Real-world study to evaluate Tirzepatide's effectiveness and safety in obese adults with or without T2DM

Obesity and Type 2 Diabetes Mellitus (T2DM) are global health crises, often co-occurring and leading to severe complications. Current lifestyle interventions, while foundational, often struggle to achieve sustained weight loss and glycemic control for many individuals. Tirzepatide, a dual GLP-1 and GIP receptor agonist, has demonstrated significant efficacy in clinical trials for both weight management and T2DM. This real-world study aims to validate these benefits in a diverse population, addressing the gap in understanding its performance outside highly controlled trial settings.

This is a prospective, multicenter, real-world cohort study conducted in Bangladesh. Adult participants (≥18 years) with a BMI ≥25 kg/m² and no prior GLP-1 RA exposure will be enrolled at the discretion of their treating physician. Eligible individuals will receive either once-weekly Tirzepatide (dose titrated per standard clinical care) or participate in structured lifestyle intervention programs, including dietary modifications and exercise. The primary endpoint is to determine whether Tirzepatide treatment results in superior weight reduction outcomes compared to lifestyle-based approaches.

This document describes the protocol for an ongoing real-world study; therefore, no specific findings, numerical results, or statistical outcomes are available yet. The primary objective is to evaluate the effectiveness of Tirzepatide in achieving superior weight reduction compared to structured lifestyle interventions. Secondary objectives, which will yield quantitative data upon study completion, include assessing safety profiles, changes in BMI, HbA1c, and other metabolic parameters in participants with obesity with or without Type 2 Diabetes Mellitus. The study is designed to provide real-world insights into the clinical utility of Tirzepatide in a Bangladeshi population, complementing controlled clinical trial data.