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Semaglutide for Low Back Pain

ConditionsLower Back PainObesity (BMI>30)Chronic Lower Back Painglp1 Agonist
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Semaglutide GroupActive comparator 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

BPI-SF Pain Severity Scale

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.

Time frame
Baseline, up to 52 weeks

Secondary outcomes

1

BPI-SF Pain Interference

Time frame
Baseline, up to 52 weeks
2

Oswestry Disability Index (ODI)

Time frame
Baseline, up to 52 weeks
3

SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS)

Time frame
Baseline, up to 52 weeks
4

PROMIS Depression

Time frame
Baseline, up to 52 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

Novo Nordisk A/S

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: