nctId: NCT06383390 id: 18584 id: J1I-MC-GZBO type: OTHER domain: Eli Lilly and Company id: 2023-508630-34-00 type: OTHER domain: EU CTR Number briefTitle: The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Renal Function in Adults Living With Obesity (TRIUMPH-OUTCOMES) overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2029-02 date: 2029-02 date: 2024-04-25 date: 2024-04-25 name: Eli Lilly and Company class: INDUSTRY briefSummary: The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function. The trial will enroll adults with body mass index 27 kg/m\^2 or higher and Atherosclerotic Cardiovascular Disease and/or chronic kidney disease. conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 10000 type: ESTIMATED name: Retatrutide name: Placebo measure: Time to First Occurrence of Composite Endpoints measure: Time to First Occurrence of Composite Endpoint of End Stage Kidney Disease (ESKD), ≥ 40% Sustained Decline in Estimated Glomerular Filtration Rate (eGFR), CV Death or Renal Death measure: Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events (MACE-3) measure: Time to First Occurrence of Composite Endpoint of CV death, or hospitalization or urgent visit due to HF measure: Time to Occurrence of All-Cause Death measure: Time to First Occurrence of composite endpoint of ≥ 40% Sustained Decline in eGFR, End-Stage Renal Disease (ESRD), or Renal Death measure: Percentage change from Baseline in Albuminuria urinary albumin/creatinine ratio (UACR) in Participants with UACR ≥30 mg/g (0.03 mg/mg) at baseline sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Central Research Associates city: Birmingham state: Alabama zip: 35205 country: United States name: David D. 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