Safety and Effectiveness of Tirzepatide in Patients With Obesity at Hospital de Clínicas, Paraguay
NCT07492563 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300
Last updated 2026-03-25
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.
Conditions
- Obesity
- Type 2 Diabetes Mellitus
- Overweight With Comorbidities
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
Sponsors & Collaborators
-
LABORATORIOS INDUFAR
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-31
- Primary Completion
- 2026-10-31
- Completion
- 2027-10-31
Countries
- Paraguay
Study Locations
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