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

Conditions

• Obesity & Overweight
• Obesity, Morbid
• Weight Regain

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Feb 1, 2025

Status verified

Jan 2026

Primary completion

Jan 18, 2026

Completion

Jan 18, 2026

Study Design

Enrollment

254 participants (actual)

Arms

• Arm: 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.
• Arm: 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.

Primary Outcome Measure

Percentage Total Body Weight Loss (%TBWL) [ Time Frame: From baseline (initiation of tirzepatide therapy) to 6 months of treatment ]

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