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临床试验/NCT07731256
NCT07731256尚未招募2 期

A Randomized-Controlled Trial of Semaglutide for Patients With Chronic Low Back Pain and Obesity

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2027年2月1日最近更新:
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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacob Greenberg

Assistant Professor, Neurosurgery

Washington University School of Medicine

研究点 (2)

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