Efficacy, Safety, and Tolerability of Tirzepatide in Real-World Conditions 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.

NCT Number	NCT07588438
Lead Sponsor	Las Rías Medical Center Collaborators: LABORATORIO DE PRODUCTOS ETICOS C.E.I.S.A
Conditions	Obesity, Diabetes Mellitus, Type 2
Enrollment	160 participants
Start Date	2026-07-27
Primary Completion	2027-08-10 (estimated)
Study Completion	2027-08-10 (estimated)
Updated on ClinicalTrials.gov	2026-05-19