Prospective Cohort Study to Evaluate the Efficacy, Safety, and Tolerability of Tirzepatide in Real-World Conditions in Persons With Obesity Without Diabetes and Type 2 Diabetes Mellitus With or Without Obesity in Paraguay.
This is a prospective cohort study evaluating the efficacy, safety, and tolerability of tirzepatide under real-world conditions in the Paraguayan population. The study includes two cohorts: Cohort 1 consists of adults with obesity (BMI ≥30 kg/m²) without type 2 diabetes mellitus (T2DM), and Cohort 2 consists of adults with T2DM with or without obesity. Each cohort will enroll 80 participants (160 total). All participants will receive tirzepatide as part of their standard clinical care and will be followed for 52 weeks with visits approximately every 6 weeks. Primary outcomes include percentage change in body weight from baseline at week 52 (Cohort 1) and change in HbA1c and body weight at week 52 (Cohort 2). Safety outcomes include adverse event rates. The study is conducted at Las Rias Medical Center, Asuncion, Paraguay, and has been approved by the CEI-INCAN Ethics Committee and authorized by DINAVISA.
• Age between 18 and 70 years at the time of informed consent.
• Stable residence in Paraguay for at least 12 months prior to screening.
• Ability to provide written informed consent and comply with all study procedures.
• Sufficient proficiency in the Spanish language to complete questionnaires and follow study instructions.
• Clinical stability, defined as the absence of hospitalization related to diabetes or obesity complications within 3 months prior to screening.
• Adequate renal function, defined as an estimated glomerular filtration rate (eGFR) ≥45 mL/min/1.73m² calculated using the CKD-EPI equation.
• For participants enrolled in the obesity cohort: clinical diagnosis of obesity with BMI ≥30 kg/m², no prior diagnosis of diabetes mellitus (HbA1c \<6.5%), and at least one documented unsuccessful attempt at dietary weight-loss intervention within the previous 12 months.
• For participants enrolled in the type 2 diabetes mellitus (T2DM) cohort: established diagnosis of T2DM for at least 6 months prior to screening according to ADA 2025 criteria, HbA1c between 7.0% and 9.5% at screening confirmed at baseline, BMI ≥24 kg/m², and stable treatment on monotherapy or dual therapy with metformin, sulfonylureas, DPP-4 inhibitors, or SGLT-2 inhibitors for at least 3 months prior to screening.