Effect of Subcutaneous Semaglutide on Kidney Transplant Candidacy

What Was Tested

This registered phase 3 trial tested Semaglutide.

This randomized study evaluates the effect of subcutaneous semaglutide /in combination with lifestyle counseling in patients with type 2 diabetes mellitus (T2DM), overweight/obesity, and stage 4-5 chronic kidney disease (CKD) or dialysis-dependent end-stage kidney disease (ESKD) on patients' eligibility for kidney transplantation at the end of 9 months.

It had two arms (groups): Semaglutide (active comparator) and Placebo (placebo comparator).

This arm will receive semaglutide.

This arm will receive placebo.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 15 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: \- Age ≥ 18 years. \- BMI 25-45 kg/m2.

The full record lists 5 inclusion and 31 exclusion criteria; among the exclusions: \- ability to provide informed consent before any trial-related activities; \- access to a telephone; the cause of the ckd does not need to be due specifically to diabetes.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

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

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2021-07-23 with completion listed for 2023-01-31.

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

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Kidney Transplant Eligibility (time frame: Ascertained at the end of 9 months).

It also tracked 7 secondary outcomes, for example Change in Hemoglobin A1c (HgbA1c), Change in BMI, Change in Waist Circumference, Change in Waist-to-hip Ratio, Change in Body Fat Percentage and New Activation on the Transplant List.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 15 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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