← Back to Search

GLP-1R Agonist

Semaglutide for Type 2 Diabetes and Spinal Cord Injury

Phase 4

Recruiting

Led By Marzieh Salehi, MD

Research Sponsored by Marzieh Salehi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Levels of injury C2-L2 with Asia Impairment Scale A, B, C, or D

Must not have

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])

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 24 weeks

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

"This trial will investigate whether a new diabetes drug, semaglutide, is effective in treating type 2 diabetes in individuals with spinal cord injury. The study will focus on how semaglutide

Who is the study for?

This trial is for adults aged 18-70 with spinal cord injury (C2-L2, Asia Impairment Scale A-D), type 2 diabetes managed with diet/metformin, and a BMI over 22. They must be at least one year post-injury and not on certain medications or have conditions like severe allergies, significant anemia, liver disease, recent heart issues, or history of cancer within the last five years.

What is being tested?

The study tests semaglutide's effectiveness in controlling blood sugar levels in those with spinal cord injuries who also have type 2 diabetes. Participants will either receive semaglutide injections or a placebo to compare outcomes related to glucose control and weight loss.

What are the potential side effects?

Semaglutide may cause digestive issues such as nausea or diarrhea, potential risk of pancreatitis, changes in appetite leading to weight loss. It can also affect blood sugar levels which might require monitoring during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 70 years old.

Select...

My spinal cord injury is between C2 and L2 and is classified as A, B, C, or D.

Select...

I am not pregnant, not breastfeeding, and have a negative pregnancy test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My kidney function is low, with an eGFR below 45 mL/min.

Select...

My liver is mostly healthy and my liver tests are not too high.

Select...

My calcitonin levels are above 50 ng/L, or I have a personal or family history of thyroid cancer.

Select...

I do not have severe bowel issues or major GI surgery that could affect study results.

Select...

I have type 1 diabetes or have had very high or low blood sugar recently.

Select...

I have severe heart failure.

Select...

I am taking medication that affects my blood sugar levels.

Select...

I have taken steroids in the last year.

Select...

I have had issues with blocked stomach exits or ongoing diarrhea.

Select...

I have a chronic neurological condition other than spinal cord injury.

Select...

I have had pancreatitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Glucose tolerance

Insulin sensitivity

Side effects data

From 2018 Phase 3 trial • 458 Patients • NCT03015220

26%

Nasopharyngitis

Constipation

Influenza

Diabetic retinopathy

Nausea

Gastrooesophageal reflux disease

Back pain

Upper respiratory tract inflammation

Abdominal discomfort

Vomiting

Diarrhoea

Cardiac ablation

Herpes zoster

Ischaemic cerebral infarction

Acute myocardial infarction

Appendicitis

Large intestine polyp

Peritonitis

Sudden hearing loss

Rectal adenocarcinoma

Spinal operation

100%

80%

60%

40%

20%

Study treatment Arm

Oral Semaglutide 3 mg

Oral Semaglutide 7 mg

Oral Semaglutide 14 mg

Dulaglutide 0.75 mg

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SCI and T2DM Treatment GroupExperimental Treatment1 Intervention

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.

Group II: SCI and T2DM Placebo GroupPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Semaglutide Injectable Product

2024

Completed Phase 2

~120

0 / 14Eligibility criteria met