Obesity, Morbid, Obesity & Overweight, Weight Regain
Conditions
Keywords
Obesity, Weight Regain, Obesity, Morbid
Brief summary
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.
Detailed description
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.
Interventions
This study is conducted as a non-interventional, investigator-initiated observational study using data collected during routine clinical practice. No randomization, blinding, or protocol-mandated procedures are applied. Treatment decisions, follow-up schedules, and clinical assessments are determined solely by the treating physicians according to standard care. Data are collected retrospectively and prospectively from clinical records and routine follow-up visits. The study does not alter patient management and does not involve additional risks beyond usual clinical practice.
Sponsors
Azienda Sanitaria Locale Napoli 2 Nord
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Total Body Weight Loss (%TBWL) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index (BMI) | From baseline (initiation of tirzepatide therapy) to 6 months of treatment | Change in body mass index (BMI) from baseline to 6 months after initiation of tirzepatide therapy. BMI was calculated as body weight in kilograms divided by height in meters squared (kg/m²). Baseline BMI was defined as the value recorded at treatment initiation. Body weight and height were measured during outpatient visits using calibrated clinical equipment. |
| Safety and Tolerability of Tirzepatide | From baseline (initiation of tirzepatide therapy) to 6 months of treatment | Incidence and type of treatment-emergent adverse events during tirzepatide therapy, including gastrointestinal symptoms and treatment discontinuation due to adverse effects. Adverse events were collected through clinical visits and review of medical records and were classified according to routine clinical practice. |
| Change in Mood Status | From baseline (initiation of tirzepatide therapy) to 6 months of treatment | Change from baseline to 6 months in self-reported mood status, assessed during routine outpatient visits using the Patient Global Mood Assessment (PGMA), a standardized, non-diagnostic patient-reported outcome measure evaluating overall mood and emotional well-being. The Patient Global Mood Assessment (PGMA) is scored on a 7-point Likert scale, ranging from -3 (marked worsening of mood) to +3 (marked improvement of mood), with 0 indicating no change compared with baseline. Higher scores indicate improvement in mood and emotional well-being, while lower scores indicate worsening. |
Countries
Italy
Outcome results
None listed