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

N/ANot Yet RecruitingNCT07099742

Dr. Md. Alimur Reza364 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

364

Conditions

Obesity

Interventions

TirzepatideDRUG

Exposure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

Trauma Centre, Cumilla.

Comilla, Bangladesh

Dhaka Medical College Hospital, Dhaka

Dhaka, Bangladesh

Rajshahi Medical College Hospital, Rajshahi

Rajshahi, Bangladesh

Outcomes

Primary Outcomes

Percentage change in body weight at Week 24 in both treatment groups.

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..

Time frame: Baseline to 24 Weeks

Percentage of participants withdrawn from the study due to adverse events by 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.

Time frame: Up to Week 24

Secondary Outcomes

Absolute change in body weight at Week 24 across both treatment groups

The absolute difference 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..

Time frame: Baseline to 24 weeks

Change from baseline in Body Mass Index (BMI) and waist circumference at Week 24 across both treatment groups

The mean change in Body Mass Index (BMI, kg/m²) and waist circumference (cm) from baseline to Week 24 will be evaluated and compared between participants receiving Tirzepatide and those undergoing structured lifestyle interventions.

Time frame: Baseline to Week 24

Percentage of participants achieving ≥15% reduction in body weight from baseline to Week 24

The proportion of participants in each treatment group (Tirzepatide vs. lifestyle intervention) who achieve a ≥15% reduction in body weight from baseline to Week 24 will be assessed and compared

Time frame: Baseline to Week 24

Percent change from baseline in Hemoglobin A1c (HbA1c) at Week 24

The mean percent change in HbA1c from baseline to Week 24 will be evaluated and compared between the Tirzepatide group and the lifestyle intervention group.

Time frame: Baseline to Week 24

Percentage of diabetic participants achieving HbA1c <7% at Week 24

Among participants with Type 2 Diabetes Mellitus, the proportion achieving an HbA1c level below 7.0% at Week 24 will be assessed and compared between both treatment arms.

Time frame: Week 24

Percentage of participants achieving the highest dose of Tirzepatide by Week 24

The proportion of participants in the Tirzepatide group who are titrated to and maintained on the highest protocol-defined dose (e.g., 7.5 mg) by Week 24 will be evaluated and reported.

Time frame: Up to Week 24

Frequency of adverse events (AEs) and serious adverse events (SAEs) reported by Week 24

The total number of AEs and SAEs reported in each treatment group will be documented and compared over the 24-week period to assess the overall safety profile.

Time frame: Up to Week 24

Number of hypoglycemic events reported by Week 24

The total number of hypoglycemic episodes, as reported by participants or identified through clinical evaluation, will be recorded and compared between both groups.

Time frame: Up to Week 24

Number of self-reported gastrointestinal (GI) adverse events by Week 24

The frequency of self-reported GI-related adverse events (e.g., nausea, vomiting, diarrhea) will be captured through participant diaries or structured interviews and compared across both treatment arms.

Time frame: Up to Week 24

Central Contacts

Prof. Dr. Indrajit Prasad, MBBS, MD(Endo)

CONTACT

+8801729094980 drindrajit1976@yahoo.com

Prof. Dr. A.H.M Akhtaruzzaman, MBBS, MCPS, MD(Endo)

CONTACT

akter1974@gmail.com