SeMaglutide and Albuminuria Reduction Trial in Obese Individuals Without Diabetes

What Was Tested

The trial (phase 3) is built around Semaglutide.

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

Patients will receive a matching placebo s.c. once weekly.

The registry classes the interventions as drug.

More on the Plan

Glucagon Like Peptide 1 Receptor Agonist (GLP1-RA) therapies have been introduced as antidiabetic drugs.

It is therefore likely that these agents delay progression of kidney function decline in high risk obese/overweight, non-diabetic individuals.

This will be tested in a 24-week randomized placebo controlled double-blind two arm parallel clinical trial with a 4 week wash-out period after 24 weeks double blind treatment to assess off drug effects.

Who Took Part

125 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. Body Mass index ≥ 27 kg/m2. Signed Informed Consent.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: diagnosis with type 1 or type 2 diabetes; cardiovascular disease event in 3 months prior to enrollment; treatment with glp-1 ra \< 4 weeks prior to screening.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

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 2022-03-14 with completion listed for 2024-05-28.

It ran at 13 sites in Netherlands (5), Spain (4), Canada (2) and Germany (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change from baseline to week 24 in urinary albumin:creatinine ratio (UACR) (time frame: Week 1 to week 24).

It also tracked 9 secondary outcomes, for example estimated glomerular filtration rate (eGFR), Iohexol measured glomerular filtration rate (GFR), urinary albumin:creatinine ratio (UACR) during wash-out, estimated glomerular filtration rate (eGFR) during wash-out, body weight and hip circumference.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 125 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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