This is a prospective, multicenter, real-world study conducted in Bangladesh to assess the effectiveness and safety of Tirzepatide compared to structured lifestyle interventions, including dietary modifications and exercise, in obese adults with or without Type 2 Diabetes Mellitus (T2DM).
The study aims to determine whether treatment with Tirzepatide results in superior weight reduction outcomes compared to lifestyle-based approaches. Adult participants (≥18 years) with a body mass index (BMI) ≥25 kg/m² and no prior exposure to GLP-1 receptor agonists will be enrolled at the discretion of the treating physician. Eligible participants will receive either once-weekly Tirzepatide or participate in lifestyle intervention programs aligned with standard clinical care.
Adult patients of both sexes, aged ≥18 years.
Body mass index (BMI) ≥25 kg/m².
Naïve to glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy.
Self-reported stable body weight (change ≤5 kg) over the past 3 months.
Diagnosis of diabetes other than Type 2 Diabetes Mellitus.
History of chronic or acute pancreatitis.
Presence of acute medical conditions, including acute hepatitis, myocardial infarction, stroke, heart failure, febrile illness, or acute diarrheal disease.
Evidence of significant, uncontrolled endocrine disorders (e.g., Cushing's syndrome, thyroid disorders, adrenal insufficiency, congenital adrenal hyperplasia).
The study population will include adult males and females aged 18 years and older who are clinically diagnosed with obesity, with or without Type 2 Diabetes Mellitus. Eligible participants are those who have been prescribed Tirzepatide (2.5 mg, 5 mg, or 7.5 mg) administered subcutaneously once weekly, or who are undergoing structured lifestyle interventions involving extensive exercise and dietary control. Only patients meeting all inclusion criteria and none of the exclusion criteria will be enrolled in the study.
Cohort
Prospective
Tirzepatide
DrugExposure
Life Style Modification
BehavioralReferent group - Lifestyle interventions, exercise, and diet control
Percentage change in body weight at Week 24 in both treatment groups.
The percentage change in body weight (kg) from baseline to Week 24 will be assessed and compared between participants treated with Tirzepatide and those undergoing structured lifestyle interventions..
Percentage of participants withdrawn from the study due to adverse events by Week 24
The proportion of participants in each treatment group (Tirzepatide vs. lifestyle intervention) who discontinue study participation due to adverse events (AEs) will be assessed and compared.
Absolute change in body weight at Week 24 across both treatment groups
The absolute difference in body weight (kg) from baseline to Week 24 will be assessed and compared between participants treated with Tirzepatide and those undergoing structured lifestyle interventions..
Change from baseline in Body Mass Index (BMI) and waist circumference at Week 24 across both treatment groups
The mean change in Body Mass Index (BMI, kg/m²) and waist circumference (cm) from baseline to Week 24 will be evaluated and compared between participants receiving Tirzepatide and those undergoing structured lifestyle interventions.
Percentage of participants achieving ≥15% reduction in body weight from baseline to Week 24
The proportion of participants in each treatment group (Tirzepatide vs. lifestyle intervention) who achieve a ≥15% reduction in body weight from baseline to Week 24 will be assessed and compared
Percent change from baseline in Hemoglobin A1c (HbA1c) at Week 24
The mean percent change in HbA1c from baseline to Week 24 will be evaluated and compared between the Tirzepatide group and the lifestyle intervention group.
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Dr. Md. Alimur Reza
Lead sponsor
Beximco Pharmaceuticals Ltd.
Sponsor institution
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