Semaglutide for Low Back Pain

Официальное название

A Randomized-Controlled Trial of Semaglutide for Patients With Chronic Low Back Pain and Obesity

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• BPI-SF Pain Severity Scale [Срок оценки: Baseline, up to 52 weeks]

Вторичные конечные точки (12)

• BPI-SF Pain Interference [Срок оценки: Baseline, up to 52 weeks]
• Oswestry Disability Index (ODI) [Срок оценки: Baseline, up to 52 weeks]
• SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS) [Срок оценки: Baseline, up to 52 weeks]
• PROMIS Depression [Срок оценки: Baseline, up to 52 weeks]
• Pain Catastrophizing Scale [Срок оценки: Baseline, up to 52 weeks]
• Insomnia Severity Index [Срок оценки: Baseline, up to 52 weeks]
• PROMIS Sleep Disturbance [Срок оценки: Baseline, up to 52 weeks]
• Waist Circumference [Срок оценки: Baseline, up to 52 weeks]
• Number of New Concomitant Back Pain Treatments [Срок оценки: Baseline, up to 52 weeks]
• Change in Serum High-Sensitivity C-Reactive Protein (hs-CRP) [Срок оценки: Baseline, every 6 months till 52 weeks.]
• Treatment Satisfaction Questionnaire for Medication (TSQM) [Срок оценки: Baseline, up to 52 weeks]
• Change in serum Leptin levels [Срок оценки: Baseline, every 6 months till 52 weeks.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• The University of Alabama at Birmingham — Birmingham
• Washington University School of Medicine — St Louis

Публикации

• 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, Wil PMID 32520773
• 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/ejp.1811. Epub 2021 Jun 21. PMID 34051018
• 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/S0140-6736(23)0120 PMID 37385275
• 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/M16-23 PMID 28192789
• Chiarotto 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. PMID 35507483
• Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38. PMID 8080219
• 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/s10194-025-01979-4. PMID 40016636
• 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: 10.1080/17581869.2024.2402214. Epub 2024 Sep 20. PMID 39301951

Идентификаторы

NCT: NCT07731256 · U1111-1323-5378

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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