NCT06131372

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

Completed Phase 2 Last updated 1 April 2026

What this trial tests

Phase 2 trial testing Cagrilintide in Chronic Kidney Disease in 626 participants. Completed in 6 November 2025.

Timeline

1 April 2024

Primary endpoint
24 September 2025

6 November 2025

Quick facts

Lead sponsor	Novo Nordisk A/S
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	626
Start date	1 April 2024
Primary completion	24 September 2025
Estimated completion	6 November 2025
Sites	128 locations across United States, Thailand, Japan, Slovakia, Brazil, France, India, Hungary

Drugs / interventions tested

• Cagrilintide — full drug profile →
• Semaglutide (semaglutide) — full drug profile →
• Placebo

Conditions studied

• Chronic Kidney Disease — all drugs for Chronic Kidney Disease →
• Type 2 Diabetes — all drugs for Type 2 Diabetes →
• Obesity — all drugs for Obesity →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

18 and older, any sex, with Chronic Kidney Disease or Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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. The study will compare CagriSema to the 2 medicines semaglutide and cagrilintide, when they are taken alone. It will also compare CagriSema to a "dummy" medicine (also called placebo) without any active ingredient. Participant will either get CagriSema, semaglutide, cagrilintide or placebo. Which treatment participant will get is decided by chance (like flipping a coin). Study doctor will not know which of the study medicines participant will get. For each participant, the study will last for about 35 weeks.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. GLP-1 receptor agonists in patients with chronic kidney disease and either overweight or obesity.
   Abasheva D, Ortiz A, Fernandez-Fernandez B. · · 2024 · cited 27× · PMID 39583142 · DOI 10.1093/ckj/sfae296
2. Amylin, Another Important Neuroendocrine Hormone for the Treatment of Diabesity.
   Eržen S, Tonin G, Jurišić Eržen D, Klen J. · · 2024 · cited 23× · PMID 38338796 · DOI 10.3390/ijms25031517
3. Hippocampal Leptin Resistance and Cognitive Decline: Mechanisms, Therapeutic Strategies and Clinical Implications.
   Valladolid-Acebes I. · · 2024 · cited 9× · PMID 39594988 · DOI 10.3390/biomedicines12112422
4. Obesity-Related Glomerulosclerosis-How Adiposity Damages the Kidneys.
   Zbrzeźniak-Suszczewicz J, Winiarska A, Perkowska-Ptasińska A, Stompór T. · · 2025 · cited 8× · PMID 40650024 · DOI 10.3390/ijms26136247
5. Are we ready for an adipocentric approach in people living with type 2 diabetes and chronic kidney disease?
   Moreno-Pérez O, Reyes-García R, Modrego-Pardo I, López-Martínez M, et al · · 2024 · cited 8× · PMID 38572499 · DOI 10.1093/ckj/sfae039
6. New pharmacological agents and novel cardiovascular pharmacotherapy strategies in 2024.
   Tamargo J, Agewall S, Ambrosio G, Borghi C, et al · · 2025 · cited 6× · PMID 40058879 · DOI 10.1093/ehjcvp/pvaf012
7. An Overview of Existing and Emerging Weight-Loss Drugs to Target Obesity-Related Complications: Insights from Clinical Trials.
   Kim MK, Kim HS. · · 2025 · cited 4× · PMID 39696983 · DOI 10.4062/biomolther.2024.228
8. Diabetes and its complications: molecular mechanisms, prevention and treatment.
   Zhao L, Yuan J, Yang Q, Ma J, et al · · 2026 · cited 2× · PMID 41549124 · DOI 10.1038/s41392-025-02401-w