Clinical trial

Safety and Effectiveness of Tirzepatide in Patients With Obesity at Hospital de Clínicas, Paraguay

Opening soon · Not applicable · 1 countries · Registry ID NCT07492563

Opening soonNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity, Type 2 Diabetes Mellitus, Overweight With Comorbidities

Full registry criteria

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

Treatments and study arms

Tirzepatide (T.G.)

Drug

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 Events12 months

Frequency, type, severity, causality, and outcome of adverse events Special focus on serious adverse events and events of special interest.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Endocrinology Unit, UNA, Py🌐 Asunción, Paraguay

Open map

Ana Iris RamirezContact

Email · Call +595 981 873290