Obesity & OverweightTIR-REALNCT07382180
Real-World Tirzepatide Therapy in Post-Bariatric Weight Regain and Preoperative Obesity Patients
An observational study of Obesity & Overweight and Weight Regain, run by Azienda Sanitaria Locale Napoli 2 Nord at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity & Overweight, Weight Regain, Obesity, Morbid
- What is being tested?
- 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
- How many people
- 254 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2025to 18 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients with obesity managed within established bariatric and metabolic care pathways at participating referral centers. Participants are selected from individuals who initiate tirzepatide therapy as part of routine clinical practice, either for medical optimization prior to planned bariatric surgery or for the management of clinically significant weight regain following prior sleeve gastrectomy. All participants receive standard multidisciplinary care, including medical, nutritional, and metabolic evaluation, and are followed longitudinally through scheduled outpatient visits. The study population reflects a real-world clinical setting and includes patients with a broad range of obesity-related metabolic profiles, representative of routine bariatric practice.
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: More Than Weight Loss: Real-World Tirzepatide Use in Post-Bariatric Weight Regain and Preoperative Obesity Care
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.
Read the 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
- Being tested
- 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
- Keywords
- Obesity, Weight Regain, Obesity, Morbid
- Medical subject headings
- Obesity, Overweight, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 physicianDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Post-Bariatric Weight Regain | Adult patients with a history of sleeve gastrectomy who developed clinically significant weight regain, defined as an increase of at least 25% from the postoperative nadir weight, and who were treated with tirzepatide as part of routine clinical care. Receives: 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 | |
| Preoperative Obesity Management | Adult patients with obesity receiving tirzepatide as part of preoperative medical optimization before planned bariatric or metabolic surgery, managed according to standard clinical practice. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Total Body Weight Loss (%TBWL)
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.
Measured: From baseline (initiation of tirzepatide therapy) to 6 months of treatment
Secondary outcomes (3)
Change in Body Mass Index (BMI)
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.
Measured: From baseline (initiation of tirzepatide therapy) to 6 months of treatment
Safety and Tolerability of Tirzepatide
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.
Measured: From baseline (initiation of tirzepatide therapy) to 6 months of treatment
Change in Mood Status
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.
Measured: From baseline (initiation of tirzepatide therapy) to 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Feb 2025
- Primary completion18 Jan 2026
- Study completion18 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale Napoli 2 Nord
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Pizza, Azienda Sanitaria Locale Napoli 2 Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382180
- Sponsor's protocol ID
- 11182022
- Acronym
- TIR-REAL
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This is an observational real-world study based on data collected during routine clinical care. Individual participant data are derived from medical records and are subject to data protection and privacy regulations. No formal plan for sharing individual participant data has been established, as data analyses are conducted on de-identified, aggregated datasets to ensure confidentiality and regulatory compliance.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- More Than Weight Loss: Real-World Tirzepatide Use in Post-Bariatric Weight Regain and Preoperative Obesity Care
- ClinicalTrials.gov ID
- NCT07382180
- Acronym / sponsor ID
- TIR-REAL / 11182022
- Conditions
- Obesity & Overweight, Weight Regain, Obesity, Morbid
- Keywords
- Obesity, Weight Regain, Obesity, Morbid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Azienda Sanitaria Locale Napoli 2 NordUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 18 Jan 2026 (actual)
- Study completion
- 18 Jan 2026 (actual)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-Bariatric Weight Regain | – | 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 physicianAdult patients with a history of sleeve gastrectomy who developed clinically significant weight regain, defined as an increase of at least 25% from the postoperative nadir weight, and who were treated with tirzepatide as part of routine clinical care. |
| Preoperative Obesity Management | – | 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 physicianAdult patients with obesity receiving tirzepatide as part of preoperative medical optimization before planned bariatric or metabolic surgery, managed according to standard clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients with obesity managed within established bariatric and metabolic care pathways at participating referral centers. Participants are selected from individuals who initiate tirzepatide therapy as part of routine clinical practice, either for medical optimization prior to planned bariatric surgery or for the management of clinically significant weight regain following prior sleeve gastrectomy. All participants receive standard multidisciplinary care, including medical, nutritional, and metabolic evaluation, and are followed longitudinally through scheduled outpatient visits. The study population reflects a real-world clinical setting and includes patients with a broad range of obesity-related metabolic profiles, representative of routine bariatric practice.
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 physicianThis 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. | Drug | Post-Bariatric Weight Regain, Preoperative Obesity Management |
Primary outcome
Percentage Total Body Weight Loss (%TBWL)
Time frame: 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.
3 secondary outcomes
Change in Body Mass Index (BMI)
Time frame: From baseline (initiation of tirzepatide therapy) to 6 months of treatment
Safety and Tolerability of Tirzepatide
Time frame: From baseline (initiation of tirzepatide therapy) to 6 months of treatment
Change in Mood Status
Time frame: From baseline (initiation of tirzepatide therapy) to 6 months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No. This is an observational real-world study based on data collected during routine clinical care. Individual participant data are derived from medical records and are subject to data protection and privacy regulations. No formal plan for sharing individual participant data has been established, as data analyses are conducted on de-identified, aggregated datasets to ensure confidentiality and regulatory compliance.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity & Overweight and Weight Regain, run by Azienda Sanitaria Locale Napoli 2 Nord at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Total Body Weight Loss (%TBWL) (time frame: From baseline (initiation of tirzepatide therapy) to 6 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.