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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Incidence of Adverse Events
时间窗: 12 months
Frequency, type, severity, causality, and outcome of adverse events Special focus on serious adverse events and events of special interest.
次要结局
- Change in Body Weight(12 months)
- Change in body mass index (BMI)(12 months)
- Change in systolic and diastolic blood pressure(12 months)
- Change in total cholesterol, HDL cholesterol, tryglicerides(12 months)
- Reasons for treatment discontinuation(12 months)
研究者
Ana Iris Ramirez
Msc
Universidad Nacional de Asunción