Glycemic and Weight Loss Effects of GLP-1R Agonist Therapy in Subjects With Spinal Cord Injury an… (NCT06706284) | Clinical Trial Compass
RecruitingPhase 4
Glycemic and Weight Loss Effects of GLP-1R Agonist Therapy in Subjects With Spinal Cord Injury and Type 2 Diabetes
United States50 participantsStarted 2025-04-11
Plain-language summary
It is not known whether a new diabetes drug, semaglutide, is an effective treatment for type 2 diabetes for persons with spinal cord injury (SCI), a population at higher risk for this condition. Therefore, this study looks at the effect of semaglutide on glucose levels in the body and other information about type 2 diabetes and obesity.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and female subjects aged 18-70 years (inclusive) at screening
. More than one year after spinal cord injury
. Levels if injury C2-L2 with Asia Impairment Scale A, B, C or D.
. Provision of signed and dated written informed consent prior to any study specific procedures
. Diagnosed with T2DM with glucose control managed with diet and metformin monotherapy where no significant dose changes (increase or decrease ≥ 50%) have occurred in the three months prior to screening
. HbA1c 6.0-9.0% at screening
. BMI \> 22 kg/m2 at screening
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Female subjects of childbearing potential must have a negative pregnancy test at screening and randomization, and must not be lactating
Exclusion criteria
. History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, put the subject at risk, influence the subject's ability to participate or affect the interpretation of the results of the study and/or any subject unable or unwilling to follow study procedures.
. Any subject who has received another investigational product as part of a clinical study within the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening
. Taking mirabegron or other glucose altering medications
. Taking steroids within the past 1 year
. Significant anemia (hemoglobin\<11g/dL)
. History of gastric outlet obstruction or chronic diarrhea
. History of a chronic neurological illness other than SCI (i.e.; MS, etc)
. Any subject who has received any of the following medications within the specified time-frame prior to the start of the study