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

NCT07382180 | Completed DMC FDA Drug

• 1 other identifier: 11182022
• Study Type: observational
• Target: 254
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity & Overweight; Weight Regain; Obesity, Morbid

Keywords

Obesity; Weight Regain; Obesity, Morbid

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline (initiation of tirzepatide therapy) to 6 months of treatment

Secondary Outcomes (3)

• Change in Body Mass Index (BMI)

  From baseline (initiation of tirzepatide therapy) to 6 months of treatment

• Safety and Tolerability of Tirzepatide

  From baseline (initiation of tirzepatide therapy) to 6 months of treatment

• Change in Mood Status

  From baseline (initiation of tirzepatide therapy) to 6 months of treatment

Study Arms (2)

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.

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.

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

Interventions

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 DRUG

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.

Post-Bariatric Weight Regain; Preoperative Obesity Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Sanitaria Locale Napoli 2 Nord: lead

Study Sites (1)

Head of bariatric surgery

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Obesity; Overweight; Obesity, Morbid

Interventions

Obesity Management

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Weight Reduction Programs; Health Promotion; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Disease Management; Patient Care Management; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: surgeon

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 2, 2026
• Study Start: February 1, 2025
• Primary Completion: January 18, 2026
• Study Completion: January 18, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)