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New treatment option for Spinal Cord Injuries
Official title Glycemic and Weight Loss Effects of GLP-1R Agonist Therapy in Subjects With Spinal Cord Injury and Type 2 Diabetes
ClinicalTrials.gov ID: NCT06706284
What this study is testing
What is Semaglutide Injectable Product?
Semaglutide Injectable Product is an investigational medicine, given as an once-weekly injectable medicine, being studied as a potential treatment for spinal cord injuries.
Also referred to as Ozempic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Male and female people aged 18-70 years (inclusive) at screening
- More than one year after spinal cord injury
- Levels if injury C2-L2 with Asia Impairment Scale A, B, C or D.
- Provision of signed and dated written informed consent prior to any study specific procedures
- Diagnosed with T2DM with glucose control managed with diet and metformin monotherapy where no significant dose changes (increase or decrease ≥ 50%)...
You likely can't join if
- History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, put...
- 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...
- Taking mirabegron or other glucose altering medications
- Taking steroids within the past 1 year
- Significant anemia (hemoglobin\<11g/dL)
- History of gastric outlet obstruction or chronic diarrhea
See the full eligibility criteria
- Male and female people aged 18-70 years (inclusive) at screening
- More than one year after spinal cord injury
- Levels if injury C2-L2 with Asia Impairment Scale A, B, C or D.
- Provision of signed and dated written informed consent prior to any study specific procedures
- 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
- HbA1c 6.0-9.0% at screening
- BMI \> 22 kg/m2 at screening
- Female people of childbearing potential must have a negative pregnancy test at screening and randomization, and must not be lactating
- 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...
- 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...
- 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
- Taking mirabegron or other glucose altering medications
- Taking steroids within the past 1 year
- Significant anemia (hemoglobin\<11g/dL)
- History of gastric outlet obstruction or chronic diarrhea
- History of a chronic neurological illness other than SCI (i.e.; MS, etc)
- 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
- Severe allergy/hypersensitivity to any of the proposed study treatments, excipients, acetaminophen
- 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...
- 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 side effects...
- Acute or chronic pancreatitis
- 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...
- 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...
- Unstable angina pectoris, myocardial infarction, transient ischemic attack (TIA) or stroke within 3 months prior to screening, or people who have undergone percutaneous coronary intervention or a coronary artery bypass...
- Severe congestive heart failure (New York Heart Association Class III or IV)
- Basal calcitonin level \> 50 ng/L at screening or history/family history of medullary thyroid carcinoma or multiple endocrine neoplasia
- 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
- History of HIV infection or other immune compromised disease; and history of organ transplantation
- Substance dependence or history of alcohol abuse and/or excess alcohol intake
- Patients on ketogenic diet
The study team makes the final eligibility decision.
Where it's taking place
- San Antonio, Texas, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.