Semaglutide for Chronic Low Back Pain and Obesity

This study is investigating whether Semaglutide, a medication already used for weight loss, can help reduce chronic low back pain in adults who also have obesity. Researchers believe Semaglutide might help by reducing weight and through other actions in the body. You could be eligible if you are between 18 and 85 years old, have chronic low back pain (lasting at least 3 months), and have a BMI (Body Mass Index) between 30 and 49 kg/m2. The study aims to enroll 250 participants and will measure changes in your low back pain severity over 52 weeks to see if Semaglutide is effective. The current status of this study is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study involving 250 participants. Participants will be randomly assigned to receive either Semaglutide or a placebo.
What's involved
Participants will receive weekly subcutaneous injections for 52 weeks, with the dose gradually increasing over time. Pain severity will be measured at the beginning and throughout the 52 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 52 weeks to assess changes in pain severity.

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NCT07731256

Semaglutide for Low Back Pain

Not Yet Recruiting
PHASE2Ages 18–85InterventionalTreatment
Washington University School of Medicine
~250 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:Semaglutide (administered by PDS290 pen-injector)Placebo (administered by PDS290 pen-injector)

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
BPI-SF Pain Severity Scale
Measured over Baseline, up to 52 weeks
Lower Back Pain
Obesity (BMI>30)
Chronic Lower Back Pain
glp1 Agonist
2 sites across 2 states
Alabama1
Missouri1
  • Jacob K Greenberg, MD, MSCI · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
  • Burel R Goodin, PhD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

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Eligibility criteria

Inclusion

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

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.
  • BPI-SF Pain Severity ScaleBaseline, 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.