Safety and Effectiveness of Tirzepatide in Patients With Obesity at Hospital de Clínicas, Paraguay
Key facts
- Where
- Asunción, ParaguaySee the site
Where in Paraguay
- Endocrinology Unit, UNA, PyAsunción, ParaguayNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- LABORATORIOS INDUFAR
- Trial code
- NCT07492563
- Record updated
- 25 March 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Age ≥18 years; BMI ≥27 kg/m² with weight-related comorbidities OR BMI ≥35 kg/m²; Clinical indication for tirzepatide per treating physician; Paraguayan citizenship or permanent residence; Residence in Asunción or Metropolitan Area or possibility to assist to regular visits; Ability to attend visits for 12 months; Ability to provide written informed consent.
Exclusion: Bariatric surgery in last 12 months; Type 1 diabetes or secondary diabetes; Known hypersensitivity to tirzepatide; Personal or family history of medullary thyroid carcinoma or MEN 2 syndrome; Severe gastrointestinal disease; Severe hepatic impairment (Child-Pugh B or C); Unstable cardiovascular disease; Active cancer (except non-melanoma skin cancer completely resected); Severe renal impairment (eGFR <30 mL/min/1.73m²); Acute pancreatitis in last 12 months or chronic pancreatitis; Pregnancy or breastfeeding; Current use of other GLP-1 receptor agonists; Participation in another interventional trial within 30 days.