A Randomized Latino Semaglutide 2.4mg Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Assessment of weight loss.
研究概览
简要总结
The purpose of this study to understand better how this anti-obesity medication works to assist individuals to lose weight and maintain weight loss. This study may lead to the development of other related medications for assisting people with the disease of obesity.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-identify as being of Hispanic/Latino ethnicity
- •Age 18-75 years old
- •Able to provide informed consent before any trial related activities
排除标准
- •Current cancer treatment
- •Diabetes, Type 1 or Type 2
- •Eating disorders
- •Medication use targeting the GPL-1 system
- •In the last 30 days, attempted to lose weight by lifestyle modification alone or with the use of anti-obesity medications resulting in more than 5 pounds of weight loss.
- •History of bariatric surgery
- •Use of obesogenic medications (including but not limited to steroids, haloperidol, clozapine, risperidone, olanzapine, amitriptyline, imipramine, paroxetine, and lithium) which cannot be substituted or stopped.
- •Pregnant or planning to become pregnant in the next 8 months
- •Genetic disorders and/or physical or mental handicaps that would limit participation in the study and/or the intensive lifestyle intervention.
- •Any contraindication to semaglutide 2.4 mg including personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome Type 2, hypersensitivity to semaglutide 2.4 mg or any product components.
- •Any known or suspected allergy to semaglutide 2.4 mg or related products
- •Previous participation in this trial, either initial screening or group randomization
研究组 & 干预措施
Intervention Group
Will receive active medication semaglutide subcutaneously, once weekly, self-injection.
Month 1 - 0.24 mg SC once weekly x 4 weeks.(IE-1) Month 2- 0.5 mg SC once weekly x 4 weeks.(IE-2) Month 3 -1 mg SC once weekly x 4 weeks.(IE-3) Month 4 - 1.7 mg SC once weekly x 4 weeks.(IE-4) Month 5 - 2.4 mg SC once weekly x 4 weeks. (IE-5) Month 6 - 2.4 mg SC continue once weekly x 8 weeks.(IE-6) Month 7 - completion visit (IE-7)
干预措施: Semaglutide 2.4mg (Drug)
Control Group
Will receive placebo, subcutaneously, once weekly, self-injection throughout study duration.
干预措施: Placebo (Drug)
结局指标
主要结局
Assessment of weight loss.
时间窗: Change between baseline and final study visit, seven months post baseline.
Assessment will be based on pounds lost between baseline and final study visit.
次要结局
- Food Addiction Assessment(Change between baseline and month four of treatment.)
研究者
Warren Peters, MD, MPH
Medical Director, Center for Health Promotion, Loma Linda University and Associate Professor, School of Medicine, Loma Linda University
Loma Linda University