Effects of Tirzepatide on Skeletal Muscle in Obesity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Body Mass and Composition
研究概览
简要总结
This study is evaluating whether a dual glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist, tirzepatide, can affect the function, structure and metabolism of skeletal muscles in adults with obesity. Participants, premenopausal females with obesity, will receive either tirzepatide or placebo over 24 weeks. Researchers will assess body weight, body composition, muscle strength and functional performance, neuromuscular function and will perform muscle biopsies before and after treatment to study molecular and histological changes following treatment. The goal of this study is to investigate the effects of tirzepatide on skeletal muscle function, quantity, quality and metabolism in adults with obesity as well as clarify the molecular and structural adaptations in skeletal muscle during tirzepatide-induced weight loss, addressing an important gap in understanding the impact of incretin-based therapies on muscle health.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 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
- •Stable body weight within the three months preceding study enrolment (defined as ≤ 5% change)
- •No prior pharmacological or surgical interventions for obesity treatment
- •Commitment to use barrier contraception and absence of plans for pregnancy within 8 months following enrolment
排除标准
- •Sarcopenic obesity
- •Pregnancy or lactation
- •Postmenopausal status
- •Immobility
- •Personal history of malignancy
- •Personal history of pancreatitis
- •Personal history of major depressive episodes
- •Personal history of myopathy
- •Personal or family history of medullary thyroid carcinoma
- •Current treatment with metformin or systemic corticosteroids
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 Body Mass and Composition
时间窗: Baseline to Week 24
Measured primarily as changes in body weight and body composition measured by dual-energy X-ray absorptiometry (DXA).
Change in Quadriceps Muscle Strength
时间窗: Baseline to Week 24
Change in maximal knee extensor torque normalized to body mass (Nm/kg) will be evaluated using an isokinetic dynamometer.
次要结局
- Change in MRI-derived Skeletal Muscle Composition and Myosteatosis(Baseline to Week 24)
- Change in Molecular Markers in Vastus Lateralis Muscle: Gene-level Differential Expression(Baseline to Week 24)
- Change in Molecular Markers in Vastus Lateralis Muscle: Pathway-level Enrichment Analysis(Baseline to Week 24)
- Change in Intramyocellular Lipid Content (IMCL) in Vastus Lateralis Muscle(Baseline to Week 24)
- Change in the Muscle Fiber Diameter of Type I and Type II Fibers(Baseline to Week 24)