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

ClinicalTrials.gov ID

NCT07099742

Lead Sponsor

Dr. Md. Alimur RezaINDUSTRY

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

364Estimated

Last Update Posted

Aug 3, 2025Actual

Start Date

Sep 2025Estimated

Primary Completion Date

Apr 2026Estimated

Completion Date

Jul 2026Estimated

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

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.

• Obesity

• Tirzepatide
• Life Style Modification

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Dr. Md. Alimur RezaINDUSTRY

drindrajit1976@yahoo.com+8801729094980

akter1974@gmail.com+8801748389609

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