Effect of Tirzepatide-Induced Weight Loss on Adipose Tissue in Obesity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change in Brown Adipose Tissue Activity and Volume
研究概览
简要总结
This study is testing whether a new anti-obesity medicine called tirzepatide can increase the activity of special fat cells in the body that help burn energy. These fat cells are known as brown and beige fat. The study includes women with obesity and will last 24 weeks.
Participants will receive either tirzepatide or a placebo (a look-alike injection with no active drug). Researchers will measure the amount and activity of brown fat using medical imaging (PET/CT, MRI, and thermal camera), and examine fat tissue samples to look for changes in gene activity and structure that show beige fat activation.
The study will also evaluate how these fat changes affect body weight, energy use, hormone levels, blood sugar, and other health markers. The goal is to learn whether tirzepatide helps improve metabolism by increasing energy-burning fat in addition to reducing appetite.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female sex
- •Age between 18 and 50 years
- •BMI between 30 kg/m² and 40 kg/m² at pre-screening
- •Prior comprehensive non-pharmacological and non-surgical management of obesity, including a history of at least 12 months of intensive lifestyle intervention with a maximum weight reduction of less than 5%
- •Stable body weight within the three months preceding study enrollment (defined as weight fluctuations within 5%)
- •No prior pharmacological or surgical interventions for obesity
- •Euthyroid state
- •Eumenorrhea or Oligomenorrhea
- •Ability to comprehend the study objectives and procedures
- •Willingness to provide informed consent and to comply with the study protocol, including the use of highly effective contraception during the study period, with signed consent and agreement provided in duplicate
- •Commitment to use highly reliable contraception and absence of plans for pregnancy within the 8 months following enrollment
排除标准
- •Pregnancy or lactation
- •Postmenopausal
- •Type 2 diabetes
- •Reliance on natural contraception methods
- •Non-compliance with previous therapeutic regimens
- •Personal history of malignancy
- •Personal or family history of medullary thyroid carcinoma
- •Personal history of pancreatitis
- •Personal history of cholelithiasis
- •Personal history of major depressive episodes or suicidal ideation
- •Personal history of acute coronary events or hemodynamically significant coronary artery disease
- •Psychiatric disorders
- •Current treatment with sympathomimetics or sympatholytics
- •Excessive alcohol consumption
研究组 & 干预措施
Tirzepatide
干预措施: Tirzepatide (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Brown Adipose Tissue Activity and Volume
时间窗: Baseline to Week 24
Assessed using 18F-FDG-PET/CT, magnetic resonance imaging (MRI), and infrared thermography. Outcome measured as change in mean standardized uptake value, supraclavicular skin temperature, and BAT volume in predefined anatomical regions (supraclavicular and cervical areas) between baseline and after 24 weeks of treatment.
Change in Molecular Markers of Browning in Subcutaneous White Adipose Tissue
时间窗: Baseline to Week 24
Measured as changes in the expression levels of uncoupling protein 1 (UCP1) and other browning-associated genes (via RT-PCR and RNA sequencing) in subcutaneous white adipose tissue (WAT) biopsies. Additionally, assessed through histomorphometric analysis of adipocyte phenotype, including the proportion of multilocular (plurivacuolar) adipocytes, immune cell infiltration, and microvascular density, to characterize tissue remodeling indicative of beige adipocyte induction.
次要结局
- Correlation Between Different BAT Assessment Methods(Baseline and Week 24)
- Change in Resting Energy Expenditure(Baseline to Week 24)
- Association Between Changes in Resting Energy Expenditure, Metabolic Health Markers, and Thermogenic Adipose Tissue(Baseline to Week 24)
- Association Between Resting Energy Expenditure, Metabolic Health Markers, and Thermogenic Adipose Tissue(Baseline)