Efficacy and Safety of Tirzepatide for Weight Management

Phase 3

Active, not recruiting

• Conditions: Obesity and Obesity-related Medical Conditions
• Interventions: Drug: Tirzepatide

• Registration Number: NCT06918405
• Lead Sponsor: Chittagong Medical College

Brief Summary

The goal of this study is to learn if tirzepatide helps people manage their weight safely. It will include adults in Bangladesh who are overweight or obese, with or without type 2 diabetes. The main questions it aims to answer are:

Does tirzepatide help people lose weight?

What side effects do people experience while taking tirzepatide?

All participants will:

Receive tirzepatide as a weekly injection, starting at 2.5 mg and gradually increasing to 15 mg.

Continue the treatment for 52 weeks (12 months).

Visit the clinic for regular checkups and tests.

Researchers will measure changes in body weight, BMI, waist size, blood sugar, blood pressure, and cholesterol levels. They will also track any side effects and assess the participants' overall health and quality of life during the study.

Detailed Description

Obesity has emerged as a critical global public health issue, significantly linked to an increased risk of various comorbidities, including type 2 diabetes mellitus (T2DM), hypertension, dyslipidemia, and cardiovascular diseases. While lifestyle modifications, such as adhering to a low-calorie diet and enhancing physical activity, remain the cornerstone of obesity management, the recent development of anti-obesity medications such as GLP-1 agonists has transformed treatment options. This study aims to evaluate the efficacy and safety of tirzepatide, GLP-1 agonist, in weight management among overweight or obese adult individuals, both with and without T2DM in Bangladesh.

This single treatment arm clinical trial will be conducted in a real-world setting, enrolling male and female adults aged 18 years or older, with a body mass index (BMI) of ≥30 kg/m² or ≥25-29.9 kg/m² if they have at least one weight-related comorbidity, such as, hypertension, or dyslipidemia. All the individuals recruited in the present study will receive subcutaneous injections of tirzepatide, initiated at a dose of 2.5 mg once weekly for the first four weeks, with incremental increases of 2.5 mg every four weeks, reaching the maintenance dose of 15 mg once weekly. The follow-up period will be 52 weeks (12 months) from the start of treatment.

The primary efficacy endpoint will be the percentage change in body weight from baseline at week 52. Secondary endpoints will include the proportion of participants achieving weight reductions of ≥5%, ≥10%, ≥15%, and ≥20% after 52 weeks, as well as changes in body weight (kg), BMI (kg/m²), waist circumference (cm), HbA1c (%), fasting plasma glucose (FPG) (mg/dL), blood pressure (both systolic and diastolic), serum lipid levels (mg/dL), modifications in hypoglycemic and antihypertensive medications, and overall quality of life assessed through an obesity-specific QoL instrument. The study will also evaluate the incidence and severity of adverse events, alongside physical examination results, blood pressure measurements, and laboratory parameter changes from baseline.

Adhering to Good Clinical Practice Guidelines, this study will follow ethical principles outlined in the Declaration of Helsinki.

Study Timeline

• Study Start: 2025-01-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-02
• Study First Submitted QC: 2025-04-02
• Last Update Submitted: 2025-04-02
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-09
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tirzepatide arm	Tirzepatide	All the included patients in both the diabetic and nondiabetic groups will receive the same intervention of tirzepatide at a dose of 15 mg administered subcutaneously once a week in addition to lifestyle modification. Initially, tirzepatide will be started with a dose of 2.5 mg once weekly subcutaneous injection for the first 4 weeks. After the stabilization period of the drug, the dose will be increased to 5 mg after 4 weeks, 7.5 mg after 8 weeks, 10 mg after 12 weeks, 12.5 mg after 16 weeks and finally 15 mg after 20 weeks.

Primary Outcome Measures

Name	Time	Method
Change in body weight (kg)	52 weeks	Change in body weight (kg) \[5%, 10%, 15% and 20%\] from baseline at week 0 to week 52

Secondary Outcome Measures

Name	Time	Method
Change in BMI	52 weeks	Change in BMI (kg/m2) from baseline at week 0 to week 52
Change in Waist circumference	52 weeks	Change in Waist circumference (cm) from baseline at week 0 to week 52
Change in HbA1c	52 weeks	Change in HbA1c (%) from baseline at week 0 to week 52
Change in fasting plasma glucose	52 weeks	Change in fasting plasma glucose (FPG) (mg/dl) from baseline at week 0 to week 52
Change in blood pressure	52 weeks	Change in systolic and diastolic blood pressure (mmHg) from baseline at week 0 to week 52
Change in lipid profile	52 weeks	Change in lipid profile (mg/dl) from baseline at week 0 to week 52 i. Total cholesterol ii. High-density lipoprotein (HDL) cholesterol iii. Low-density lipoprotein (LDL) cholesterol iv. Triglycerides
Change in serum creatinine	52 weeks	Change in serum creatinine (mg/dl) from baseline at week 0 to week 52
Dose alteration in antidiabetic drugs	52 weeks	Dose alteration (reduction or increment) or change/addition of hypoglycemic agents in patients with T2DM from baseline at week 0 to week 52
Dose alteration of antihypertensive drugs	52 weeks	Dose alteration (reduction or increment) or change/addition of antihypertensive agents in patients with hypertension from baseline at week 0 to week 52
Adverse events	52 weeks	Number of treatment-related adverse events and serious adverse events (SAEs) from baseline at week 0 to week 52
Change in quality of life	52 weeks	Patients' overall quality of life, measured by the Obesity-specific QoL instrument (OSQOL). The instrument includes four domains: physical state, vitality, social interactions, and psychological state

Trial Locations

Locations (1)

Chittagong Medical College Hospital; 🇧🇩 Chittagong, Bangladesh