NCT07382180

Real-World Tirzepatide Therapy in Post-Bariatric Weight Regain and Preoperative Obesity Patients

More Than Weight Loss: Real-World Tirzepatide Use in Post-Bariatric Weight Regain and Preoperative Obesity Care

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 254 (actual)
• Sponsor: Azienda Sanitaria Locale Napoli 2 Nord · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity & Overweight
• Weight Regain
• Obesity, Morbid

Interventions

Type	Name	Description
DRUG	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	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.

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-01-18
• Completion: 2026-01-18
• First posted: 2026-02-02
• Last updated: 2026-02-03

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated drug study