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

Sponsor
Dr. Md. Alimur Reza
Study ID
NCT07099742
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Tirzepatide — DRUG
    Exposure
  • Life Style Modification — BEHAVIORAL
    Referent group - Lifestyle interventions, exercise, and diet control

Study Details

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.

Key Dates

Start date
Sep 30, 2025
Status verified
Jul 2025
Primary completion
Apr 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
364 participants (estimated)

Arms

  • Arm: Tirzepatide Group
    Participants in this group will receive subcutaneous Tirzepatide administered once weekly at a dose determined by standard clinical practice. The dose may be titrated based on patient tolerability and glycemic response.
  • Arm: Lifestyle Modification Group
    Participants in this group will receive standard counselling on lifestyle modifications, including diet and physical activity, as per routine clinical care.

Primary Outcome Measure

Percentage change in body weight at Week 24 in both treatment groups. [ Time Frame: Baseline to 24 Weeks ]

Central Contacts

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