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OpenTrials
Completed

NCT Number: 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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

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

    Measured in ratio to baseline.

Secondary outcomes

  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)

    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)

    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)

    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)

    Count of participants.

  5. Achievement of ≥ 10 % weight reduction

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

    Count of participants.

  6. Change in waist circumference

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

    Measured in centimeter (cm).

  7. Change in glycated haemoglobin (HbA1c)

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

    Measured in %-points.

  8. Change in systolic blood pressure

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

    Measured in millimeters of mercury (mmHg).

  9. Change in diastolic blood pressure

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

    Measured in mmHg.

  10. Number of treatment emergent adverse events (TEAEs)

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

    count of events.

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

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

    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)

    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)

    Count of episodes.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema 2.4 mg/2.4 mg) Once Weekly Versus Semaglutide 2.4 mg, Cagrilintide 2.4 mg and Placebo in People With Chronic Kidney Disease and Type 2 Diabetes Living With Overweight or Obesity

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 14, 2023
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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