Effectiveness and Safety of Tirzepatide Among Participants With Obesity With or Without Type 2 Diabetes Mellitus (T2DM)
Launched by DR. MD. ALIMUR REZA · Jul 25, 2025
Trial Information
Current as of August 19, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how well a medication called Tirzepatide works to help adults with obesity lose weight, compared to following a structured lifestyle program that includes changes in diet and exercise. The study will include adults who have a body weight that is considered overweight or obese (with a body mass index, or BMI, of 25 or higher) and who have not used similar weight-loss medications before. Some participants may have Type 2 Diabetes, but others may not.
If you join the study, you will either receive a once-weekly injection of Tirzepatide or participate in a lifestyle program focused on healthy eating and physical activity. The researchers want to see if Tirzepatide is more effective and safe for weight loss than lifestyle changes alone. To be eligible, participants need to be adults with stable weight in recent months and not have serious medical conditions like certain cancers, pancreatitis, or uncontrolled hormonal problems. Pregnant or breastfeeding women and those planning pregnancy are not eligible. This study is being conducted in Bangladesh and is not yet open for enrolling participants.
Gender
ALL
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.
About Dr. Md. Alimur Reza
Dr. Md. Alimur Reza is a dedicated clinical trial sponsor with a robust background in medical research and a commitment to advancing healthcare through innovative studies. With extensive experience in clinical trial design and implementation, Dr. Reza focuses on delivering high-quality, evidence-based solutions that address critical health challenges. His leadership ensures compliance with regulatory standards while fostering collaboration among multidisciplinary teams. Dr. Reza is dedicated to improving patient outcomes and enhancing the overall effectiveness of therapeutic interventions through rigorous scientific inquiry and ethical research practices.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Comilla, , Bangladesh
Dhaka, , Bangladesh
Rājshāhi, , Bangladesh
Patients applied
Trial Officials
Prof. Dr. Indrajit Prasad, MBBS, MD(Endo)
Principal Investigator
Dhaka Medical College Hospital, Dhaka
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported