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

What Was Tested

This registered phase 4 trial tested Semaglutide.

It had two arms (groups): SCI and T2DM Treatment Group (experimental) and SCI and T2DM Placebo Group (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

This study consists of 7-9 in-person visits and 9-10 phone visits, and participants will be randomized to either semaglutide or placebo for 24 weeks.

The participants first visit, will include review of medical history and performance of standard tests to check the participant's health and eligibility for the study.

Before starting any medication, participants will have 2 more visits: * a mixed meal tolerance test, to examine their body's response to nutrient ingestion and * a glucose clamp study to examine insulin sensitivity.

These tests will be scheduled on two separate days.

Who Took Part

The registry lists 50 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male and female subjects 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. BMI \> 22 kg/m2 at screening.

The full record lists 9 inclusion and 23 exclusion criteria; among the exclusions: taking mirabegron or other glucose altering medications; taking steroids within the past 1 year; history of gastric outlet obstruction or chronic diarrhea.

How the Study Was Run

The set-up was non-randomized, parallel-group and single-blind.

The Semaglutide group and the comparison group ran side by side rather than switching.

In this single-blind Semaglutide study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2025-04-11 with completion listed for 2028-09-01.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Glucose tolerance (time frame: Baseline to 24 weeks). Insulin action (time frame: Baseline to 24 weeks).

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Semaglutide in 50 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.