NCT07731256尚未招募2 期
A Randomized-Controlled Trial of Semaglutide for Patients With Chronic Low Back Pain and Obesity
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- BPI-SF Pain Severity Scale
研究概览
简要总结
Low back pain is the leading cause of disability in the United States, and obesity is a major risk factor for its development. GLP-1 receptor agonists such as Semaglutide have emerged as effective weight loss agents that may also reduce chronic pain through weight reduction and other mechanisms. This randomized, double-blind, placebo-controlled trial will enroll 250 adults with chronic low back pain and obesity, randomized 1:1 to weekly Semaglutide 2.4 mg or placebo for 52 weeks. The primary outcome is change in low back pain severity, with secondary outcomes including pain-related disability and quality of life.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide informed consent before any trial-related activities
- •Age: 18-85 years
- •Chronic low back pain, defined as an average low back pain severity of at least 4/10 present on most days for 3 months or longer.
- •BMI: 30-49 kg/m2
排除标准
- •Known or suspected allergy to trial medication(s), excipients, or related products
- •Contraindications to study medication(s), worded specifically as stated in the product's Prescribing Information
- •Previous randomization in this trial
- •Pregnant, breastfeeding, or the intention of becoming pregnant or not using adequate contraceptive measures
- •Low back pain related to infection, trauma, or malignancy
- •Plans to undergo new back pain interventions within 3 months.
- •Considering or have been offered surgery to treat structural disease believed to cause their low back pain, including infection, severe degeneration adjacent to a prior fusion, mobile spondylolisthesis, severe central lumbar stenosis, coronal or sagittal deformity, or other severe structural pathology diagnosed by a board-certified spine surgeon. Ambiguous cases will be adjudicated by a board-certified spine surgeon.
- •Another source of pain that is more severe than their low back pain (e.g., headache or radiculopathy)
- •History of or plans to undergo bariatric weight loss surgery
- •History of a major abdominal or stomach surgery that might affect drug absorption
- •Decrease in body weight of > 5 kg within 3 months of screening
- •History of diabetes mellitus, with HbA1c > 7 or requiring medical treatment (i.e., insulin or other diabetes medication other than Metformin).
- •Uncontrolled hypertension, defined as a systolic blood pressure (BP) > 155 mmHg or a diastolic BP > 100 mmHg
- •Clinically significant congestive heart failure, defined as New York Heart Association Class IV, or active symptoms related to heart failure, or exacerbation requiring hospitalization within 90 days of screening.
- •Any of the following: myocardial infarction, stroke, hospitalization for unstable angina pectoris, or transient ischemic attack within 90 days of screening.
- •Other medical conditions that could impact their treatment, similar to prior published reports
- •Treatment with oral or injectable glucagon-like peptide-1 (GLP-1) receptor agonists within 3 months before screening
- •Active acute or chronic pancreatitis diagnosed within 180 days or history of unprovoked pancreatitis within the past year.
- •Stage 3 or worse chronic kidney disease (i.e., eGFR < 60).
- •Known active gallstone disease, other than disease previously treated with cholecystectomy.
- •Newly diagnosed or worsening chronic liver disease.
- •Active malignancy
- •Major neurological disease, such as multiple sclerosis or Parkinson's Disease
- •Major psychiatric disease, such as psychosis or schizophrenia, or a psychiatric disease requiring hospitalization in the preceding 12 months
- •History of a suicide attempt or any reported suicidal behavior reported within 30 days of screening.
- •Personal history of MEN2
- •Personal or family history of medullary thyroid cancer
- •Impaired sensorium due to alcohol or drug use.
结局指标
主要结局
BPI-SF Pain Severity Scale
时间窗: Baseline, up to 52 weeks
The primary endpoint will be change in low back pain severity, measured using the 0-10 BPI-SF Pain Severity Scale. This outcome will be compared in the treatment group versus placebo.
次要结局
- Insomnia Severity Index(Baseline, up to 52 weeks)
- PROMIS Sleep Disturbance(Baseline, up to 52 weeks)
- Waist Circumference(Baseline, up to 52 weeks)
- BPI-SF Pain Interference(Baseline, up to 52 weeks)
- Oswestry Disability Index (ODI)(Baseline, up to 52 weeks)
- SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS)(Baseline, up to 52 weeks)
- PROMIS Depression(Baseline, up to 52 weeks)
- Pain Catastrophizing Scale(Baseline, up to 52 weeks)
- Number of New Concomitant Back Pain Treatments(Baseline, up to 52 weeks)
- Change in Serum High-Sensitivity C-Reactive Protein (hs-CRP)(Baseline, every 6 months till 52 weeks.)
- Treatment Satisfaction Questionnaire for Medication (TSQM)(Baseline, up to 52 weeks)
- Change in serum Leptin levels(Baseline, every 6 months till 52 weeks.)
研究者
Jacob Greenberg
Assistant Professor, Neurosurgery
Washington University School of Medicine
研究点 (2)
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