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

ConditionObesity
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDr. Md. Alimur Reza

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Tirzepatide
  • Life Style Modification

Treatment groups

364 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Dr. Md. Alimur Reza

Lead sponsor

Beximco Pharmaceuticals Ltd.

Sponsor institution