NCT07382180Completed
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
Source: ClinicalTrials.gov · Last updated 3 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 254 (actual)
- First submitted
- 26 Jan 2026
- Start date
- 1 Feb 2025
- Primary completion date
- 18 Jan 2026
- Lead sponsor
- Azienda Sanitaria Locale Napoli 2 Nord
- Diseases
- Obesity
- NCT number
- NCT07382180
What you commit to
- Study type: Observational
- Participants enrolled: 254
- From 1 Feb 2025 to the primary completion date, 18 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior bariatric procedures other than sleeve gastrectomy (for the weight regain cohort).
- Current or previous treatment with tirzepatide before study enrollment.
- Contraindications to tirzepatide therapy according to the approved product label.
Other illness
- Presence of severe medical, psychiatric, or cognitive conditions that, in the investigator's judgment, could interfere with adherence to treatment or follow-up assessments.
Age
- Age younger than 18 years.
Other
- Use of other anti-obesity pharmacological agents during the observation period.
- Pregnancy or breastfeeding at the time of treatment initiation or during follow-up.
- Incomplete baseline data or anticipated inability to complete the planned 6-month follow-up.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Head of bariatric surgery Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.