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

What this study is testing ClinicalTrials.gov NCT07588438 ↗

Description as written by the study sponsor.

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.

Treatments tested

• Tirzepatide (LIPOLESS de Laboratorio de Productos Eticos C.E.I.S.A.) also known as Dual GIP/GLP-1 Receptor Agonist Drug

  Participants will receive subcutaneous injections of tirzepatide (LIPOLESS de Laboratorio de Productos Eticos C.E.I.S.A.) once weekly. The dosage will be adjusted according to standard clinical practice and the investigator's discretion, following the manufacturer's titration schedule (starting at 2.5 mg and increasing up to 15 mg as tolerated).