Indexing hint: Randomized controlled trial · 2024
Once-Weekly Semaglutide in Persons with Obesity and Knee Osteoarthritis.
Bliddal et al. 2024The New England journal of medicinecited by 261
PMID 39476339DOI 10.1056/nejmoa2403664PUB-39476339
Trial · Interventional
Not yet recruitingPhase 2Registry dataUnited States
1 trial · 1 not yet recruiting
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Active comparator
Semaglutide Group
The experimental group will receive Semaglutide 2.4 mg subcutaneously administered on the same day weekly at any time of the day without regard to meals. To achieve the weekly 2.4 mg maintenance dose, subjects will start at 0.24 mg weekly for 28 days and then increase to 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg every 4 weeks. The clinical pen is a 3 mL PDS290 pen-injector containing Semaglutide 3.0 mg/mL for subcutaneous use. Treatment duration is 52 weeks.
Placebo comparator
Placebo Group
The placebo group will receive a matched placebo administered subcutaneously on the same day weekly at any time of the day without regard to meals, following the same escalating dose schedule as the active comparator. The clinical pen is a 3 mL PDS290 pen-injector containing placebo solution for subcutaneous use. Treatment duration is 52 weeks.
Outcomes the sponsor listed as primary.
BPI-SF Pain Severity Scale
Time frame · 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.
BPI-SF Pain Interference
Time frame · Baseline, up to 52 weeks
Oswestry Disability Index (ODI)
Time frame · Baseline, up to 52 weeks
SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS)
Time frame · Baseline, up to 52 weeks
PROMIS Depression
Time frame · Baseline, up to 52 weeks
Pain Catastrophizing Scale
Time frame · Baseline, up to 52 weeks
Insomnia Severity Index
Time frame · Baseline, up to 52 weeks
PROMIS Sleep Disturbance
Time frame · Baseline, up to 52 weeks
Waist Circumference
Time frame · Baseline, up to 52 weeks
Number of New Concomitant Back Pain Treatments
Time frame · Baseline, up to 52 weeks
The number and type of new low back pain treatments initiated during the study period, captured using the study's Concomitant Back Pain Treatment Log. New daily pain medications, exercise/therapy regimens, cognitive/behavioral interventions, spinal injections, interventional pain procedures, lumbar spine surgery, and other treatments.
Change in Serum High-Sensitivity C-Reactive Protein (hs-CRP)
Time frame · Baseline, every 6 months till 52 weeks.
Serum hs-CRP will be measured at each time point and reported in mg/L. Additional exploratory inflammatory blood biomarkers may also be assessed to characterize systemic inflammation.
Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame · Baseline, up to 52 weeks
Change in serum Leptin levels
Time frame · Baseline, every 6 months till 52 weeks.
Serum leptin will be measured at each time point and reported in ng/mL.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
2 studies on this page
Indexing hint: Randomized controlled trial · 2024
Bliddal et al. 2024The New England journal of medicinecited by 261
PMID 39476339DOI 10.1056/nejmoa2403664PUB-39476339
Indexing hint: Randomized controlled trial · 2023
Garvey et al. 2023Lancet (London, England)cited by 604
PMID 37385275DOI 10.1016/s0140-6736(23)01200-xPUB-37385275
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