Semaglutide for Low Back Pain

NCT07731256 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: U1111-1323-5378
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

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; glp1 Agonist

Keywords

Lower back pain; Obesity; Chronic Lower Back Pain; GLP1 Agonist

Outcome Measures

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.

  Baseline, up to 52 weeks

Secondary Outcomes (12)

• BPI-SF Pain Interference

  Baseline, up to 52 weeks

• Oswestry Disability Index (ODI)

  Baseline, up to 52 weeks

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

  Baseline, up to 52 weeks

• PROMIS Depression

  Baseline, up to 52 weeks

• Pain Catastrophizing Scale

  Baseline, up to 52 weeks

Study Arms (2)

Semaglutide Group

ACTIVE 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 Group

PLACEBO 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)

Interventions

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.

Semaglutide Group

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.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Novo Nordisk A/S: collaborator

Study Sites (2)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

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MeSH Terms

Conditions

Low Back Pain; Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Study Officials

• Jacob K Greenberg, MD, MSCI

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Burel R Goodin, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Wilson, MS, CCRP

CONTACT

314-722-0896; lizwilson@wustl.edu

Faraz Arkam, MD

CONTACT

314-273-9224; arkam@wustl.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Neurosurgery

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 28, 2026
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): September 1, 2031
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (2)