A Retrospective Real-World Cohort Study

Study acronym: SCALA-TK-CM
StatusActive, Not Recruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary endpoint reworded 2 of 47 changed
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Record History

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  1. Notable Primary endpoint(s) modified
    • Lead sponsor: Novo Nordisk A/S to Novo Nordisk A/S
    • Trial status changed: Not Yet Recruiting → Active, Not Recruiting
    • Eligibility criteria expanded, about 4 words
  2. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
269 trials monitored
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and 3 more diseases
The primary objectives are to determine the prevalence and overlap of major cardiometabolic diseases, identify multimorbidity clusters, and characterize demographic, clinical, laboratory, and treatment patterns across the cohort and relevant subgroups. This study is based on anonymized electronic health record (EHR) data and spanning January 2022 to December 2025. EHR will be extracted from participants of Acibadem hospital network in Turkey. Participants received routine clinical care according to physician discretion. Index date will be defined by the first diagnosis of cardiometabolic conditions. Follow-up period will include at least one year of to allow description of long-term outcomes. It will extend until the end of study, last recorded encounter, or death.
Trial Details
NCT Number NCT07781371
Lead Sponsor Novo Nordisk A/S
Conditions
(from sponsor)
Obesity, Type 2 Diabetes (T2D), Prediabetes, Cardiovascular Disease (CVD), Dyslipidemia, Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD), Chronic Kidney Disease (CKD)
Related terms Cardiovascular Diseases, Diabetes Mellitus, Type 2, Dyslipidemias, Obesity, Prediabetic State, Renal Insufficiency, Chronic
Enrollment 100,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov