Effectiveness and Safety of Tirzepatide (t.g.) in Patients Treated at the Obesity Unit of the Department of Endocrinology of the Hospital de Clínicas, Faculty of Medical Sciences, UNA: Phase 4 Study

Official Summary

This is a Phase 4 observational study evaluating the safety and effectiveness of tirzepatide (T.G.) manufactured by INDUFAR S.A. in 300 patients with obesity treated at the Obesity Unit of Hospital de Clínicas in Paraguay over 12 months. The primary objective is to assess the safety profile through monitoring adverse events. Secondary objectives include evaluating weight loss, metabolic parameters improvement, and treatment satisfaction in real-world clinical practice.

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 300 participants

Interventions

• DRUG: Tirzepatide (T.G.) — Subcutaneous injection once weekly Dose escalation: 2.5 mg → 5 mg → 7.5 mg → 10 mg → 12.5 mg → 15 mg Duration: 12 months

Primary Outcomes

• Incidence of Adverse Events (12 months)

Secondary Outcomes

• Change in Body Weight (12 months)
• Change in body mass index (BMI) (12 months)
• Change in systolic and diastolic blood pressure (12 months)
• Change in total cholesterol, HDL cholesterol, tryglicerides (12 months)
• Reasons for treatment discontinuation (12 months)

Trial Locations

• Endocrinology Unit, UNA, Py, Asunción, Paraguay

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