Once Weekly GLP-1 in Persons With Spinal Cord Injury
The Efficacy of a Once Weekly Glucagon-Like Peptide-1 Agonist on Body Weight/Composition and Metabolic Parameters in Persons With SCI
Lead sponsor
Asset
Semaglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
-
Actual enrollment
5
Study population
Obesity / overweight, Prediabetes / glucose intolerance, Spinal Cord Injuries
Eligibility highlights
•HbA1c 5.7-6.4%
Primary endpoints
•Body Weight•HOMA-IR (insulin sensitivity)•Homeostatic Model Assessment of Beta-Cell Function (HOMA-B)
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
Inclusion criteria
1. Male or female, age 18 to 69;
2. Chronic (e.g., duration of injury greater than 3 years) stable SCI (regardless of level of neurological injury);
3. ASIA A-D (non-ambulatory defined as not able to weight bear for more than 20% of the day);
4. Obese Percent Body Fat defined as > 25% for men and > 35% for women (as determined by screening DXA scan);
5. Insulin Resistant as determined at screening: (FPI, ≥15 µU/ml); -OR-
6. Pre-diabetic, as determined by any one of the following:
1. HbA1C ≥ 5.7% and < 6.4%; or
2. Impaired glucose tolerance by FSG ≥100 mg/dl and < 125 mg/dl and/or the 2 hour serum glucose concentration (after an OGTT) ≥ 140 mg/dl and < 200 mg/dl
Exclusion criteria
1. Personal history of or family history of medullary thyroid carcinoma;
2. History of multiple endocrine neoplasia syndrome type 2;
3. History of pancreatitis;
4. Existing diagnosis of diabetes mellitus, or the results from screening OGTT that identify diabetes mellitus (previously undiagnosed); laboratory thresholds for exclusion will be as follows: HbA1C ≥6.5%, fasting plasma glucose >126 mg/dl, or 2 hour value >200 mg/dl;
5. Receiving treatment for impaired glucose metabolism (i.e., insulin, secretagogues, or other agents to modify peripheral insulin sensitivity or serum glucose concentration);
6. Reduced kidney function (by glomerular filtration rate (GFR <60 ml/min) or liver function tests (any single LFT ≥ 2.5 times above the upper limit of normal) as determined by test results at screening and any time point of the study;
7. Elevated calcitonin level (as determined at screening to rule out thyroid cancer);
8. Pregnancy or women who may become pregnant during the course of the study, or those who are nursing;
9. Medically unstable;
10. Acute illness or infection;
11. Diminished mental capacity; and
12. Inability or unwillingness of subject to provide informed consent.
Endpoints (5)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
2 endpointsBody Weight
Time frame:Baseline, Week 13, Week 26
change from baseline, improvement
Body Fat
Time frame:Baseline, Week 13, Week 26
Total fat mass
change from baseline, improvement
Glycemic / diabetes
3 endpointsHomeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame:Baseline, Week 13, Week 26
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Homeostatic Model Assessment of Beta-Cell Function (HOMA-B)
Time frame:Baseline, Week 13, Week 26
change from baseline, improvement
Glycated Hemoglobin (HbA1C)
Time frame:Baseline, Week 13, Week 26
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- The journal of spinal cord medicine2024 Jul (month)PMID37158751doi:10.1080/10790268.2023.2207064via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.