Lower Back PainPhase 2NCT07731256
Semaglutide for Low Back Pain
A Phase 2 study testing Semaglutide (administered by PDS290 pen-injector) in people with Lower Back Pain and Obesity (BMI>30), run by Washington University School of Medicine at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lower Back Pain, Obesity (BMI>30), Chronic Lower Back Pain
- What is being tested?
- Semaglutide (administered by PDS290 pen-injector)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2027to 1 Sep 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Show all 28Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
Tammie Quinn, MA, 205-934-8743, tquinn@uab.edu
Robert E Sorge, PhD
Washington University School of Medicine
St Louis, Missouri, 63108
Elizabeth Wilson, MS, CCRP, 314-722-0896, lizwilson@wustl.edu
Faraz Arkam, MD, 314-591-9210, arkam@wustl.edu
About this study
Official title: A Randomized-Controlled Trial of Semaglutide for Patients With Chronic Low Back Pain and Obesity
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.
- Being tested
- Semaglutide (administered by PDS290 pen-injector), Placebo (administered by PDS290 pen-injector)
- Keywords
- Lower back pain, Obesity, Chronic Lower Back Pain, GLP1 Agonist
- Medical subject headings
- Low Back Pain, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo (administered by PDS290 pen-injector) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, up to 52 weeks
Secondary outcomes (12)
BPI-SF Pain Interference
Measured: Baseline, up to 52 weeks
Oswestry Disability Index (ODI)
Measured: Baseline, up to 52 weeks
SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS)
Measured: Baseline, up to 52 weeks
PROMIS Depression
Measured: Baseline, up to 52 weeks
Pain Catastrophizing Scale
Measured: Baseline, up to 52 weeks
Insomnia Severity Index
Measured: Baseline, up to 52 weeks
PROMIS Sleep Disturbance
Measured: Baseline, up to 52 weeks
Waist Circumference
Measured: Baseline, up to 52 weeks
Number of New Concomitant Back Pain Treatments
The number and type of new low back pain treatments initiated during the study period, captured using the study's Concomitant Back Pain Treatment Log.
New daily pain medications, exercise/therapy regimens, cognitive/behavioral interventions, spinal injections, interventional pain procedures, lumbar spine surgery, and other treatments.
Measured: Baseline, up to 52 weeks
Change in Serum High-Sensitivity C-Reactive Protein (hs-CRP)
Serum hs-CRP will be measured at each time point and reported in mg/L. Additional exploratory inflammatory blood biomarkers may also be assessed to characterize systemic inflammation.
Measured: Baseline, every 6 months till 52 weeks.
Treatment Satisfaction Questionnaire for Medication (TSQM)
Measured: Baseline, up to 52 weeks
Change in serum Leptin levels
Serum leptin will be measured at each time point and reported in ng/mL.
Measured: Baseline, every 6 months till 52 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Feb 2027 (estimated)
- Primary completion1 Jan 2031 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Lower Back PainStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Jacob Greenberg, Washington University School of Medicine
- Investigators
- Jacob K Greenberg, MD, MSCI, Principal investigator, Washington University School of MedicineBurel R Goodin, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731256
- Sponsor's protocol ID
- U1111-1323-5378
- Status last verified
- Jul 2026
- First submitted
- 28 Jun 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Smith SM, Dworkin RH, Turk DC, McDermott MP, Eccleston C, Farrar JT, Rowbotham MC, Bhagwagar Z, Burke LB, Cowan P, Ellenberg SS, Evans SR, Freeman RL, Garrison LP, Iyengar S, Jadad A, Jensen MP, Junor R, Kamp C, Katz NP, Kesslak JP, Kopecky EA, Lissin D, Markman JD, Mease PJ, O'Connor AB, Patel KV, Raja SN, Sampaio C, Schoenfeld D, Singh J, Steigerwald I, Strand V, Tive LA, Tobias J, Wasan AD, Wilson HD. Interpretation of chronic pain clinical trial outcomes: IMMPACT recommended considerations. Pain. 2020 Nov;161(11):2446-2461. doi: 10.1097/j.pain.0000000000001952.
PubMed 32520773van Lennep JHPA, Trossel F, Perez RSGM, Otten RHJ, van Middendorp H, Evers AWM, Szadek KM. Placebo effects in low back pain: A systematic review and meta-analysis of the literature. Eur J Pain. 2021 Oct;25(9):1876-1897. doi: 10.1002/ejp.1811. Epub 2021 Jun 21.
PubMed 34051018Garvey WT, Frias JP, Jastreboff AM, le Roux CW, Sattar N, Aizenberg D, Mao H, Zhang S, Ahmad NN, Bunck MC, Benabbad I, Zhang XM; SURMOUNT-2 investigators. Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2023 Aug 19;402(10402):613-626. doi: 10.1016/S0140-6736(23)01200-X. Epub 2023 Jun 26.
PubMed 37385275Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14.
PubMed 28192789Chiarotto A, Koes BW. Nonspecific Low Back Pain. N Engl J Med. 2022 May 5;386(18):1732-1740. doi: 10.1056/NEJMcp2032396. No abstract available.
PubMed 35507483Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
PubMed 8080219He Y, Xu B, Zhang M, Chen D, Wu S, Gao J, Liu Y, Zhang Z, Kuang J, Fang Q. Advances in GLP-1 receptor agonists for pain treatment and their future potential. J Headache Pain. 2025 Feb 27;26(1):46. doi: 10.1186/s10194-025-01979-4.
PubMed 40016636Samajdar SS, Bhaduri G, Ghoshal PK, Mukherjee S, Pal J, Chatterjee N, Joshi SR. Dual effects of dulaglutide on glycemic control and knee osteoarthritis pain in elderly patients with Type 2 diabetes. Pain Manag. 2024;14(7):365-373. doi: 10.1080/17581869.2024.2402214. Epub 2024 Sep 20.
PubMed 39301951Emmerich SD, Fryar CD, Stierman B, Ogden CL. Obesity and Severe Obesity Prevalence in Adults: United States, August 2021-August 2023. NCHS Data Brief. 2024 Sep;(508):10.15620/cdc/159281. doi: 10.15620/cdc/159281.
PubMed 39808758Shiri R, Karppinen J, Leino-Arjas P, Solovieva S, Viikari-Juntura E. The association between obesity and low back pain: a meta-analysis. Am J Epidemiol. 2010 Jan 15;171(2):135-54. doi: 10.1093/aje/kwp356. Epub 2009 Dec 11.
PubMed 20007994Jackson T, Thomas S, Stabile V, Shotwell M, Han X, McQueen K. A Systematic Review and Meta-Analysis of the Global Burden of Chronic Pain Without Clear Etiology in Low- and Middle-Income Countries: Trends in Heterogeneous Data and a Proposal for New Assessment Methods. Anesth Analg. 2016 Sep;123(3):739-48. doi: 10.1213/ANE.0000000000001389.
PubMed 27537761Xie Y, Choi T, Al-Aly Z. Mapping the effectiveness and risks of GLP-1 receptor agonists. Nat Med. 2025 Mar;31(3):951-962. doi: 10.1038/s41591-024-03412-w. Epub 2025 Jan 20.
PubMed 39833406Felson DT. Glucagon-Like Peptide-1 Receptor Agonists and Osteoarthritis. N Engl J Med. 2024 Oct 31;391(17):1643-1644. doi: 10.1056/NEJMe2409972. No abstract available.
PubMed 39476345Bliddal H, Bays H, Czernichow S, Udden Hemmingsson J, Hjelmesaeth J, Hoffmann Morville T, Koroleva A, Skov Neergaard J, Velez Sanchez P, Wharton S, Wizert A, Kristensen LE; STEP 9 Study Group. Once-Weekly Semaglutide in Persons with Obesity and Knee Osteoarthritis. N Engl J Med. 2024 Oct 31;391(17):1573-1583. doi: 10.1056/NEJMoa2403664.
PubMed 39476339Wharton S, Blevins T, Connery L, Rosenstock J, Raha S, Liu R, Ma X, Mather KJ, Haupt A, Robins D, Pratt E, Kazda C, Konig M; GZGI Investigators. Daily Oral GLP-1 Receptor Agonist Orforglipron for Adults with Obesity. N Engl J Med. 2023 Sep 7;389(10):877-888. doi: 10.1056/NEJMoa2302392. Epub 2023 Jun 23.
PubMed 37351564
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized-Controlled Trial of Semaglutide for Patients With Chronic Low Back Pain and Obesity
- ClinicalTrials.gov ID
- NCT07731256
- Acronym / sponsor ID
- U1111-1323-5378
- Keywords
- Lower back pain, Obesity, Chronic Lower Back Pain, GLP1 Agonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 1 Jan 2031 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide Group | Active comparator | Drug: Semaglutide (administered by PDS290 pen-injector)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. |
| Placebo Group | Placebo comparator | Drug: Placebo (administered by PDS290 pen-injector)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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide (administered by PDS290 pen-injector)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. | Drug | Semaglutide Group |
| Placebo (administered by PDS290 pen-injector)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. | Drug | Placebo Group |
Primary outcome
BPI-SF Pain Severity Scale
Time frame: Baseline, 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.
12 secondary outcomes
BPI-SF Pain Interference
Time frame: Baseline, up to 52 weeks
Oswestry Disability Index (ODI)
Time frame: Baseline, up to 52 weeks
SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS)
Time frame: Baseline, up to 52 weeks
PROMIS Depression
Time frame: Baseline, up to 52 weeks
Pain Catastrophizing Scale
Time frame: Baseline, up to 52 weeks
Insomnia Severity Index
Time frame: Baseline, up to 52 weeks
PROMIS Sleep Disturbance
Time frame: Baseline, up to 52 weeks
Waist Circumference
Time frame: Baseline, up to 52 weeks
Number of New Concomitant Back Pain Treatments
Time frame: Baseline, up to 52 weeks
Change in Serum High-Sensitivity C-Reactive Protein (hs-CRP)
Time frame: Baseline, every 6 months till 52 weeks.
Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: Baseline, up to 52 weeks
Change in serum Leptin levels
Time frame: Baseline, every 6 months till 52 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Background: PubMed 32520773Smith SM, Dworkin RH, Turk DC, McDermott MP, Eccleston C, Farrar JT, Rowbotham MC, Bhagwagar Z, Burke LB, Cowan P, Ellenberg SS, Evans SR, Freeman RL, Garrison LP, Iyengar S, Jadad A, Jensen MP, Junor R, Kamp C, Katz NP, Kesslak JP, Kopecky EA, Lissin D, Markman JD, Mease PJ, O'Connor AB, Patel KV, Raja SN, Sampaio C, Schoenfeld D, Singh J, Steigerwald I, Strand V, Tive LA, Tobias J, Wasan AD, Wilson HD. Interpretation of chronic pain clinical trial outcomes: IMMPACT recommended considerations. Pain. 2020 Nov;161(11):2446-2461. doi: 10.1097/j.pain.0000000000001952.
- Background: PubMed 34051018van Lennep JHPA, Trossel F, Perez RSGM, Otten RHJ, van Middendorp H, Evers AWM, Szadek KM. Placebo effects in low back pain: A systematic review and meta-analysis of the literature. Eur J Pain. 2021 Oct;25(9):1876-1897. doi: 10.1002/ejp.1811. Epub 2021 Jun 21.
- Background: PubMed 37385275Garvey WT, Frias JP, Jastreboff AM, le Roux CW, Sattar N, Aizenberg D, Mao H, Zhang S, Ahmad NN, Bunck MC, Benabbad I, Zhang XM; SURMOUNT-2 investigators. Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2023 Aug 19;402(10402):613-626. doi: 10.1016/S0140-6736(23)01200-X. Epub 2023 Jun 26.
- Background: PubMed 28192789Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14.
- Background: PubMed 35507483Chiarotto A, Koes BW. Nonspecific Low Back Pain. N Engl J Med. 2022 May 5;386(18):1732-1740. doi: 10.1056/NEJMcp2032396. No abstract available.
- Background: PubMed 8080219Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
- Background: PubMed 40016636He Y, Xu B, Zhang M, Chen D, Wu S, Gao J, Liu Y, Zhang Z, Kuang J, Fang Q. Advances in GLP-1 receptor agonists for pain treatment and their future potential. J Headache Pain. 2025 Feb 27;26(1):46. doi: 10.1186/s10194-025-01979-4.
- Background: PubMed 39301951Samajdar SS, Bhaduri G, Ghoshal PK, Mukherjee S, Pal J, Chatterjee N, Joshi SR. Dual effects of dulaglutide on glycemic control and knee osteoarthritis pain in elderly patients with Type 2 diabetes. Pain Manag. 2024;14(7):365-373. doi: 10.1080/17581869.2024.2402214. Epub 2024 Sep 20.
- Background: PubMed 39808758Emmerich SD, Fryar CD, Stierman B, Ogden CL. Obesity and Severe Obesity Prevalence in Adults: United States, August 2021-August 2023. NCHS Data Brief. 2024 Sep;(508):10.15620/cdc/159281. doi: 10.15620/cdc/159281.
- Background: PubMed 20007994Shiri R, Karppinen J, Leino-Arjas P, Solovieva S, Viikari-Juntura E. The association between obesity and low back pain: a meta-analysis. Am J Epidemiol. 2010 Jan 15;171(2):135-54. doi: 10.1093/aje/kwp356. Epub 2009 Dec 11.
- Background: PubMed 27537761Jackson T, Thomas S, Stabile V, Shotwell M, Han X, McQueen K. A Systematic Review and Meta-Analysis of the Global Burden of Chronic Pain Without Clear Etiology in Low- and Middle-Income Countries: Trends in Heterogeneous Data and a Proposal for New Assessment Methods. Anesth Analg. 2016 Sep;123(3):739-48. doi: 10.1213/ANE.0000000000001389.
- Background: PubMed 39833406Xie Y, Choi T, Al-Aly Z. Mapping the effectiveness and risks of GLP-1 receptor agonists. Nat Med. 2025 Mar;31(3):951-962. doi: 10.1038/s41591-024-03412-w. Epub 2025 Jan 20.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacob K Greenberg, MD, MSCI principal investigator
Washington University School of Medicine
Burel R Goodin, PhD principal investigator
Washington University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Semaglutide (administered by PDS290 pen-injector) in people with Lower Back Pain and Obesity (BMI>30), run by Washington University School of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Wilson, MS, CCRP (314-722-0896, lizwilson@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BPI-SF Pain Severity Scale (time frame: Baseline, up to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07731256, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.