More Than Weight Loss: Real-World Tirzepatide Use in Post-Bariatric Weight Regain and Preoperative Obesity Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- Percentage Total Body Weight Loss (%TBWL)
研究概览
简要总结
This multicenter retrospective observational study evaluates the real-world use of tirzepatide in adult patients with post-bariatric weight regain and in patients with obesity undergoing preoperative management. The study analyzes changes in body weight and metabolic parameters, as well as treatment tolerability and safety, during routine clinical care. No experimental interventions are performed, and all patients receive tirzepatide as part of standard medical practice.
详细描述
Obesity is a chronic and progressive disease that often requires long-term management. Although bariatric surgery is an effective treatment for severe obesity, a significant proportion of patients experience weight regain several years after surgery. In addition, many patients with obesity require medical treatment before surgery to reduce surgical risk and improve perioperative outcomes. In both situations, there is a growing need for effective and well-tolerated pharmacological therapies that can be integrated into routine clinical care.
Tirzepatide is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that has demonstrated significant effects on body weight reduction and metabolic control. While its efficacy has been established in randomized clinical trials, data on its use in real-world clinical practice, particularly in post-bariatric patients with weight regain and in patients undergoing preoperative obesity management, are still limited.
This multicenter observational cohort study evaluates the real-world use of tirzepatide in adult patients managed within routine bariatric and metabolic care pathways. The study includes two patient populations: individuals with clinically significant weight regain after sleeve gastrectomy and patients with obesity treated with tirzepatide as part of preoperative medical optimization before planned surgical intervention. All patients receive tirzepatide according to standard clinical practice, without any experimental procedures or protocol-mandated treatment changes.
Clinical, anthropometric, and metabolic data are collected at baseline and during scheduled follow-up visits, in accordance with routine care. The primary objective is to assess changes in body weight over time. Secondary objectives include evaluation of metabolic parameters, treatment tolerability, and the occurrence of adverse events. Safety data are collected as part of standard clinical monitoring.
By analyzing outcomes in a real-world setting, this study aims to provide clinically meaningful evidence on the effectiveness and safety of tirzepatide outside of controlled trial environments. The results are intended to support clinicians in decision-making for the management of obesity in complex clinical scenarios, such as post-bariatric weight regain and preoperative optimization, and to better define the role of pharmacological therapy as part of an integrated, long-term obesity care strategy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •nclusion Criteria
- •Adult patients aged 18 years or older.
- •Diagnosis of obesity, defined according to standard clinical criteria, managed within a bariatric and metabolic care pathway.
- •Initiation of tirzepatide therapy at a starting dose of 5 mg as part of routine clinical practice.
- •Allocation to one of the following clinical cohorts:
- •Patients with prior sleeve gastrectomy and clinically significant weight regain, defined as a ≥25% increase in body weight relative to the postoperative nadir weight, with a minimum interval of 36 months from surgery; or
- •Patients with obesity undergoing preoperative medical optimization prior to planned bariatric surgery.
- •Availability of complete baseline clinical and anthropometric data at treatment initiation.
- •Planned clinical follow-up for at least 6 months after initiation of tirzepatide therapy.
- •Ability to provide written informed consent for the use of clinical data for research purposes, according to local regulations.
排除标准
- •Age younger than 18 years.
- •Prior bariatric procedures other than sleeve gastrectomy (for the weight regain cohort).
- •Current or previous treatment with tirzepatide before study enrollment.
- •Use of other anti-obesity pharmacological agents during the observation period.
- •Contraindications to tirzepatide therapy according to the approved product label.
- •Pregnancy or breastfeeding at the time of treatment initiation or during follow-up.
- •Presence of severe medical, psychiatric, or cognitive conditions that, in the investigator's judgment, could interfere with adherence to treatment or follow-up assessments.
- •Incomplete baseline data or anticipated inability to complete the planned 6-month follow-up.
研究组 & 干预措施
Post-Bariatric Weight Regain
Adult patients with a history of sleeve gastrectomy who developed clinically significant weight regain, defined as an increase of at least 25% from the postoperative nadir weight, and who were treated with tirzepatide as part of routine clinical care.
干预措施: Tirzepatide is administered as part of routine clinical care for obesity management, according to standard prescribing practices. Dosing and treatment duration are determined by the treating physician (Drug)
Preoperative Obesity Management
Adult patients with obesity receiving tirzepatide as part of preoperative medical optimization before planned bariatric or metabolic surgery, managed according to standard clinical practice.
干预措施: Tirzepatide is administered as part of routine clinical care for obesity management, according to standard prescribing practices. Dosing and treatment duration are determined by the treating physician (Drug)
结局指标
主要结局
Percentage Total Body Weight Loss (%TBWL)
时间窗: From baseline (initiation of tirzepatide therapy) to 6 months of treatment
Percentage total body weight loss (%TBWL) was calculated as the percentage change in body weight from baseline to 6 months after initiation of tirzepatide therapy. Baseline body weight was defined as the body weight recorded at the start of treatment. Body weight measurements were obtained during scheduled outpatient visits using calibrated clinic scales, with participants wearing light clothing and no shoes. %TBWL was calculated using the following formula: \[(baseline body weight - follow-up body weight) / baseline body weight\] × 100. This outcome measure was selected as a standardized and clinically meaningful indicator of treatment effectiveness in obesity management, allowing comparison of weight reduction across patients with different baseline body weights and clinical indications.
次要结局
- Change in Body Mass Index (BMI)(From baseline (initiation of tirzepatide therapy) to 6 months of treatment)
- Safety and Tolerability of Tirzepatide(From baseline (initiation of tirzepatide therapy) to 6 months of treatment)
- Change in Mood Status(From baseline (initiation of tirzepatide therapy) to 6 months of treatment)
研究者
Francesco Pizza
surgeon
Azienda Sanitaria Locale Napoli 2 Nord