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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirzepatide Group | Participants in this group will receive subcutaneous Tirzepatide administered once weekly at a dose determined by standard clinical practice. The dose may be titrated based on patient tolerability and glycemic response. |
| |
| Lifestyle Modification Group | Participants in this group will receive standard counselling on lifestyle modifications, including diet and physical activity, as per routine clinical care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Exposure |
| |
| Life Style Modification |
| Measure | Description | Time Frame |
|---|---|---|
| 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.. | Baseline to 24 Weeks |
| Percentage of participants withdrawn from the study due to adverse events by Week 24 | The proportion of participants in each treatment group (Tirzepatide vs. lifestyle intervention) who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. | Up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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.. | Baseline to 24 weeks |
| Change from baseline in Body Mass Index (BMI) and waist circumference at Week 24 across both treatment groups |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Indrajit Prasad, MBBS, MD(Endo) | Contact | +8801729094980 | drindrajit1976@yahoo.com | |
| Prof. Dr. A.H.M Akhtaruzzaman, MBBS, MCPS, MD(Endo) | Contact | akter1974@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Prof. Dr. Indrajit Prasad, MBBS, MD(Endo) | Dhaka Medical College Hospital, Dhaka | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trauma Centre, Cumilla. | Comilla | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37152942 | Background | Ruze R, Liu T, Zou X, Song J, Chen Y, Xu R, Yin X, Xu Q. Obesity and type 2 diabetes mellitus: connections in epidemiology, pathogenesis, and treatments. Front Endocrinol (Lausanne). 2023 Apr 21;14:1161521. doi: 10.3389/fendo.2023.1161521. eCollection 2023. | |
| 36498958 | Background | Forzano I, Varzideh F, Avvisato R, Jankauskas SS, Mone P, Santulli G. Tirzepatide: A Systematic Update. Int J Mol Sci. 2022 Nov 23;23(23):14631. doi: 10.3390/ijms232314631. |
| Label | URL |
|---|---|
| World Health Organization. Obesity and overweight. Geneva: WHO; 2024. Available from: https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight | View source |
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The individual participant data (IPD) from this study will not be shared with other researchers due to institutional and regulatory restrictions related to patient confidentiality, data protection regulations, and the absence of a pre-approved data-sharing framework. Additionally, the study is designed as a real-world investigation without predefined provisions for external IPD access. Any future sharing of data will require separate ethical approval and patient re-consent, which are not within the current study's scope.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
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| Behavioral |
Referent group - Lifestyle interventions, exercise, and diet control |
|
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. |
| Baseline to Week 24 |
| 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 | Baseline to Week 24 |
| 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. | Baseline to Week 24 |
| Percentage of diabetic participants achieving HbA1c <7% at 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. | Week 24 |
| Percentage of participants achieving the highest dose of Tirzepatide by 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. | Up to Week 24 |
| Frequency of adverse events (AEs) and serious adverse events (SAEs) reported by 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. | Up to Week 24 |
| Number of hypoglycemic events reported by 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. | Up to Week 24 |
| Number of self-reported gastrointestinal (GI) adverse events by 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. | Up to Week 24 |
| Dhaka Medical College Hospital, Dhaka | Dhaka | Bangladesh |
|
| Rajshahi Medical College Hospital, Rajshahi | Rajshahi | Bangladesh |
|
| 37840095 | Background | Wadden TA, Chao AM, Machineni S, Kushner R, Ard J, Srivastava G, Halpern B, Zhang S, Chen J, Bunck MC, Ahmad NN, Forrester T. Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. Nat Med. 2023 Nov;29(11):2909-2918. doi: 10.1038/s41591-023-02597-w. Epub 2023 Oct 15. |
| 35658024 | Background | Jastreboff AM, Aronne LJ, Ahmad NN, Wharton S, Connery L, Alves B, Kiyosue A, Zhang S, Liu B, Bunck MC, Stefanski A; SURMOUNT-1 Investigators. Tirzepatide Once Weekly for the Treatment of Obesity. N Engl J Med. 2022 Jul 21;387(3):205-216. doi: 10.1056/NEJMoa2206038. Epub 2022 Jun 4. |
| World Obesity Federation. World Obesity Day Atlases \| Obesity Atlas 2025. London: Global Obesity Observatory; 2025 \[cited 2025 Mar 4\]. Available from: https://data.worldobesity.org/publications/?cat=23 | View source |
| Global Nutrition Report. Bangladesh Nutrition Profile. Bristol: Development Initiatives; 2020. Available from: https://globalnutritionreport.org/resources/nutrition-profiles/asia/southern-asia/bangladesh/ | View source |
| World Obesity Day. Obesity and NCDs. 2025. Available from: https://www.worldobesityday.org/obesity-and-ncds | View source |
| World Health Organization. Diabetes. Geneva: WHO; 2024. Available from: https://www.who.int/news-room/fact-sheets/detail/diabetes | View source |
| International Diabetes Federation. IDF Diabetes Atlas: Bangladesh \[Internet\]. Brussels: IDF; 2024. Available from: https://diabetesatlas.org/data-by-location/country/bangladesh/ | View source |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |