as: i. Documented diagnosis of hypertension, regardless of treatment status, documented in the medical records, or ii. Participants receiving antihypertensive therapy, or iii. BP ≥ 130\u002F80 mmHg over 3 independent measurements, or iv. Single BP ≥ 160\u002F100 mmHg b. Hyperlipidemia defined as: i. Documented diagnosis of hyperlipidemia, regardless of treatment status, documented in the medical record, or ii. Participants receiving lipid-lowering therapy, or iii. Triglycerides \\> 200 mg\u002FdL, or iv. LDL Cholesterol \\> 130 mg\u002FdL c. Type 2 Diabetes defined as: i. Documented diagnosis of Type 2 diabetes mellitus, regardless of treatment status, documented in the medical record, or ii. Receiving glucose-lowering therapy, or iii. Impaired glucose tolerance (Hgb A1c \\> 6.0%) d. Diagnosed with sleep apnea\n5. For participants diagnosed with grade 1 endometrioid endometrial carcinoma: clinical stage 1A disease with MRI-confirmed myometrial invasion \\\u003C 50% and no evidence of metastatic disease\n6. For participants with EIN: no evidence of extrauterine disease based on clinically appropriate evaluation\n7. Ability to provide informed consent and comply with study procedures and follow-up\n\nExclusion\n\n1. Mismatch repair-deficient (MMRd) tumors\n2. p53-abnormal tumors\n3. Known hypersensitivity or contraindication to either:\n\n   1. Tirzepatide, or\n   2. LNG-IUD\n4. Prior LNG-IUD in place at the time of EIN or endometrial cancer diagnosis\n5. Current systemic progestin therapy\n6. Current treatment with tirzepatide or another GLP-1 receptor agonist\u002FGLP-1-GIP receptor agonist, or prior treatment with these agents within 1 month before study enrollment\n7. Type 1 diabetes or a history of pancreatitis, medullary thyroid carcinoma, or Multiple Endocrine Neoplasia syndrome type 2 (MEN2)\n8. Pregnancy, breastfeeding, or intention to become pregnant during the study treatment\n9. Concurrent malignancy requiring active treatment (except non-melanoma skin cancer)\n10. Any medical, psychiatric, or social condition, that in the opinion of the investigator, would interfere with study participation or safety\n11. Participants with diabetic eye disease, including non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema\n12. Severe renal impairment, defined as eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m2","FEMALE","18 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","This single-arm study will evaluate the feasibility, safety, and preliminary efficacy of tirzepatide in combination with standard levonorgestrel intrauterine device (LNG-IUD) therapy in patients with endometrial intraepithelial neoplasia (EIN) or grade 1 endometrioid endometrial carcinoma with co-existing obesity and metabolic risk factors. Participants will receive tirzepatide once weekly while continuing standard clinical management with an LNG-IUD. Treatment decisions will remain at the discretion of the treating physician. The primary objective is to evaluate pathologic response at approximately 6 months. Secondary objectives include changes in metabolic parameters, assessing the incidence and severity of adverse events of tirzepatide and LNG-IUD therapy, quality of life assessment, change in weight, and change in BMI.",[27,28,29],"Grade 1 Endometrial Endometrioid Carcinoma","Endometrial Intraepithelial Neoplasia","Metabolic Comorbidities",[31,32],"Tirzepatide","LNG-IUD","NOT_YET_RECRUITING","2026-09-04",{"date":36,"type":37},"2026-09-10","ACTUAL",{"date":39,"type":21},"2026-11-01",{"date":41,"type":21},"2028-08-01",{"name":43,"class":44},"Milton S. Hershey Medical Center","OTHER"]