Semaglutide for Low Back Pain | NCT07731256

NCT07731256

Overview

NCT ID: NCT07731256
Lead Sponsor: Washington University School of MedicineOTHER
Official Title: A Randomized-Controlled Trial of Semaglutide for Patients With Chronic Low Back Pain and Obesity
Brief Summary: 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.
Conditions: Lower Back Pain
Obesity (BMI>30)
Chronic Lower Back Pain

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 28, 2026Actual
Start Date: Feb 1, 2027Estimated
Primary Completion Date: Jan 1, 2031Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Phase 2
Enrollment: 250Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Contacts and Locations

Central Contacts: Elizabeth Wilson, MS, CCRPContact
lizwilson@wustl.edu314-722-0896

Similar Studies

Participant Group/Arms

Semaglutide GroupActive Comparator

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.

Drug: Semaglutide (administered by PDS290 pen-injector)

Placebo GroupPlacebo Comparator

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.

Drug: Placebo (administered by PDS290 pen-injector)