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 range18 Years – 70 Years
SexALL
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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
✓. 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