A Research Study to See if Kidney Damage in People With Chronic Kidney Disease and Type 2 Diabetes Living With Overweight or Obesity Can be Reduced by CagriSema Compared to Semaglutide, Cagrilintide and Placebo

What Was Tested

This registered phase 2 trial tested Cagrilintide and Semaglutide.

This study will look if CagriSema can lower kidney damage in people with chronic kidney disease (CKD), type 2 diabetes (T2D) and overweight or obesity.

CagriSema is a new investigational medicine.

CagriSema cannot yet be prescribed by doctors.

It had four arms (groups): CagriSema (experimental), Semaglutide (experimental), Cagrilintide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 626 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.

The full record lists 8 inclusion and 7 exclusion criteria; among the exclusions: congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations; use of any glucagon-like peptide-1 receptor agonist (glp-1ra) (including medication with glp-1ra activity, e.g., gip/glp-1ra) or amylin analogue within 60 days prior to screening; myocardial infarction, stroke, transient ischaemic attack, or hospitalization for unstable angina pectoris within 60 days before screening.

How the Study Was Run

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

Because people in this Cagrilintide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Blinding on both sides kept the participants and researchers unaware of who received Cagrilintide.

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

It started in 2024-04-01 with completion listed for 2025-09-24.

It ran at 129 sites in United States (25), Greece (20), Poland (13), Japan (10), Canada (9) and India (9).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in urinary albumin-to-creatinine ratio (UACR) (time frame: From baseline (week 0) to end of treatment (week 26)).

It also tracked 13 secondary outcomes, for example Change in eGFR (creatinine-based CKD-EPI 2021), Relative change in body weight, Change in waist circumference, Change in glycated haemoglobin (HbA1c), Change in systolic blood pressure and Change in diastolic blood pressure.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Cagrilintide and Semaglutide in 626 people.

With 626 participants it is a large trial for this field.

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

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