Semaglutide for Low Back Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Jacob K Greenberg, MD, MSCI
Principal Investigator
Washington University School of Medicine
Burel R Goodin, PhD
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for adults who have both chronic low back pain and obesity. Participants must be able to use a weekly injection and commit to the study for about one year.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Semaglutide
Trial Overview
The study compares weekly injections of Semaglutide (a weight loss medication) with placebo injections over 52 weeks, to see if Semaglutide can reduce low back pain severity in people with obesity. Participants are randomly assigned to either group without knowing which they receive.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Novo Nordisk A/S
Industry Sponsor
Lars Fruergaard Jørgensen
Novo Nordisk A/S
Chief Executive Officer since 2017
MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark
Martin Holst Lange
Novo Nordisk A/S
Chief Medical Officer since 2021
MD from University of Copenhagen
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