Obesity
Conditions
Keywords
Tirzepatide, Obesity, T2DM
Brief summary
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.
Interventions
DRUGTirzepatide
Exposure
BEHAVIORALLife Style Modification
Referent group - Lifestyle interventions, exercise, and diet control
Sponsors
Dr. Md. Alimur Reza
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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). * History or presence of malignancy. * Active gallbladder disease. * Female participants who are pregnant, breastfeeding, planning pregnancy, or of childbearing potential, not using adequate contraceptive methods. * Prior or planned surgical treatment for obesity. * Use of weight-loss products (including prescription medications, over-the-counter drugs, or herbal preparations) within 3 months prior to screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change in body weight at Week 24 in both treatment groups. | Baseline to 24 Weeks | 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 | Up to 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants achieving ≥15% reduction in body weight from baseline to Week 24 | 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 | Baseline to 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. |
| Percentage of diabetic participants achieving HbA1c <7% at Week 24 | Week 24 | Among participants with Type 2 Diabetes Mellitus, the proportion achieving an HbA1c level below 7.0% at Week 24 will be assessed and compared between both treatment arms. |
| Absolute change in body weight at Week 24 across both treatment groups | Baseline to 24 weeks | 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.. |
| Frequency of adverse events (AEs) and serious adverse events (SAEs) reported by Week 24 | Up to Week 24 | The total number of AEs and SAEs reported in each treatment group will be documented and compared over the 24-week period to assess the overall safety profile. |
| Number of hypoglycemic events reported by Week 24 | Up to Week 24 | The total number of hypoglycemic episodes, as reported by participants or identified through clinical evaluation, will be recorded and compared between both groups. |
| Number of self-reported gastrointestinal (GI) adverse events by Week 24 | Up to Week 24 | The frequency of self-reported GI-related adverse events (e.g., nausea, vomiting, diarrhea) will be captured through participant diaries or structured interviews and compared across both treatment arms. |
| Percentage of participants achieving the highest dose of Tirzepatide by Week 24 | Up to Week 24 | The proportion of participants in the Tirzepatide group who are titrated to and maintained on the highest protocol-defined dose (e.g., 7.5 mg) by Week 24 will be evaluated and reported. |
| Change from baseline in Body Mass Index (BMI) and waist circumference at Week 24 across both treatment groups | Baseline to Week 24 | 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. |
Countries
Bangladesh
Contacts
Primary ContactProf. Dr. Indrajit Prasad, MBBS, MD(Endo)
Backup ContactProf. Dr. A.H.M Akhtaruzzaman, MBBS, MCPS, MD(Endo)
Outcome results
None listed