Trial · Observational
Not yet recruitingPhase not statedRegistry dataBangladesh
1 trial · 1 not yet recruiting
Effectiveness and Safety of Tirzepatide Among Participants With Obesity With or Without Type 2 Diabetes Mellitus (T2DM)
NCT07099742est. Nov 2026 to est. Dec 2027
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Other
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.
Other
Lifestyle Modification Group
Participants in this group will receive standard counselling on lifestyle modifications, including diet and physical activity, as per routine clinical care.
Outcomes the sponsor listed as primary.
Percentage change in body weight at Week 24 in both treatment groups.
Time frame · Baseline to 24 Weeks
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..
Percentage of participants withdrawn from the study due to adverse events by Week 24
Time frame · Up to 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.
Absolute change in body weight at Week 24 across both treatment groups
Time frame · Baseline to 24 weeks
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..
Change from baseline in Body Mass Index (BMI) and waist circumference at Week 24 across both treatment groups
Time frame · Baseline to Week 24
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.
Percentage of participants achieving ≥15% reduction in body weight from baseline to Week 24
Time frame · 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
Percent change from baseline in Hemoglobin A1c (HbA1c) at Week 24
Time frame · Baseline to 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.
Percentage of diabetic participants achieving HbA1c <7% at Week 24
Time frame · 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.
Percentage of participants achieving the highest dose of Tirzepatide by Week 24
Time frame · Up to 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.
Frequency of adverse events (AEs) and serious adverse events (SAEs) reported by Week 24
Time frame · Up to 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.
Number of hypoglycemic events reported by Week 24
Time frame · Up to 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.
Number of self-reported gastrointestinal (GI) adverse events by Week 24
Time frame · Up to 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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
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Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 2022
Jastreboff et al. 2022The New England journal of medicinecited by 2,802
PMID 35658024DOI 10.1056/nejmoa2206038PUB-35658024
2 studies on this page
Indexing hint: Randomized controlled trial · 2023
Wadden et al. 2023Nature medicinecited by 364
PMID 37840095PMC10667099DOI 10.1038/s41591-023-02597-wPUB-37840095
Indexing hint: Review · 2022
Forzano et al. 2022International journal of molecular sciencescited by 87
PMID 36498958PMC9741068DOI 10.3390/ijms232314631PUB-36498958
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