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NCT03292315 · ClinicalTrials.gov registry record · Phase 4
Once Weekly GLP-1 in Persons With Spinal Cord Injury
A Phase 4 study, sponsored by James J. Peters Veterans Affairs Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 5
- Enrollment target
NCT03292315: Completed Phase 4 study, sponsored by James J. Peters Veterans Affairs Medical Center.
NCT03292315 is a Phase 4 study that has completed, run by James J. Peters Veterans Affairs Medical Center. The registered enrollment target is 5 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03292315, a Phase 4 study, has completed, sponsored by James J. Peters Veterans Affairs Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 5 participants
- Enrollment target
Study Summary
Chronic spinal cord injury (SCI) results in adverse soft tissue body composition changes and an extremely sedentary lifestyle. These abrupt changes often lead to a high prevalence of cardiometabolic diseases, such as impaired glucose tolerance/diabetes mellitus and dyslipidemia, conditions which predispose those with SCI to an increased risk for cardiovascular disease compared to the general population. Due to paralysis and wheel chair dependence, maintaining an adequate level of physical activity to counteract these deleterious metabolic changes presents a unique obstacle because conventional first line interventions are lifestyle modifications (e.g., diet and exercise), which may be difficult to achieve. Recently, a new medication has been approved by the Food and Drug Administration to improve glycemic control in individuals with diabetes mellitus, and it has also been investigated as an off-label treatment to induce weight loss. Glucagon-like peptide-1 (GLP-1) agonists are a class of drugs designed to mimic the endogenous incretin hormones released from the gut in a glucose dependent manner following a meal. The mechanisms of action for this drug class of medications include stimulation of glucose-dependent insulin secretion, inhibiting glucagon release, slowed gastric emptying, and reduction of postprandial glucose excursions following food intake. In addition to improved glycemic control, this class of medications also shows promise for its non-glycemic action of facilitating weight loss. The method of delivery of the GLP-1's is by self-administered injections once daily or once weekly, depending on the severity of the clinical case and therapeutic targets for a specific patient.
Primary Outcome
Efficacy of GLP-1 to reduce total body weight determined by Dual Energy Absorptiometry (DXA)
Interventions
- OTHER No Intervention
- DRUG Semaglutide 1MG Injection [Ozempic]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2018-10-16 |
| Est. Completion | 2023-03-01 |
| Phase | Phase 4 |
What the finished NCT03292315 record still lists
NCT03292315 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which No Intervention is the first listed.
NCT03292315 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03292315 about?
NCT03292315 is a clinical study titled "Once Weekly GLP-1 in Persons With Spinal Cord Injury". Chronic spinal cord injury (SCI) results in adverse soft tissue body composition changes and an extremely sedentary lifestyle. These abrupt changes often lead to a high prevalence of cardiometabolic diseases, such as impaired glucose tolerance/diabetes mellitus and dyslipidemia, conditions which pre...
What is the current status of trial NCT03292315?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 5 participants. The study started on 2018-10-16. Estimated completion is 2023-03-01.
What interventions are being tested in trial NCT03292315?
The interventions under investigation include: No Intervention (OTHER), Semaglutide 1MG Injection [Ozempic] (DRUG).
Who is sponsoring clinical trial NCT03292315?
This trial is sponsored by James J. Peters Veterans Affairs Medical Center, which has 39 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03292315's enrollment target sits among peer trials
5 1989th of 2000 higher than 7 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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