NCT07492563Not yet recruiting
Safety and Effectiveness of Tirzepatide in Patients With Obesity at Hospital de Clínicas, Paraguay
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
Source: ClinicalTrials.gov · Last updated 25 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 12 Dec 2025
- Start date
- Mar 2026
- Primary completion date
- Oct 2026
- Lead sponsor
- LABORATORIOS INDUFAR
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT07492563
What you commit to
- Study type: Observational
- Planned participants: 300
- From Mar 2026 to the primary completion date, Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Bariatric surgery in last 12 months
Other illness
- 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)
Lab values
- Severe renal impairment (eGFR \<30 mL/min/1.73m²)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Endocrinology Unit, UNA, Py Coordinator of this site? Confirm its status | Asunción | Paraguay | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.