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Trial · Interventional

RecruitingPhase 4Registry data

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

NCTNCT06706284 (opens ClinicalTrials.gov in a new tab)Other idSTUDY00000591Other idR01DK140144-02

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
202520262027202820292030
  1. Ph 4

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

    NCT06706284

    11 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.

  1. Glucose tolerance

    Time frame · Baseline to 24 weeks

    Registry description

    The change in the incremental AUC Glucose3h response to meal ingestion

  2. 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
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

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