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ObesityNCT07099742

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

An observational study of Obesity, run by Dr. Md. Alimur Reza at 3 sites in Bangladesh.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity
What is being tested?
Tirzepatide and Life Style Modification
How many people
364 participants
Where
3 sitesBangladesh
Study dates
Nov 2026to Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

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

Bangladesh3 sites

  • Trauma Centre, Cumilla.

    Comilla

    Prof. Dr. Ajit Kumar Paul, MBBS, MD(Endo), +8801713409655, ajitendo@gmail.com

    Prof. Dr. Ajit Kumar Paul

  • Dhaka Medical College Hospital, Dhaka

    Dhaka

    Prof. Dr. Indrajit Prasad, +8801729094980, drindrajit1976@yahoo.com

    Dr. M Saifuddin, MBBS, MD(Endo), saifk56dmc@yahoo.com

  • Rajshahi Medical College Hospital, Rajshahi

    Rajshahi

    Prof. Dr. A.H.M Akhtaruzzaman, MBBS, MCPS, MD(Endo), +8801748389609, akter1974@gmail.com

    Dr. Masud Un Nabi, MBBS, MD(Endo), masudnabi@gmail.com

Other trials in Bangladesh

About this study

Official title: A Study of Real-World Effectiveness and Safety of Tirzepatide Among Participants With Obesity With or Without Type 2 Diabetes Mellitus (T2DM) in Bangladesh

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
Being tested
Tirzepatide, Life Style Modification
Keywords
Tirzepatide, Obesity, T2DM
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TirzepatideDrug

    Exposure

  • Life Style ModificationBehavioural

    Referent group - Lifestyle interventions, exercise, and diet control

Study groups in NCT07099742
Study groupRoleWhat they receive
Tirzepatide GroupParticipants 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.
Receives: Drug: Tirzepatide
Lifestyle Modification GroupParticipants in this group will receive standard counselling on lifestyle modifications, including diet and physical activity, as per routine clinical care.
Receives: Behavioral: Life Style Modification

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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..

    Measured: Baseline to 24 Weeks

  2. 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.

    Measured: Up to Week 24

Secondary outcomes (9)

  1. 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..

    Measured: Baseline to 24 weeks

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

    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.

    Measured: Baseline to Week 24

  3. 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

    Measured: Baseline to Week 24

  4. 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.

    Measured: Baseline to Week 24

  5. 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.

    Measured: Week 24

  6. 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.

    Measured: Up to Week 24

  7. 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.

    Measured: Up to Week 24

  8. 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.

    Measured: Up to Week 24

  9. 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.

    Measured: Up to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2025
  2. Study startNov 2026 (estimated)
  3. Primary completionOct 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
364 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07099742
Sponsor's protocol ID
Bex-2502004
Status last verified
Oct 2026
First submitted
25 Jul 2025
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 37152942

  • 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.

    PubMed 36498958

  • 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.

    PubMed 37840095

  • 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.

    PubMed 35658024

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by Dr. Md. Alimur Reza at 3 sites in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Prof. Dr. Indrajit Prasad, MBBS, MD(Endo) (+8801729094980, drindrajit1976@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage change in body weight at Week 24 in both treatment groups. (time frame: Baseline to 24 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07099742, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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