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cagrilintide amylin agonist rct n=626 2024-04-01 ClinicalTrials

CagriSema Combination Drug to Be Tested for Kidney Protection in Diabetes

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

Background

Chronic Kidney Disease (CKD) and Type 2 Diabetes often co-exist, leading to severe health complications, particularly in individuals living with overweight or obesity. While existing treatments like semaglutide improve glycemic control and weight, their specific efficacy in directly reducing kidney damage in this high-risk population, especially when combined with other agents, remains to be fully elucidated. This study aims to determine if the novel combination of cagrilintide and semaglutide (CagriSema) can more effectively reduce kidney damage compared to individual components or placebo.

Study Design

Population
N=626 patients with Type 2 Diabetes, obesity, and Chronic Kidney Disease.
Intervention
CagriSema (co-administered cagrilintide 2.4 mg and semaglutide 2.4 mg), dose and route not specified, duration ongoing until November 2025.
Comparator
semaglutide 2.4 mg, cagrilintide 2.4 mg, and placebo.
Outcome
The primary outcome is to assess the superior efficacy in reducing kidney damage and improved safety profiles.

Results

As this is a completed design abstract for a Phase 2 study, the actual efficacy and safety results are not yet available, but the study's primary objective is clearly defined. The trial has successfully enrolled 626 participants, indicating a robust sample size for a Phase 2 investigation into this novel combination therapy. The study is designed to assess whether CagriSema (co-administered cagrilintide 2.4 mg and semaglutide 2.4 mg) demonstrates superior efficacy in reducing kidney damage and improved safety profiles compared to semaglutide 2.4 mg, cagrilintide 2.4 mg, and placebo. The study aims to quantitatively compare changes in kidney function markers and safety endpoints across the four treatment arms, with data collection ongoing until November 2025. This design will provide crucial insights into the comparative benefits of the combination versus monotherapies.

Why It Matters

If CagriSema proves effective, it could represent a significant advancement in managing Chronic Kidney Disease in patients with Type 2 Diabetes and obesity, a population with high unmet medical needs. The potential for a single combination therapy to address multiple facets of these interconnected conditions—glycemic control, weight management, and direct kidney protection—is substantial. Successful outcomes from this Phase 2 study could pave the way for larger Phase 3 human trials, potentially leading to a new therapeutic option for millions worldwide. This research is critical for developing more comprehensive treatment strategies beyond current standards of care.


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Source: clinicaltrials:NCT06131372 · Ingested 2026-04-24 · Digest: gemini-2.5-flash