Not yet taking people in United StatesPhase 2

Testing semaglutide for long-term back pain in adults with obesity

Compares a weekly weight-loss injection with a dummy shot in adults with back pain.

Key facts

Who runs it: Washington University School of Medicine
Where: Birmingham and St Louis, United StatesSee the 2 sites
Trial code: NCT07731256
Registry title: Semaglutide for Low Back Pain
Status: Not yet recruiting
Phase: Phase 2
People taking part: 250 people, planned
Starts: 1 Feb 2027
Expected to end: 1 Sept 2031
Type of study: Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested: Semaglutide (administered by PDS290 pen-injector)
Placebo (administered by PDS290 pen-injector)
Record updated: 28 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with long-lasting low back pain and obesity. Half get weekly semaglutide 2.4 mg and half get a placebo for 52 weeks.

Age: 18 to 85 years
Sex: All sexes can join.
Disease stage: Chronic low back pain: average pain of at least 4/10 on most days for 3 months or longer. BMI 30-49 kg/m2.
Earlier treatment: No GLP-1 receptor agonist (oral or injectable) in the 3 months before screening. No bariatric weight loss surgery, past or planned.

Main reasons for not taking part

Pregnant, breastfeeding, or planning pregnancy
Diabetes with HbA1c above 7 or needing medicine other than metformin
Back pain caused by infection, injury or cancer, or surgery being considered for a structural cause
Personal history of MEN2, or personal or family history of medullary thyroid cancer
Pancreatitis, active gallstone disease, or kidney disease stage 3 or worse

The registry criteria, word for word

Show all 32 criteriaShow less

Who can take part

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

Who cannot take part

Contraindications to study medication(s), worded specifically as stated in the product's Prescribing Information
Previous randomization in this trial
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
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
Known active gallstone disease, other than disease previously treated with cholecystectomy
Impaired sensorium due to alcohol or drug use
Known or suspected allergy to trial medication(s), excipients, or related products
Low back pain related to infection, trauma, or malignancy
History of or plans to undergo bariatric weight loss surgery
History of a major abdominal or stomach surgery that might affect drug absorption
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
Active acute or chronic pancreatitis diagnosed within 180 days or history of unprovoked pancreatitis within the past year
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
History of diabetes mellitus, with HbA1c > 7 or requiring medical treatment (i.e., insulin or other diabetes medication other than Metformin)
Stage 3 or worse chronic kidney disease (i.e., eGFR < 60)
Pregnant, breastfeeding, or the intention of becoming pregnant or not using adequate contraceptive measures
Plans to undergo new back pain interventions within 3 months
Another source of pain that is more severe than their low back pain (e.g., headache or radiculopathy)
Decrease in body weight of > 5 kg within 3 months of screening

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 85 years old?

Where in United States

The University of Alabama at BirminghamBirmingham, United StatesContact: Tammie Quinn, MANot yet recruiting
Washington University School of MedicineSt Louis, United StatesContact: Elizabeth Wilson, MS, CCRPNot yet recruiting

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

Semaglutide GroupExisting treatment, for comparison
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.
Treatment: Semaglutide (administered by PDS290 pen-injector)
Placebo GroupPlacebo, for comparison
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.
Treatment: Placebo (administered by PDS290 pen-injector)