Evaluating the Efficacy of Various Weekly GLP1receptor Agonist Among Obese Individuals Without Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- change in body weight at 3 and 6 months
研究概览
简要总结
This randomized controlled trial evaluates the efficacy of three weekly GLP-1 receptor agonists (dulaglutide, semaglutide, and tirzepatide) in non-diabetic obese adults. 150 participants with BMI >30 will be randomized into three groups and followed for 6 months to assess changes in weight, BMI, lipid profile, and liver functions.
详细描述
This is a single-center, randomized controlled trial planned at Al-Zafer Hospital, Najran, KSA.
150 non-diabetic obese participants (BMI >30, age >18) will be randomized into three equal groups: Group 1: Dulaglutide 1.5 mg weekly Group 2: Semaglutide 1.0 mg weekly Group 3: Tirzepatide 5 mg weekly, titrated as tolerated
Participants will be assessed at baseline, 3 months, and 6 months for weight, BMI, waist circumference, fasting glucose, lipid profile, and liver enzymes. Monthly follow-up will ensure medication adherence and monitor gastrointestinal adverse events.
Inclusion: BMI >30, age >18, non-diabetic. Exclusion: Diabetes, liver disease, renal dysfunction, pancreatic disease, thyroid disease, psychological disorders, pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects (above 18 years old) obese body mass index (BMI) above 30
排除标准
- •Subjects with liver disease, renal dysfunction diabetes, pancreatic diseases ,thyroid disorder or goiter psychological diseases like depression and pregnant women, and Patients who will refuse
研究组 & 干预措施
Tirzepatide Group
Includes 50 non-diabetic obese participants receiving Tirzepatide 15 mg subcutaneous once weekly for 24 weeks
干预措施: Tirzepatide (Drug)
Semaglutide Group
Includes 50 non-diabetic obese participants receiving semaglutide 2.4 mg subcutaneous once weekly for 24 weeks
干预措施: Semagludtide (Drug)
Dulaglutide Group
Includes 50 non-diabetic obese participants receiving dulaglutide 1.5 mg subcutaneous once weekly for 24 weeks
干预措施: Dulaglutide (Drug)
结局指标
主要结局
change in body weight at 3 and 6 months
时间窗: Baseline, Week 12 (3 months) and Week 24 (6 months)
Change from baseline in body weight (kg) at 3 and 6 months analyzed separately among obese non-diabetic participants receiving weekly GLP-1 receptor agonists.
次要结局
- Change in Body Mass Index (BMI)(Baseline, 3 months, and 6 months)
- Change in Glycated Hemoglobin (HbA1c)(Baseline, 3 months, and 6 months)
- Change in Low-Density Lipoprotein Cholesterol (LDL-C)(Baseline, 3 months, and 6 months)
- Change in Triglycerides(Baseline, 3 months, and 6 months)
- Change in High-Density Lipoprotein Cholesterol (HDL-C)(Baseline, 3 months, and 6 months)
- Change in Total Cholesterol (TC)(Baseline, 3 months, and 6 months)
- Change in Alanine Aminotransferase (ALT)(Baseline, 3 months, and 6 months)
- Change in Aspartate Aminotransferase (AST)(Baseline, 3 months, and 6 months])
研究者
Osama Ibraheem husini Moustafa
Lecturer of Internal Medicine, Zagazig University
Zagazig University