A Novel Precision Medicine Approach For Obesity: A Randomized, Multi-Center Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Change in Total Body Weight at 24 weeks
研究概览
简要总结
This study is being done to assess the efficacy of a saliva- based biomarker to predict response to semaglutide for the treatment of obesity.
详细描述
The purpose of this study is to test the effectiveness of semaglutide 2.4 mg SQ weekly in patients with obesity with a positive MyPhenome test for abnormal postprandial satiety compared to patients with obesity with a negative MyPhenome test for abnormal postprandial satiety.
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
- Triple (Participant, Care Provider, Investigator)
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
- 否
入选标准
- •- Obesity (BMI ≥30 kg/m2) without or with controlled chronic conditions (e.g., controlled hypertension).
排除标准
- •Weight changes greater than 3% in the previous 3 months
- •History of bariatric surgery including lap band and bariatric endoscopy
- •Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia) and Columbia Suicide Severity Rating Scale (C-SSRS). If such a dysfunction is identified by an anxiety or depression score >11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up. Any suicidal ideation of type 4 or 5, any suicide attempt during the patient's lifetime, or any suicidal behavior in the last month.
- •Current use of anti-obesity medications or GLP1R agonists for Type 2 Diabetes
- •Any contraindication to FDA-approved GLP1R agonists
- •A person who is pregnant or wanting to become pregnant
- •Once the positive or negative cohort is filled at 2:1 ratio, some patients will be screen failed if their gene cohort is full.
- •A family member who is enrolled in this study.
- •Principal Investigator Discretion
研究组 & 干预措施
Placebo Group
Subjects will take placebo weekly for 24 weeks.
干预措施: Placebo (Drug)
Semaglutide Group
Subjects will take semaglutide weekly for 24 weeks
干预措施: Semaglutide (Drug)
结局指标
主要结局
Change in Total Body Weight at 24 weeks
时间窗: Baseline, 24 weeks
Percent change in body weight in biomarker positive participants vs. biomarker negative participants taking semaglutide vs placebo.
次要结局
- Percentage of Responders >5%(24 weeks)
- Percentage of Responders >10%(24 weeks)
- Percentage of Responders >15%(24 weeks)
- Percentage of Responders >20%(24 weeks)
- Change in Total Body Weight at 3 months(Baseline, 3 months)
- Change in Total Body Weight at 6 months(Baseline, 6 months)
- Change in Waist Circumference(Baseline, 24 weeks)
研究者
Andres J. Acosta, M.D., Ph.D.
Principal Investigator
Mayo Clinic