Efficacy and Safety of Tirzepatide for Weight Management

Sponsor
Chittagong Medical College
Study ID
NCT06918405
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Obesity and Obesity-related Medical Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 1, 2025
Status verified
Apr 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
440 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tirzepatide arm
    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 Measure

Change in body weight (kg) [ Time Frame: 52 weeks ]

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