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

Conditions

• Chronic Kidney Disease
• Obesity
• Type 2 Diabetes

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cagrilintide — DRUG
  Participants will receive Cagrilintide subcutaneously.
• Semaglutide — DRUG
  Participants will receive semaglutide subcutaneously.
• Placebo — DRUG
  Participants will receive placebo matched to cagrilintide or placebo matched to semaglutide subcutaneously.

Study Details

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.

Key Dates

Start date

Apr 1, 2024

Status verified

Mar 2026

Primary completion

Sep 24, 2025

Completion

Nov 6, 2025

Study Design

Enrollment

626 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CagriSema
  Participants will receive cagrilintide and semaglutide subcutaneously once-weekly after a dose escalation period of 16 weeks during the maintenance period for 10 weeks.
• Experimental: Semaglutide
  Participants will receive semaglutide and placebo matched to cagrilintide subcutaneously once-weekly after a dose escalation period of 16 weeks during the maintenance period for 10 weeks.
• Experimental: Cagrilintide
  Participants will receive cagrilintide and placebo matching to semaglutide subcutaneously once-weekly after a dose escalation period of 16 weeks during the maintenance period for 10 weeks.
• Placebo Comparator: Placebo
  Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide subcutaneously once weekly for 26 weeks.

Primary Outcome Measure

Change in urinary albumin-to-creatinine ratio (UACR) [ Time Frame: From baseline (week 0) to end of treatment (week 26) ]

Locations (25)

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