Набор скоро начнётся NCT07492563

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

— Наблюдательное Obesity Type 2 Diabetes Mellitus Overweight With Comorbidities

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Tirzepatide (T.G.).
Кому может быть актуально: Состояния в реестре: Obesity, Type 2 Diabetes Mellitus, Overweight With Comorbidities. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Paraguay
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

Препарат 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

Первичные конечные точки

Incidence of Adverse Events [Срок оценки: 12 months]

Вторичные конечные точки (5)

Change in Body Weight [Срок оценки: 12 months]
Change in body mass index (BMI) [Срок оценки: 12 months]
Change in systolic and diastolic blood pressure [Срок оценки: 12 months]
Change in total cholesterol, HDL cholesterol, tryglicerides [Срок оценки: 12 months]
Reasons for treatment discontinuation [Срок оценки: 12 months]

Критерии участия

Критерии включения

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