Feasibility of Semaglutide Therapy for Weight Loss in Advanced Lung Disease: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Tolerability
研究概览
简要总结
The goal of this clinical trial is to learn whether semaglutide, an FDA-approved treatment for diabetes and obesity, is feasible and tolerable in patients with advanced lung disease.
The main question[s] it aims to answer are:
- Are patients with advanced lung disease able to tolerate semaglutide therapy?
- Are we able to titrate semaglutide therapy to a target weight?
Participants will be asked to perform pulmonary function, physical function and body composition testing, as well as a blood draw before and after 12-weeks of semaglutide therapy. While on therapy, subjects will be surveyed regarding any adverse events or side effects.
详细描述
This is a small open-label pilot clinical trial of semaglutide in adults (age 18 or older, n=8) with obesity (BMI≥30 kg/m2), and chronic advanced lung disease (interstitial lung disease, sarcoidosis, chronic obstructive pulmonary disease, or pulmonary hypertension requiring supplemental oxygen on exertion). This study will evaluate medication adherence and side effects to determine semaglutide tolerability. Markers of physical function and pulmonary function will be evaluated before therapy and after 12 weeks of therapy to determine the effect of semaglutide on function. Measures of fat and muscle, will be performed before therapy and after 12 weeks of therapy to evaluate how semaglutide alters body composition in this population. Study participants will be monitored for 12 weeks while receiving semaglutide therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of one of the following lung diseases: interstitial lung disease, sarcoidosis, chronic obstructive pulmonary disease, or pulmonary hypertension
- •Age > 18
- •BMI > 30 kg/m2
- •Requires supplemental oxygen on exertion
- •Stable treatment regimen X 90 days
- •Use of disease-modifying therapy
排除标准
- •Pregnant or Breastfeeding
- •Recent weight loss
- •Recent or chronic GI complaints
- •History of gastroparesis
- •History of scleroderma
- •Hospitalized at time of evaluation
- •Use of weight loss medication in last 90 days
- •Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia (type 2)
- •Uncontrolled thyroid disease
- •History of acute/chronic pancreatitis
- •Prior suicide attempt
- •Suicidal ideation in last 90 days
- •Presence of a pacemaker or defibrillator
研究组 & 干预措施
Study Drug (semaglutide)
Semaglutide Pen Injector 1.0 mg weekly Once weekly subcutaneous injection Other Name: Wegovy
干预措施: Semaglutide Pen Injector (Drug)
结局指标
主要结局
Tolerability
时间窗: 12 weeks
The proportion of participants who either reach a target semaglutide dose of 1.0 mg/week or who achieve target weight.
次要结局
- Body composition(Baseline to 12 weeks)
- Lung function(Baseline to 12 weeks)
- Physical function(Baseline to 12 weeks)
- Markers of adiposity and insulin resistance(Baseline to 12 weeks)