Not yet recruitingPhase 2
Semaglutide for Low Back Pain
A Randomized-Controlled Trial of Semaglutide for Patients With Chronic Low Back Pain and Obesity
Lead sponsor
Asset
Semaglutide
GLP-1 agonist
Listed sites
2
Recruiting sites
-
Estimated enrollment
250
Study population
Obesity / overweight
Eligibility highlights
•BMI 30-49
Primary endpoint
-
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
NCT IDNCT07731256
Org study IDU1111-1323-5378
Timeline
Milestones
Study first posted2026-07-28actual
Last update posted2026-07-28actual
Study start2027-02-01estimated
Primary completion2031-01-01estimated
Study completion2031-09-01estimated
Assets
Investigational agents
Who this study enrolls
Obesity / overweight
Who can enroll
Minimum age18 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted
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.
Endpoints (0)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
No endpoints recorded for this trial.
Provenance
Sources
Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.