Effectiveness and Safety of Tirzepatide Among Participants With Obesity With or Without Type 2 Diabetes Mellitus (T2DM)

NCT07099742 | Not Yet Recruiting

• 1 other identifier: Bex-2502004
• Study Type: observational
• Target: 364
• Locations: 1 country
• Sites: 3

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.

Conditions

Obesity

Keywords

Tirzepatide; Obesity; T2DM

Outcome Measures

Primary Outcomes (2)

• 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• Percentage of participants withdrawn from the study due to adverse events by Week 24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

Secondary Outcomes (9)

• Absolute change in body weight at Week 24 across both treatment groups

  Baseline to 24 weeks

• Change from baseline in Body Mass Index (BMI) and waist circumference at Week 24 across both treatment groups

  Baseline to Week 24

• Percentage of participants achieving ≥15% reduction in body weight from baseline to Week 24

  Baseline to Week 24

• Percent change from baseline in Hemoglobin A1c (HbA1c) at Week 24

  Baseline to Week 24

• Percentage of diabetic participants achieving HbA1c <7% at Week 24

  Week 24

Study Arms (2)

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.

Drug: Tirzepatide

Lifestyle Modification Group

Participants in this group will receive standard counselling on lifestyle modifications, including diet and physical activity, as per routine clinical care.

Behavioral: Life Style Modification

Interventions

Tirzepatide DRUG

Exposure

Tirzepatide Group

Life Style Modification BEHAVIORAL

Referent group - Lifestyle interventions, exercise, and diet control

Lifestyle Modification Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Md. Alimur Reza: lead

Study Sites (3)

Trauma Centre, Cumilla.

Comilla, Bangladesh

Location

Dhaka Medical College Hospital, Dhaka

Dhaka, Bangladesh

Location

Rajshahi Medical College Hospital, Rajshahi

Rajshahi, Bangladesh

Location

Related Publications (4)

• Sustaining security's effectiveness as a hospital continues to expand. Hosp Secur Saf Manage. 1996 Sep;17(5):1-3. No abstract available.

  PMID: 10161731 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.

  PMID: 36498958 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.

  PMID: 37840095 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.

  PMID: 35658024 BACKGROUND

Related Links

• 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/

MeSH Terms

Conditions

Obesity

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Prof. Dr. Indrajit Prasad, MBBS, MD(Endo)

  Dhaka Medical College Hospital, Dhaka

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Epidemiologist

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 1, 2025
• Study Start: September 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (3)