Safety and Effectiveness of Tirzepatide in Patients With Obesity at Hospital de Clínicas, Paraguay (NCT07492563) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety and Effectiveness of Tirzepatide in Patients With Obesity at Hospital de Clínicas, Paraguay
Paraguay300 participantsStarted 2026-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* Type 1 diabetes or secondary diabetes
* Known hypersensitivity to tirzepatide
* Personal or family history of medullary thyroid carcinoma or MEN 2 syndrome
* Acute pancreatitis in last 12 months or chronic pancreatitis
* Severe gastrointestinal disease
* Bariatric surgery in last 12 months
* Pregnancy or breastfeeding
* Severe renal impairment (eGFR \<30 mL/min/1.73m²)
* Severe hepatic impairment (Child-Pugh B or C)
* Unstable cardiovascular disease
* Active cancer (except non-melanoma skin cancer completely resected)
* Current use of other GLP-1 receptor agonists
* Participation in another interventional trial within 30 days
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.