An observational study in Obesity, sponsored by Dr. Md. Alimur Reza. Not yet recruiting at 3 sites in Bangladesh. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Dr. Md. Alimur Reza · Observational
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 364 is above the median of 135 across 1,283 observational studies indexed under Obesity.
Browse Obesity studies →Dr. Md. Alimur Reza is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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
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
Exposure
Referent group - Lifestyle interventions, exercise, and diet control
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..
Time frame: 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.
Time frame: Up to Week 24
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..
Time frame: Baseline to 24 weeks
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Week 24
Plan to share: 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Dr. Md. Alimur Reza