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NCT Number: NCT07099742

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Trauma Centre, Cumilla., Comilla, Bangladesh

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tirzepatide

Drug

Exposure

Life style modification

Behavioral

Referent group - Lifestyle interventions, exercise, and diet control

Primary outcomes

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

    Time frame: Baseline to 24 Weeks

    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..

  2. Percentage of participants withdrawn from the study due to adverse events by Week 24

    Time frame: Up to 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.

Secondary outcomes

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

    Time frame: Baseline to 24 weeks

    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..

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

    Time frame: Baseline to Week 24

    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.

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

    Time frame: 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

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

    Time frame: Baseline to 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.

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

    Time frame: 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.

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

    Time frame: Up to 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.

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

    Time frame: Up to 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.

  8. Number of hypoglycemic events reported by Week 24

    Time frame: Up to 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.

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

    Time frame: Up to 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.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

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

CONTACT

[email protected]

+8801729094980

Sponsors and collaborators

Lead sponsor

Dr. Md. Alimur Reza

Industry

Registry information

Official study title

A Study of Real-World Effectiveness and Safety of Tirzepatide Among Participants With Obesity With or Without Type 2 Diabetes Mellitus (T2DM) in Bangladesh

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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