Assessing the Role of GLP-1 Receptor Agonist Semaglutide and Dual GLP-I/GIP Receptor Agonist Tirzepatide in Delaying Genetic Aging in Adult Obese Patients Using the iWatchAge Technology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in DNA methylation-based biological age measured by iWatchAge
研究概览
简要总结
This study is a prospective, randomized, open-label clinical trial enrolling 66 adults with simple obesity who have not used weight-loss medications for at least 3 months. Participants will receive semaglutide, tirzepatide, or metformin for 24 weeks. Changes in "biological (epigenetic) age" will be assessed using the iWatchAge DNA methylation age test, while simultaneously monitoring improvements in aging-related biomarkers such as inflammatory factors, metabolic parameters, and body composition. The aim is to determine whether incretin-based therapies can reverse or slow obesity-related accelerated epigenetic aging and to provide new clinical evidence for interventions targeting obesity and aging.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 75 years.
- •Diagnosed with simple obesity, defined as BMI ≥ 30 kg/m².
- •Have not used any anti-obesity medications (including GLP-1 RAs, tirzepatide, metformin for weight loss, etc.) within the past 3 months.
- •Able and willing to comply with study procedures and complete follow-up assessments.
- •Provide written informed consent.
排除标准
- •Presence of secondary obesity (e.g., endocrine disorders such as Cushing's syndrome or hypothyroidism).
- •Use of anti-obesity medications or participation in another weight-loss program within the past 3 months.
- •Diagnosed type 1 or type 2 diabetes mellitus requiring hypoglycemic drug therapy.
- •History of pancreatitis, severe gastrointestinal disease, or bariatric surgery.
- •Severe cardiovascular, hepatic, renal, or psychiatric disease that may affect participation.
- •Pregnant or breastfeeding women, or women planning pregnancy during the study period.
- •Current participation in any other clinical trial.
- •Any condition that, in the investigator's judgment, makes the participant unsuitable for the study.
研究组 & 干预措施
Semaglutide Group
Semaglutide administered once weekly by subcutaneous iniection. Dose titrated from 0.25 mg to 2.0 mg as tolerated over 24 weeks
干预措施: Semaglutide (Drug)
Tirzepatide Group
Tirzepatide administered once weekly by subcutaneous injection. Dose titrated from 2.5 mg to 10 mg as tolerated over 24 weeks
干预措施: Tirzepatide (Drug)
Metformin Group
Metformin administered orally. Dose titrated from 500 mg to 1500-2000 mg daily, based on tolerance, for 24 weeks.
干预措施: Metformin (Drug)
结局指标
主要结局
Change in DNA methylation-based biological age measured by iWatchAge
时间窗: Baseline and Week 24
Change in epigenetic biological age from baseline to Week 24, measured using the iWatchAge DNA methylation assay. This outcome reflects whether semaglutide, tirzepatide, or metformin can delay or reverse obesity-associated accelerated epigenetic aging.
次要结局
未报告次要终点