Opening soonPhase 2Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 85 Years
SexAll
Healthy volunteersNot accepted
ConditionLower Back Pain, Obesity (BMI>30), Chronic Lower Back Pain, glp1 Agonist
Full registry criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Treatments and study arms
Semaglutide (administered by PDS290 pen-injector)
Drug
Semaglutide 3.0 mg/mL solution for subcutaneous injection, administered using a 3 mL PDS290 pen-injector. Administered subcutaneously once weekly on the same day each week, without regard to meals. Dose escalation: 0.24 mg weekly for 28 days, then increased to 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg every 4 weeks to reach the maintenance dose of 2.4 mg. The pen uses a drum scale of 1-80 (in increments of 1); corresponding dose counter values are: 0.24 mg = 8, 0.5 mg = 17, 1.0 mg = 34, 1.7 mg = 57, 2.4 mg = 80. Treatment duration is 52 weeks.
Placebo (administered by PDS290 pen-injector)
Drug
Matching placebo solution for subcutaneous injection, administered using a 3 mL PDS290 pen-injector. Administered subcutaneously once weekly on the same day each week, without regard to meals, following the same escalating dose counter schedule as the active comparator (counter values: 8, 17, 34, 57, 80 every 4 weeks). Treatment duration is 52 weeks.
