Skip to content

Trial · Interventional

Not yet recruitingPhase 2Registry data

Semaglutide for Low Back Pain

Overview

Status
Not yet recruiting
Phase
Phase 2
Enrollment
250 participants (estimated)
Sponsor
Washington University School of Medicine · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
1 Feb 2027 (estimated)
Primary completion
1 Jan 2031 (estimated)
Completion
1 Sept 2031 (estimated)
First posted
28 Jul 2026
Last update posted
28 Jul 2026
Conditions
Lower Back Pain · Obesity (BMI>30) · Chronic Lower Back Pain · glp1 Agonist

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202720282029203020312032
  1. Ph 2

    Semaglutide for Low Back Pain

    NCT07731256

    est. 1 Feb 2027 to est. 1 Sept 2031

Registry summary

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.

Interventions

  • Semaglutide (administered by PDS290 pen-injector)Drug
  • Placebo (administered by PDS290 pen-injector)Drug

Arms2

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. BPI-SF Pain Severity Scale

    Time frame · Baseline, up to 52 weeks

    Registry description

    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.

Secondary outcomes(12)
  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

  5. Pain Catastrophizing Scale

    Time frame · Baseline, up to 52 weeks

  6. Insomnia Severity Index

    Time frame · Baseline, up to 52 weeks

  7. PROMIS Sleep Disturbance

    Time frame · Baseline, up to 52 weeks

  8. Waist Circumference

    Time frame · Baseline, up to 52 weeks

  9. Number of New Concomitant Back Pain Treatments

    Time frame · Baseline, up to 52 weeks

    Registry description

    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.

  10. Change in Serum High-Sensitivity C-Reactive Protein (hs-CRP)

    Time frame · Baseline, every 6 months till 52 weeks.

    Registry description

    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.

  11. Treatment Satisfaction Questionnaire for Medication (TSQM)

    Time frame · Baseline, up to 52 weeks

  12. Change in serum Leptin levels

    Time frame · Baseline, every 6 months till 52 weeks.

    Registry description

    Serum leptin will be measured at each time point and reported in ng/mL.

Posted results

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

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2024

6 results

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

Full text at the publisher6 results

Indexing hint: Randomized controlled trial · 2023

9 results

Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial.

Garvey et al. 2023Lancet (London, England)cited by 604

PMID 37385275DOI 10.1016/s0140-6736(23)01200-xPUB-37385275

Rights unknown9 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

PepBank is a research reference. Talk to a doctor before you use any peptide.