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Delfa

← All trials/NCT03292315

CompletedPhase 4

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

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 WeightHOMA-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

NCT IDNCT03292315
Org study IDBAU-17-038

Timeline

Milestones

Study first posted2017-09-25actual
Study start2018-10-16actual
Primary completion2020-03-01actual
Study completion2023-03-01actual
Last update posted2023-03-14actual

Assets

Investigational agents

Who this study enrolls

Obesity / overweightPrediabetes / glucose intoleranceSpinal Cord Injuries

Who can enroll

Minimum age18 Years
Maximum age69 Years
SexAll
Healthy volunteersNot accepted

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

Glycemic / diabetes
3
Weight & body composition
2

Weight & body composition

2 endpoints
Primary/protocol endpoint

Body Weight

Time frame:Baseline, Week 13, Week 26

change from baseline, improvement

Secondary/protocol endpoint

Body Fat

Time frame:Baseline, Week 13, Week 26

Total fat mass

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Primary/protocol endpoint

Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

Time frame:Baseline, Week 13, Week 26

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Primary/protocol endpoint

Homeostatic Model Assessment of Beta-Cell Function (HOMA-B)

Time frame:Baseline, Week 13, Week 26

change from baseline, improvement

Secondary/protocol endpoint

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.