Semaglutide for Low Back Pain

Prior treatment

• Contraindications to study medication(s), worded specifically as stated in the product's Prescribing Information
• Previous randomization in this trial
• 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.
• 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
• Known active gallstone disease, other than disease previously treated with cholecystectomy.
• Impaired sensorium due to alcohol or drug use.

Other illness

• Known or suspected allergy to trial medication(s), excipients, or related products
• Low back pain related to infection, trauma, or malignancy
• History of or plans to undergo bariatric weight loss surgery
• History of a major abdominal or stomach surgery that might affect drug absorption
• 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.
• Active acute or chronic pancreatitis diagnosed within 180 days or history of unprovoked pancreatitis within the past year.
• 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

Lab values

• History of diabetes mellitus, with HbA1c \> 7 or requiring medical treatment (i.e., insulin or other diabetes medication other than Metformin).
• Stage 3 or worse chronic kidney disease (i.e., eGFR \< 60).

Other

• Pregnant, breastfeeding, or the intention of becoming pregnant or not using adequate contraceptive measures
• Plans to undergo new back pain interventions within 3 months.
• Another source of pain that is more severe than their low back pain (e.g., headache or radiculopathy)
• Decrease in body weight of \> 5 kg within 3 months of screening

• 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