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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage Total Body Weight Loss (%TBWL)
Timeframe: From baseline (initiation of tirzepatide therapy) to 6 months of treatment