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RecruitingPhase 4

Glycemic and Weight Loss Effects of GLP-1R Agonist Therapy in Subjects With Spinal Cord Injury and Type 2 Diabetes

Lead sponsor

Marzieh Salehi

Asset

Semaglutide

GLP-1 agonist

Listed sites

2

Recruiting sites

2

Enrollment

50

estimated

Study population

Spinal Cord Injuries, Type 2 diabetes

Key I/E criteria

BMI ≥22HbA1c 6-9%

Primary endpoints

Postprandial glucoseInsulin action

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06706284
Org study IDSTUDY00000591
Secondary IDR01DK140144-02

Timeline

Milestones

Study first posted2024-11-26actual
Study start2025-04-11actual
Last update posted2026-04-13actual
Primary completion2028-09-01estimated
Study completion2029-03-01estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Spinal Cord InjuriesType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Male and female subjects aged 18-70 years (inclusive) at screening

2. More than one year after spinal cord injury

3. Levels if injury C2-L2 with Asia Impairment Scale A, B, C or D.

4. Provision of signed and dated written informed consent prior to any study specific procedures

5. Diagnosed with T2DM with glucose control managed with diet and metformin monotherapy where no significant dose changes (increase or decrease ≥ 50%) have occurred in the three months prior to screening

6. HbA1c 6.0-9.0% at screening

7. BMI > 22 kg/m2 at screening

8. Female subjects of childbearing potential must have a negative pregnancy test at screening and randomization, and must not be lactating

9. Females of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception from screening and must agree to continue using such precautions through to the end of the study. It is strongly recommended for the male partner of a female subject to also use male condom plus spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.

Exclusion criteria

1. History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, put the subject at risk, influence the subject's ability to participate or affect the interpretation of the results of the study and/or any subject unable or unwilling to follow study procedures.

2. Any subject who has received another investigational product as part of a clinical study within the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening

3. Taking mirabegron or other glucose altering medications

4. Taking steroids within the past 1 year

5. Significant anemia (hemoglobin<11g/dL)

6. History of gastric outlet obstruction or chronic diarrhea

7. History of a chronic neurological illness other than SCI (i.e.; MS, etc)

8. Any subject who has received any of the following medications within the specified time-frame prior to the start of the study

Herbal preparations or drugs licensed for control of body weight or appetite (eg, orlistat, bupropion-naltrexone, phentermine-topiramate, phentermine, lorcaserin) within a year prior to the start of the study
Pioglitazone, SGLT2 or DPPIV inhibitors, GLP-1RA within the last 60 days at the time of screening

9. Severe allergy/hypersensitivity to any of the proposed study treatments, excipients, acetaminophen

10. Symptoms of acutely decompensated blood glucose control (eg, thirst, polyuria, weight loss), a history of type 1 diabetes mellitus (T1DM) or diabetic ketoacidosis, or if the subject has been treated with daily SC insulin within 90 days prior to screening.

11. Significant inflammatory bowel disease or other severe disease or surgery affecting the upper GI tract (including weight-reducing surgery and procedures) which could affect the interpretation of safety and tolerability data. Prior history of bariatric surgery is not considered exclusion given the ample evidence of safety of use of GLP-1R therapy in this population.

12. Acute or chronic pancreatitis

13. Significant hepatic disease (except for metabolic dysfunction-associated steatohepatitis [MASH] or metabolic dysfunction-associated steatotic liver disease [MASLD]) without portal hypertension or cirrhosis) and/or subjects with any of the following results at screening:

Aspartate transaminase (AST) ≥ 3 × upper limit of normal (ULN) Alanine transaminase (ALT) ≥ 3 × ULN Total bilirubin ≥ 2 × ULN

14. Impaired renal function defined as estimated glomerular filtration rate (eGFR) < 45 mL/minute/1.73m2 at screening (GFR estimated according to Modification of Diet in Renal Disease (MDRD) using MDRD Study Equation IDMS-traceable [SI units])

15. Unstable angina pectoris, myocardial infarction, transient ischemic attack (TIA) or stroke within 3 months prior to screening, or subjects who have undergone percutaneous coronary intervention or a coronary artery bypass graft within the past 6 months or who are due to undergo these procedures at the time of screening

16. Severe congestive heart failure (New York Heart Association Class III or IV)

17. Basal calcitonin level > 50 ng/L at screening or history/family history of medullary thyroid carcinoma or multiple endocrine neoplasia

18. History of neoplastic disease within 5 years prior to screening, except for adequately treated basal cell, squamous cell skin cancer, or in situ cervical cancer

19. History of HIV infection or other immune compromised disease; and history of organ transplantation

20. Substance dependence or history of alcohol abuse and/or excess alcohol intake

21. Patients on ketogenic diet

Endpoints (2)

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.

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint

Glucose tolerance

Time frame:Baseline to 24 weeks

Postprandial glucose

change from baseline, improvement

Primary/protocol endpoint

Insulin action

Time frame:Baseline to 24 weeks

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 1, 2026 snapshot.