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

Not yet recruiting

• Conditions: Obesity
• Interventions: Drug: Tirzepatide; Behavioral: Life Style Modification

• Registration Number: NCT07099742
• Lead Sponsor: Dr. Md. Alimur Reza

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-25
• Study First Submitted QC: 2025-07-25
• Last Update Submitted: 2025-07-31
• Study First Posted: 2025-08-01
• Last Update Posted: 2025-08-03
• Study Start: 2025-09-01
• Primary Completion: 2026-04
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 364

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tirzepatide Group	Tirzepatide	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.
Lifestyle Modification Group	Life Style Modification	Participants in this group will receive standard counselling on lifestyle modifications, including diet and physical activity, as per routine clinical care.

Primary Outcome Measures

Name	Time	Method
Percentage change in body weight at Week 24 in both treatment groups.	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	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.

Secondary Outcome Measures

Name	Time	Method
Absolute change in body weight at Week 24 across both treatment groups	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	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	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	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	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	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	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	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	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.

Trial Locations

Locations (3)

Trauma Centre, Cumilla.; 🇧🇩 Comilla, Bangladesh

Dhaka Medical College Hospital, Dhaka; 🇧🇩 Dhaka, Bangladesh

Rajshahi Medical College Hospital, Rajshahi; 🇧🇩 Rājshāhi, Bangladesh