Semaglutide for Low Back Pain
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorWashington University School of Medicine
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Semaglutide (administered by PDS290 pen-injector)
- Placebo (administered by PDS290 pen-injector)
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
Washington University School of Medicine
Lead sponsor
Novo Nordisk A/S
Collaborator
Source ClinicalTrials.gov