Effect of Tirzepatide on Energy Intake and Appetite-and Reward-Related Brain Areas in Overweight/Obese Subjects: A Placebo-Controlled 6-Week Study With Functional MRI
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 3
- 主要终点
- Change From Baseline in Calorie Intake in Participants Receiving Tirzepatide or Placebo at Week 3
研究概览
简要总结
The main purpose of this study is to measure the effect of tirzepatide on food intake in participants who are overweight or very overweight. The study will also use imaging to learn more about how tirzepatide affects specific parts of the brain. The effect of tirzepatide on appetite will also be studied. The study will last up to about four months and will include up to 14 visits to the study center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Tirzepatide and placebo dosing are double-blind. Liraglutide dosing is open label.
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
- •Have stable body weight for the past 1 month prior to screening
- •Have a body mass index (BMI) between 27 to 50 kilograms per meter squared (kg/m²), inclusive at screening
- •Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff
- •Women must not be pregnant or breastfeeding
排除标准
- •Have undergone or plan to undergo gastric bypass or bariatric surgery
- •Have claustrophobia or have ferromagnetic implants that can interfere with completion of fMRI measurements
- •Have other medical conditions or medical history that make participation in the study unsafe or which may interfere in the interpretation of the results of the study
- •Unwilling to comply with smoking and alcohol restrictions during the study
- •Have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening
- •Have a diagnosis of type 2 diabetes
研究组 & 干预措施
Placebo
Participants received placebo administered into the SC tissue of the abdominal wall.
干预措施: Placebo (Drug)
Tirzepatide
Participants received tirzepatide 5 milligrams (mg) once a week (QW) for Weeks 1 through 3 followed by tirzepatide 10 mg QW for Weeks 4 through 6 into the subcutaneous (SC) tissue of the abdominal wall.
干预措施: Tirzepatide (Drug)
Liraglutide
Participants received Liraglutide with step wise dose escalation regimen starting from 0.6 mg once daily (QD) for week 1 followed by 1.2 mg QD for week 2, 1.8 mg QD for week 3, 2.4 mg QD for Week 4 followed by 3 mg QD starting in Week 5 and maintained for 10 days administered into the SC tissue of the abdominal wall.
干预措施: Liraglutide (Drug)
结局指标
主要结局
Change From Baseline in Calorie Intake in Participants Receiving Tirzepatide or Placebo at Week 3
时间窗: Baseline, Week 3
Change from baseline in calorie intake in participants receiving tirzepatide or placebo at week 3 is reported.
次要结局
- Change From Baseline in Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signals in Response to Images of Highly Palatable Food Relative to Nonfood Item During Fasting State in the 5 Brain Reward Areas(Baseline, Week 3)
- Change From Baseline in Fasting and Postprandial Overall Appetite Visual Analog Scale (VAS) Score(Baseline, Week 3)