Trial · Interventional
RecruitingPhase 4Registry dataGlycemic and Weight Loss Effects of GLP-1R Agonist Therapy in Subjects With Spinal Cord Injury and Type 2 Diabetes
Overview
- Status
- Recruiting
- Phase
- Phase 4
- Enrollment
- 50 participants (estimated)
- Sponsor
- Marzieh Salehi · Other
- Design
- Not randomized · Single masking
- Countries
1 country
United States
- Start
- 11 Apr 2025
- Primary completion
- 1 Sept 2028 (estimated)
- Completion
- 1 Mar 2029 (estimated)
- First posted
- 26 Nov 2024
- Last update posted
- 5 Oct 2026
- Conditions
- Spinal Cord Injuries · Type 2 Diabetes
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Glycemic and Weight Loss Effects of GLP-1R Agonist Therapy in Subjects With Spinal Cord Injury and Type 2 Diabetes
NCT0670628411 Apr 2025 to est. 1 Mar 2029
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Semaglutide Injectable ProductDrug
- PlaceboOther
Arms2
Experimental
SCI and T2DM Treatment Group
Participants with spinal cord injury (SCI) and type 2 diabetes (T2DM) will be assigned to semaglutide weekly for 24 weeks. Semaglutide administration: once-weekly self-administration of SGT, titrated to a dose of 2 mg/week as per FDA approved guidelines. All subjects will be instructed how to inject and titrate up the dose.
Placebo comparator
SCI and T2DM Placebo Group
Participants with spinal cord injury (SCI) and type 2 diabetes (T2DM) will be assigned to the placebo group and inject normal saline weekly for 24 weeks. All subjects in the placebo group will be instructed how to inject and titrate up the dose to mimic the semaglutide administration to a maximum dose of 2 mg in 12 weeks and then continue for remainder of study.
Primary outcomes2
Outcomes the sponsor listed as primary.
Glucose tolerance
Time frame · Baseline to 24 weeks
Registry description
The change in the incremental AUC Glucose3h response to meal ingestion
Insulin action
Time frame · Baseline to 24 weeks
Registry description
Liver, adipose tissue and muscle insulin sensitivity determined using a two-step euglycemic clamp.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 70 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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