Health Trials

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

ConditionsObesityType 2 Diabetes MellitusOverweight With Comorbidities
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLABORATORIOS INDUFAR

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients who attend the Endocrinology Unit of Hospital de Clínicas, Universidad Nacional de Asunción, Paraguay

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Tirzepatide Treatment Group1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Adverse Events

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

Time frame
12 months

Secondary outcomes

1

Change in Body Weight

Description: Mean change in body weight from baseline Unit of measure: Kilograms (kg)

Time frame
12 months
2

Change in body mass index (BMI)

Description: Mean change in BMI calculated as weight(kg)/height(m)² Unit of measure: kg/m²

Time frame
12 months
3

Change in systolic and diastolic blood pressure

Description: Mean change in systolic and diastolic blood pressure measured with calibrated digital sphygmomanometer Unit of measure: mmHg

Time frame
12 months
4

Change in total cholesterol, HDL cholesterol, tryglicerides

Description: Mean change in serum total cholesterol levels using enzymatic method Unit of measure: mg/dL

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

LABORATORIOS INDUFAR

Lead sponsor

Universidad Nacional de Asunción

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: