A Study of Real-World Effectiveness and Safety of Tirzepatide Among Participants With Obesity With or Without Type 2 Diabetes Mellitus (T2DM) in Bangladesh
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 364
- 试验地点
- 3
- 主要终点
- Percentage change in body weight at Week 24 in both treatment groups.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Tirzepatide (Drug)
Lifestyle Modification Group
Participants in this group will receive standard counselling on lifestyle modifications, including diet and physical activity, as per routine clinical care.
干预措施: Life Style Modification (Behavioral)
结局指标
主要结局
Percentage change in body weight at Week 24 in both treatment groups.
时间窗: 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..
Percentage of participants withdrawn from the study due to adverse events by Week 24
时间窗: 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.
次要结局
- Absolute change in body weight at Week 24 across both treatment groups(Baseline to 24 weeks)
- Change from baseline in Body Mass Index (BMI) and waist circumference at Week 24 across both treatment groups(Baseline to Week 24)
- Percentage of participants achieving ≥15% reduction in body weight from baseline to Week 24(Baseline to Week 24)
- Percent change from baseline in Hemoglobin A1c (HbA1c) at Week 24(Baseline to Week 24)
- Percentage of diabetic participants achieving HbA1c <7% at Week 24(Week 24)
- Percentage of participants achieving the highest dose of Tirzepatide by Week 24(Up to Week 24)
- Frequency of adverse events (AEs) and serious adverse events (SAEs) reported by Week 24(Up to Week 24)
- Number of hypoglycemic events reported by Week 24(Up to Week 24)
- Number of self-reported gastrointestinal (GI) adverse events by Week 24(Up to Week 24)
研究者
Dr. Md. Alimur Reza
Study Epidemiologist
Beximco Pharmaceuticals Ltd.