Effectiveness and Safety of Tirzepatide Among Participants With Obesity With or Without Type 2 Diabetes Mellitus (T2DM)
NCT ID: NCT07099742
Last Updated: 2025-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
364 participants
OBSERVATIONAL
2025-09-30
2026-07-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Tirzepatide
Exposure
Lifestyle Modification Group
Participants in this group will receive standard counselling on lifestyle modifications, including diet and physical activity, as per routine clinical care.
Life Style Modification
Referent group - Lifestyle interventions, exercise, and diet control
Interventions
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Tirzepatide
Exposure
Life Style Modification
Referent group - Lifestyle interventions, exercise, and diet control
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Dr. Md. Alimur Reza
INDUSTRY
Responsible Party
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Dr. Md. Alimur Reza
Study Epidemiologist
Principal Investigators
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Prof. Dr. Indrajit Prasad, MBBS, MD(Endo)
Role: PRINCIPAL_INVESTIGATOR
Dhaka Medical College Hospital, Dhaka
Locations
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Trauma Centre, Cumilla.
Comilla, , Bangladesh
Dhaka Medical College Hospital, Dhaka
Dhaka, , Bangladesh
Rajshahi Medical College Hospital, Rajshahi
Rajshahi, , Bangladesh
Countries
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Central Contacts
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Facility Contacts
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References
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Sustaining security's effectiveness as a hospital continues to expand. Hosp Secur Saf Manage. 1996 Sep;17(5):1-3. No abstract available.
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.
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.
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.
Related Links
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World Health Organization. Obesity and overweight. Geneva: WHO; 2024. Available from: https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight
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
Global Nutrition Report. Bangladesh Nutrition Profile. Bristol: Development Initiatives; 2020. Available from: https://globalnutritionreport.org/resources/nutrition-profiles/asia/southern-asia/bangladesh/
World Obesity Day. Obesity and NCDs. 2025. Available from: https://www.worldobesityday.org/obesity-and-ncds
World Health Organization. Diabetes. Geneva: WHO; 2024. Available from: https://www.who.int/news-room/fact-sheets/detail/diabetes
International Diabetes Federation. IDF Diabetes Atlas: Bangladesh \[Internet\]. Brussels: IDF; 2024. Available from: https://diabetesatlas.org/data-by-location/country/bangladesh/
Other Identifiers
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Bex-2502004
Identifier Type: -
Identifier Source: org_study_id
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