Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT07099742

Opening soonNot applicableObservational

What this study is 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity

Full registry 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.

Treatments and study arms

Tirzepatide

Drug

Exposure

Life Style Modification

Behavioral

Referent group - Lifestyle interventions, exercise, and diet control

Primary outcomes

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 24Up 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.