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

Study acronym: REAL-TIRZEPY
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened
    • Site details revised
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Las Rías Medical Center
1 trial monitored
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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.
Trial Details
NCT Number NCT07588438
Lead Sponsor Las Rías Medical Center
Collaborators: LABORATORIO DE PRODUCTOS ETICOS C.E.I.S.A
Conditions
(from sponsor)		 Obesity, Diabetes Mellitus, Type 2
Related terms Diabetes Mellitus, Type 2, Metabolic Syndrome, Obesity, Overweight, Weight Loss
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov