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Not yet recruiting NCT07492563

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

— Observational Obesity Type 2 Diabetes Mellitus Overweight With Comorbidities

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tirzepatide (T.G.).
Who it may be relevant to
Registry conditions: Obesity, Type 2 Diabetes Mellitus, Overweight With Comorbidities. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Paraguay
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

This prospective, single-center, open-label, observational Phase 4 study will enroll 300 patients with obesity (BMI ≥27 kg/m² with comorbidities or BMI ≥35 kg/m²) with or without type 2 diabetes at the Obesity Unit of Hospital de Clínicas, Asunción, Paraguay.

Patients will receive tirzepatide subcutaneously once weekly following a dose-escalation schedule: 2.5 mg (weeks 1-4), 5 mg (weeks 5-8), with optional escalation to 7.5 mg, 10 mg, 12.5 mg, or 15 mg based on tolerability and response. The medication will be provided free of cost by the sponsor INDUFAR S.A.

The study includes 4 in-person visits (baseline, months 3, 6, 12) and 2 telephone contacts (months 1, 9). Assessments include physical examination, laboratory tests (HbA1c in diabetics, fasting glucose, lipid profile, renal and hepatic function), adverse event monitoring, and quality of life questionnaires.

Primary endpoint: Incidence, type, severity, and outcome of adverse events during 12 months, with special attention to serious adverse events and events of special interest (pancreatitis, severe hypersensitivity, severe hypoglycemia, biliary disease, acute kidney injury).

Secondary endpoints: Change in body weight and BMI, proportion achieving ≥5%, ≥10%, ≥15% weight loss, change in HbA1c (in diabetics), cardiometabolic parameters, treatment adherence, and patient satisfaction.

This study will generate the first evidence on tirzepatide in the Paraguayan population and support clinical decision-making regarding use of this dual GIP/GLP-1 receptor agonist in real-world obesity management.

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

Primary outcome measures

  • Incidence of Adverse Events [Time frame: 12 months]
Secondary outcome measures (5)
  • Change in Body Weight [Time frame: 12 months]
  • Change in body mass index (BMI) [Time frame: 12 months]
  • Change in systolic and diastolic blood pressure [Time frame: 12 months]
  • Change in total cholesterol, HDL cholesterol, tryglicerides [Time frame: 12 months]
  • Reasons for treatment discontinuation [Time frame: 12 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Paraguay · 1 center
  • Endocrinology Unit, UNA, Py — Asunción

Identifiers

NCT: NCT07492563 · TG-PY-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗