About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Tirzepatide
- Life Style Modification
Treatment groups
Sponsors and collaborators
Dr. Md. Alimur Reza
Lead sponsor
Beximco Pharmaceuticals Ltd.
Sponsor institution