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Trial · Interventional

CompletedPhase 2Registry data

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

NCTNCT06131372 (opens ClinicalTrials.gov in a new tab)Other idNN9388-7700Other idU1111-1291-5907Other id2023-505857-42Other id2023

Overview

Status
Completed
Phase
Phase 2
Enrollment
626 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
13 countries

United States, Argentina, Brazil, Canada, France, Greece, Hungary, India, Japan, Poland, Slovakia, Spain, Thailand

Start
1 Apr 2024
Primary completion
24 Sept 2025
Completion
6 Nov 2025
First posted
14 Nov 2023
Last update posted
24 Sept 2026
Conditions
Chronic Kidney Disease · Type 2 Diabetes · Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026
  1. Ph 2

    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

    NCT06131372

    1 Apr 2024 to 6 Nov 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • CagrilintideDrug
  • SemaglutideDrug
  • PlaceboDrug

Arms4

  • 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 outcomes1

Outcomes the sponsor listed as primary.

  1. Change in urinary albumin-to-creatinine ratio (UACR)

    Time frame · From baseline (week 0) to end of treatment (week 26)

    Registry description

    Measured in ratio to baseline.

Secondary outcomes(13)
  1. Change in estimated glomerular filtration rate (eGFR) (creatinine and cystatin C-based chronic kidney disease (CKD)-Epidemiology Collaboration equation (EPI) 2021)

    Time frame · From baseline (week 0) to end of treatment (week 26)

    Registry description

    Measured in milliliters per minute per 1.73 meters square (mL/min/1.73 m\^2).

  2. Change in eGFR (creatinine-based CKD-EPI 2021)

    Time frame · From baseline (week 0) to end of treatment (week 26)

    Registry description

    Measured in mL/min/1.73 m\^2.

  3. Relative change in body weight

    Time frame · From baseline (week 0) to end of treatment (week 26)

    Registry description

    Measured in percentage (%).

  4. Achievement of greater than or equal to (≥) 5 % weight reduction

    Time frame · From baseline (week 0) to end of treatment (week 26)

    Registry description

    Count of participants.

  5. Achievement of ≥ 10 % weight reduction

    Time frame · From baseline (week 0) to end of treatment (week 26)

    Registry description

    Count of participants.

  6. Change in waist circumference

    Time frame · From baseline (week 0) to end of treatment (week 26)

    Registry description

    Measured in centimeter (cm).

  7. Change in glycated haemoglobin (HbA1c)

    Time frame · From baseline (week 0) to end of treatment (week 26)

    Registry description

    Measured in %-points.

  8. Change in systolic blood pressure

    Time frame · From baseline (week 0) to end of treatment (week 26)

    Registry description

    Measured in millimeters of mercury (mmHg).

  9. Change in diastolic blood pressure

    Time frame · From baseline (week 0) to end of treatment (week 26)

    Registry description

    Measured in mmHg.

  10. Number of treatment emergent adverse events (TEAEs)

    Time frame · From baseline (week 0) to end of study (week 32)

    Registry description

    count of events.

  11. Number of treatment emergent serious adverse events (SAEs)

    Time frame · From baseline (week 0) to end of study (week 32)

    Registry description

    count of events.

  12. Number of clinically significant hypoglycaemic episodes (level 2) ( blood glucose less than [<] 3.0 millimoles per liter [mmol/L] (54 milligram per deciliter [mg/dL]))

    Time frame · From baseline (week 0) to end of study (week 32)

    Registry description

    Count of episodes.

  13. Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold

    Time frame · From baseline (week 0) to end of study (week 32)

    Registry description

    Count of episodes.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male or female. * Age 18 years or above at the time of signing the informed consent. * Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening. * Body mass index (BMI) ≥ 27.0 kilograms per meter square (kg/m\^2) at screening. BMI will be calculated in the eCRF (electronic case report form) based on height and body weight at screening. * HbA1c less than or equal to (≤) 10.5% (91 millimoles per mole \[mmol/mol\]) as assessed by central laboratory at screening. * Kidney impairment defined by serum creatinine and cystatin C-based eGFR ≥ 15 and \< 90 milliliters per minutes per 1.73\^m\^2 (mL/min/1.73 m\^2) (CKD-EPI 2021) as assessed by central laboratory at screening. * Albuminuria defined by UACR ≥ 100 and \< 5000 milligram per gram (mg/g) as assessed by central laboratory at screening. * Treatment with maximum labelled or tolerated dose of an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated, in the opinion of the investigator. Treatment dose must be stable for at least 30 days prior to screening. Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method. * 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. * Chronic or intermittent haemodialysis or peritoneal dialysis within 90 days before screening. * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. * Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in-situ carcinomas of the cervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia (PIN) within 5 years before screening.

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