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

Beximco

Status: Not yet enrolling

Conditions: Obesity

Treatments: Drug: Tirzepatide; Behavioral: Life Style Modification

Study type: Observational

Funder types: Industry

Identifiers

NCT07099742

Bex-2502004

Details and patient eligibility

About

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.

Enrollment: 364 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

364 participants in 2 patient groups

Tirzepatide Group

Description:

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.

Treatment:

Drug: Tirzepatide

Lifestyle Modification Group

Description:

Participants in this group will receive standard counselling on lifestyle modifications, including diet and physical activity, as per routine clinical care.

Treatment:

Behavioral: Life Style Modification