Actively Recruiting
Glycemic and Weight Loss Effects of GLP-1R Agonist Therapy in Subjects With Spinal Cord Injury and Type 2 Diabetes
Led by Marzieh Salehi · Updated on 2026-04-13
50
Participants Needed
2
Research Sites
202 weeks
Total Duration
On this page
Sponsors
M
Marzieh Salehi
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Glycemic and Weight Loss Effects of GLP-1R Agonist Therapy in Subjects With Spinal Cord Injury and Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects aged 18-70 years at screening
- More than one year after spinal cord injury
- Injury levels C2-L2 with Asia Impairment Scale A, B, C, or D
- Signed written informed consent before any study procedures
- Diagnosed with type 2 diabetes managed with diet and metformin monotherapy without significant dose changes in the last 3 months
- HbA1c between 6.0% and 9.0% at screening
- Body mass index (BMI) greater than 22 kg/m2 at screening
- Female subjects of childbearing potential must have negative pregnancy tests at screening and randomization and must not be lactating
- Sexually active females with non-sterilized male partners must use a highly effective contraception method during the study and agree to continue it until study end
You will not qualify if you...
- Any condition or history that may interfere with study evaluation or participant safety, or inability/unwillingness to follow study procedures
- Use of another investigational product within 30 days or 5 half-lives before screening
- Use of mirabegron or other glucose-altering medications
- Use of steroids within the past year
- Significant anemia with hemoglobin less than 11 g/dL
- History of gastric outlet obstruction or chronic diarrhea
- Chronic neurological illnesses other than spinal cord injury
- Use of weight control drugs or certain diabetes medications within specified time frames before the study
- Severe allergy or hypersensitivity to study treatments or acetaminophen
- Symptoms of uncontrolled blood glucose or history of type 1 diabetes or diabetic ketoacidosis
- Significant inflammatory bowel disease or severe upper gastrointestinal disease or surgery affecting safety evaluation
- Acute or chronic pancreatitis
- Significant liver disease or abnormal liver function tests
- Impaired kidney function with estimated glomerular filtration rate less than 45 mL/min/1.73m2
- Recent serious heart conditions or procedures within the last 3 to 6 months
- Severe congestive heart failure (NYHA Class III or IV)
- High basal calcitonin levels or personal/family history of certain thyroid cancers
- History of cancer within 5 years except certain skin or cervical cancers
- History of HIV infection, immune compromise, or organ transplantation
- Substance dependence or history of alcohol abuse
- Following a ketogenic diet
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University Health - Texas Diabetic Institute
San Antonio, Texas, United States, 78207
Actively Recruiting
2
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
M
Marzieh Salehi, MD
CONTACT
A
Andrea Hansis-Diarte, MPh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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