Real-World Tirzepatide Therapy in Post-Bariatric Weight Regain and Preoperative Obesity Patients (NCT07382180) | Clinical Trial Compass
CompletedNot Applicable
Real-World Tirzepatide Therapy in Post-Bariatric Weight Regain and Preoperative Obesity Patients
Italy254 participantsStarted 2025-02-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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…
What they're measuring
1
Percentage Total Body Weight Loss (%TBWL)
Timeframe: From baseline (initiation of tirzepatide therapy) to 6 months of treatment