[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07731256":3,"trial-entities:NCT07731256":238,"trial-summary:NCT07731256":242},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":46,"secondary_outcomes":51,"sex":80,"minimum_age":81,"maximum_age":82,"healthy_volunteers":83,"eligibility_criteria":84,"std_ages":120,"locations":123,"central_contacts":165,"overall_officials":169,"references":172,"see_also_links":237},"NCT07731256","U1111-1323-5378","Semaglutide for Low Back Pain","A Randomized-Controlled Trial of Semaglutide for Patients With Chronic Low Back Pain and Obesity","NOT_YET_RECRUITING","2031-09-01","2026-07","2026-07-28","2027-02-01","Washington University School of Medicine","OTHER",true,"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.",null,[19,20,21,22],"Lower Back Pain","Obesity (BMI>30)","Chronic Lower Back Pain","glp1 Agonist",[24,25,21,26],"Lower back pain","Obesity","GLP1 Agonist","INTERVENTIONAL","TREATMENT",[30],"PHASE2",{"count":32,"type":33},250,"ESTIMATED",[35,41],{"type":36,"name":37,"description":38,"armGroupLabels":39},"DRUG","Semaglutide (administered by PDS290 pen-injector)","Semaglutide 3.0 mg\u002FmL 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.",[40],"Semaglutide Group",{"type":36,"name":42,"description":43,"armGroupLabels":44},"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.",[45],"Placebo Group",[47],{"measure":48,"description":49,"timeFrame":50},"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",[52,54,56,58,60,62,64,66,68,71,75,77],{"measure":53,"timeFrame":50},"BPI-SF Pain Interference",{"measure":55,"timeFrame":50},"Oswestry Disability Index (ODI)",{"measure":57,"timeFrame":50},"SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS)",{"measure":59,"timeFrame":50},"PROMIS Depression",{"measure":61,"timeFrame":50},"Pain Catastrophizing Scale",{"measure":63,"timeFrame":50},"Insomnia Severity Index",{"measure":65,"timeFrame":50},"PROMIS Sleep Disturbance",{"measure":67,"timeFrame":50},"Waist Circumference",{"measure":69,"description":70,"timeFrame":50},"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.\n\nNew daily pain medications, exercise\u002Ftherapy regimens, cognitive\u002Fbehavioral interventions, spinal injections, interventional pain procedures, lumbar spine surgery, and other treatments.",{"measure":72,"description":73,"timeFrame":74},"Change in Serum High-Sensitivity C-Reactive Protein (hs-CRP)","Serum hs-CRP will be measured at each time point and reported in mg\u002FL. Additional exploratory inflammatory blood biomarkers may also be assessed to characterize systemic inflammation.","Baseline, every 6 months till 52 weeks.",{"measure":76,"timeFrame":50},"Treatment Satisfaction Questionnaire for Medication (TSQM)",{"measure":78,"description":79,"timeFrame":74},"Change in serum Leptin levels","Serum leptin will be measured at each time point and reported in ng\u002FmL.","ALL","18 Years","85 Years",false,{"inclusion":85,"exclusion":90,"raw_text":119},[86,87,88,89],"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\u002F10 present on most days for 3 months or longer.","BMI: 30-49 kg\u002Fm2",[91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118],"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 \\\u003C 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.","Inclusion Criteria:\n\n* Ability to provide informed consent before any trial-related activities\n* Age: 18-85 years\n* Chronic low back pain, defined as an average low back pain severity of at least 4\u002F10 present on most days for 3 months or longer.\n* BMI: 30-49 kg\u002Fm2\n\nExclusion Criteria:\n\n* Known or suspected allergy to trial medication(s), excipients, or related products\n* Contraindications to study medication(s), worded specifically as stated in the product's Prescribing Information\n* Previous randomization in this trial\n* Pregnant, breastfeeding, or the intention of becoming pregnant or not using adequate contraceptive measures\n* Low back pain related to infection, trauma, or malignancy\n* Plans to undergo new back pain interventions within 3 months.\n* 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.\n* Another source of pain that is more severe than their low back pain (e.g., headache or radiculopathy)\n* History of or plans to undergo bariatric weight loss surgery\n* History of a major abdominal or stomach surgery that might affect drug absorption\n* Decrease in body weight of \\> 5 kg within 3 months of screening\n* History of diabetes mellitus, with HbA1c \\> 7 or requiring medical treatment (i.e., insulin or other diabetes medication other than Metformin).\n* Uncontrolled hypertension, defined as a systolic blood pressure (BP) \\> 155 mmHg or a diastolic BP \\> 100 mmHg\n* 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.\n* Any of the following: myocardial infarction, stroke, hospitalization for unstable angina pectoris, or transient ischemic attack within 90 days of screening.\n* Other medical conditions that could impact their treatment, similar to prior published reports\n* Treatment with oral or injectable glucagon-like peptide-1 (GLP-1) receptor agonists within 3 months before screening\n* Active acute or chronic pancreatitis diagnosed within 180 days or history of unprovoked pancreatitis within the past year.\n* Stage 3 or worse chronic kidney disease (i.e., eGFR \\\u003C 60).\n* Known active gallstone disease, other than disease previously treated with cholecystectomy.\n* Newly diagnosed or worsening chronic liver disease.\n* Active malignancy\n* Major neurological disease, such as multiple sclerosis or Parkinson's Disease\n* Major psychiatric disease, such as psychosis or schizophrenia, or a psychiatric disease requiring hospitalization in the preceding 12 months\n* History of a suicide attempt or any reported suicidal behavior reported within 30 days of screening.\n* Personal history of MEN2\n* Personal or family history of medullary thyroid cancer\n* Impaired sensorium due to alcohol or drug use.",[121,122],"ADULT","OLDER_ADULT",[124,145],{"facility":125,"city":126,"state":127,"zip":128,"country":129,"contacts":130,"geoPoint":142},"The University of Alabama at Birmingham","Birmingham","Alabama","35294","United States",[131,136,139],{"name":132,"role":133,"phone":134,"email":135},"Tammie Quinn, MA","CONTACT","205-934-8743","tquinn@uab.edu",{"name":137,"role":138},"Robert E Sorge, PhD","PRINCIPAL_INVESTIGATOR",{"name":140,"role":141},"Jakub Godzik, MD, MS","SUB_INVESTIGATOR",{"lat":143,"lon":144},33.52066,-86.80249,{"facility":13,"city":146,"state":147,"zip":148,"country":129,"contacts":149,"geoPoint":162},"St Louis","Missouri","63108",[150,154,158,160],{"name":151,"role":133,"phone":152,"email":153},"Elizabeth Wilson, MS, CCRP","314-722-0896","lizwilson@wustl.edu",{"name":155,"role":133,"phone":156,"email":157},"Faraz Arkam, MD","314-591-9210","arkam@wustl.edu",{"name":159,"role":138},"Jacob K Greenberg, MD, MSCI",{"name":161,"role":138},"Burel R Goodin, PhD",{"lat":163,"lon":164},38.62727,-90.19789,[166,167],{"name":151,"role":133,"phone":152,"email":153},{"name":155,"role":133,"phone":168,"email":157},"314-273-9224",[170,171],{"name":159,"affiliation":13,"role":138},{"name":161,"affiliation":13,"role":138},[173,177,180,183,186,189,192,195,198,201,204,207,210,213,216,219,222,225,228,231,234],{"pmid":174,"type":175,"citation":176},"32520773","BACKGROUND","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\u002Fj.pain.0000000000001952.",{"pmid":178,"type":175,"citation":179},"34051018","van 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\u002Fejp.1811. Epub 2021 Jun 21.",{"pmid":181,"type":175,"citation":182},"37385275","Garvey 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\u002FS0140-6736(23)01200-X. Epub 2023 Jun 26.",{"pmid":184,"type":175,"citation":185},"28192789","Qaseem 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\u002FM16-2367. Epub 2017 Feb 14.",{"pmid":187,"type":175,"citation":188},"35507483","Chiarotto A, Koes BW. Nonspecific Low Back Pain. N Engl J Med. 2022 May 5;386(18):1732-1740. doi: 10.1056\u002FNEJMcp2032396. No abstract available.",{"pmid":190,"type":175,"citation":191},"8080219","Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.",{"pmid":193,"type":175,"citation":194},"40016636","He 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\u002Fs10194-025-01979-4.",{"pmid":196,"type":175,"citation":197},"39301951","Samajdar 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\u002F17581869.2024.2402214. Epub 2024 Sep 20.",{"pmid":199,"type":175,"citation":200},"39808758","Emmerich 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\u002Fcdc\u002F159281. doi: 10.15620\u002Fcdc\u002F159281.",{"pmid":202,"type":175,"citation":203},"20007994","Shiri 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\u002Faje\u002Fkwp356. Epub 2009 Dec 11.",{"pmid":205,"type":175,"citation":206},"27537761","Jackson 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\u002FANE.0000000000001389.",{"pmid":208,"type":175,"citation":209},"39833406","Xie 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\u002Fs41591-024-03412-w. Epub 2025 Jan 20.",{"pmid":211,"type":175,"citation":212},"39476345","Felson DT. Glucagon-Like Peptide-1 Receptor Agonists and Osteoarthritis. N Engl J Med. 2024 Oct 31;391(17):1643-1644. doi: 10.1056\u002FNEJMe2409972. No abstract available.",{"pmid":214,"type":175,"citation":215},"39476339","Bliddal 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\u002FNEJMoa2403664.",{"pmid":217,"type":175,"citation":218},"37351564","Wharton 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\u002FNEJMoa2302392. Epub 2023 Jun 23.",{"pmid":220,"type":175,"citation":221},"36662529","Chen N, Fong DYT, Wong JYH. Health and Economic Outcomes Associated With Musculoskeletal Disorders Attributable to High Body Mass Index in 192 Countries and Territories in 2019. JAMA Netw Open. 2023 Jan 3;6(1):e2250674. doi: 10.1001\u002Fjamanetworkopen.2022.50674.",{"pmid":223,"type":175,"citation":224},"31797139","Elgaeva EE, Tsepilov Y, Freidin MB, Williams FMK, Aulchenko Y, Suri P. ISSLS Prize in Clinical Science 2020. Examining causal effects of body mass index on back pain: a Mendelian randomization study. Eur Spine J. 2020 Apr;29(4):686-691. doi: 10.1007\u002Fs00586-019-06224-6. Epub 2019 Dec 3.",{"pmid":226,"type":175,"citation":227},"35606809","Chen LH, Weber K, Mehrabkhani S, Baskaran S, Abbass T, Macedo LG. The effectiveness of weight loss programs for low back pain: a systematic review. BMC Musculoskelet Disord. 2022 May 23;23(1):488. doi: 10.1186\u002Fs12891-022-05391-w.",{"pmid":229,"type":175,"citation":230},"32125402","Dieleman JL, Cao J, Chapin A, Chen C, Li Z, Liu A, Horst C, Kaldjian A, Matyasz T, Scott KW, Bui AL, Campbell M, Duber HC, Dunn AC, Flaxman AD, Fitzmaurice C, Naghavi M, Sadat N, Shieh P, Squires E, Yeung K, Murray CJL. US Health Care Spending by Payer and Health Condition, 1996-2016. JAMA. 2020 Mar 3;323(9):863-884. doi: 10.1001\u002Fjama.2020.0734.",{"pmid":232,"type":175,"citation":233},"29573870","Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016\u002FS0140-6736(18)30480-X. Epub 2018 Mar 21.",{"pmid":235,"type":175,"citation":236},"37273833","GBD 2021 Low Back Pain Collaborators. Global, regional, and national burden of low back pain, 1990-2020, its attributable risk factors, and projections to 2050: a systematic analysis of the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023 May 22;5(6):e316-e329. doi: 10.1016\u002FS2665-9913(23)00098-X. eCollection 2023 Jun.",[],{"nct_id":4,"conditions":239,"biomarkers":241},[240,25],"Chronic low back pain",[],{"nct_id":4,"found":15,"summary":243,"prompt_version":253},{"design":244,"status":245,"heading":246,"summary":247,"follow_up":248,"word_count":249,"commitments":250,"compensation":251,"drugs_mentioned":252},"This is a randomized, double-blind, placebo-controlled study involving 250 participants. Participants will be randomly assigned to receive either Semaglutide or a placebo.","completed","Semaglutide for Chronic Low Back Pain and Obesity","This study is investigating whether Semaglutide, a medication already used for weight loss, can help reduce chronic low back pain in adults who also have obesity. Researchers believe Semaglutide might help by reducing weight and through other actions in the body. You could be eligible if you are between 18 and 85 years old, have chronic low back pain (lasting at least 3 months), and have a BMI (Body Mass Index) between 30 and 49 kg\u002Fm2. The study aims to enroll 250 participants and will measure changes in your low back pain severity over 52 weeks to see if Semaglutide is effective. The current status of this study is unclear.","Participants will be followed for up to 52 weeks to assess changes in pain severity.",110,"Participants will receive weekly subcutaneous injections for 52 weeks, with the dose gradually increasing over time. Pain severity will be measured at the beginning and throughout the 52 weeks.","Not stated in the trial record.",[],"v2"]