Real-world study to assess tirzepatide efficacy and safety in Paraguayan adults with obesity and type 2 diabetes

Despite the proven efficacy of novel agents like tirzepatide in controlled clinical trials, real-world data are crucial to understand their performance, safety, and tolerability in diverse populations under routine clinical care. Type 2 diabetes mellitus (T2DM) and obesity are global health challenges, and understanding how dual GLP-1 and GIP receptor agonists like tirzepatide perform in specific regional contexts, such as Paraguay, can inform local clinical guidelines and patient management strategies. This study aims to bridge the gap between trial results and practical application.

This prospective cohort study will enroll 160 adult participants across two cohorts: Cohort 1 includes 80 individuals with obesity (BMI ≥30 kg/m²) without T2DM, and Cohort 2 includes 80 individuals with T2DM (with or without obesity). All participants will receive tirzepatide as part of their standard clinical care. They will be followed for 52 weeks, with visits approximately every 6 weeks. Primary outcomes include the percentage change in body weight from baseline at week 52 for Cohort 1, and changes in HbA1c and body weight at week 52 for Cohort 2. Safety outcomes will focus on adverse event rates.

As this is a prospective study that is not yet recruiting, no findings are available. The study's primary objectives are to quantify the percentage change in body weight from baseline at week 52 in Cohort 1 (obesity without T2DM) and to measure the change in HbA1c and body weight at week 52 in Cohort 2 (T2DM with or without obesity). Secondary objectives include assessing the overall safety profile by monitoring adverse event rates throughout the 52-week follow-up period. The study aims to provide real-world data on how tirzepatide performs in a diverse Paraguayan population under routine clinical care, offering insights into its effectiveness and tolerability outside of highly controlled trial environments.