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.(NN9388-7700)

JRCT ID: jRCT2031230700

Registered date:13/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: chronic kidney disease and type 2 diabetes living with overweight or obesity
• Date of first enrollment: 05/04/2024
• Target sample size: 50
• Countries of recruitment: Argentina,Japan,Brazil,Japan,Canada,Japan,France,Japan,Greece,Japan,Hungary,Japan,India,Japan,Poland,Japan,Slovakia,Japan,Spain,Japan,Thailand,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

This is an interventional, multi-national, multi-centre, randomised, parallel-group study comparing
CagriSema versus semaglutide, cagrilintide and placebo. The study will be double-blinded.
Approximately 618 participants with CKD, T2D and overweight or obesity will be randomised in a
3:3:1:1 manner to receive either:
-CagriSema 2.4 mg/2.4 mg
-Semaglutide 2.4 mg
-Cagrilintide 2.4 mg
-Placebo

All treatments are administered once weekly.
The study consists of:
-up to 3-week screening period
-a 26-week intervention period which includes at least 16-week dose escalation followed by an up to 10-week maintenance period until end-of-treatment
-a 6-week follow-up period
CagriSema, semaglutide, cagrilintide and placebo treatment will follow a dose escalation.
Treatment will be initiated at 0.25 mg/0.25 mg once weekly for 4 weeks, followed by stepwise dose escalation to 0.5 mg/ 0.5 mg, 1.0 mg/1.0 mg, 1.7 mg/1.7 mg, and 2.4 mg/2.4 mg (in 4 weeks intervals). Dose escalation will last for at least 16 weeks, where the target doses will be achieved.
Randomisation will be stratified by SGLT2 inhibitor use at screening (yes or no) and UACR at screening > 300 mg/g (yes or no).

Outcome(s)

Primary Outcome

To investigate whether CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg, cagrilintide 2.4 mg and
placebo improves surrogate markers of CKD progression in participants with T2D

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.
-BMI >= 27.0 kg/m2 at screening. BMI will be calculated in the eCRF based on height and body weight at screening.
-HbA1c <= 10.5% (91 mmol/mol) as assessed by central laboratory at screening.
-Kidney impairment defined by serum creatinine and cystatin C-based eGFR >= 15 and < 90mL/min/1.73 m2 (CKD-EPI 2021) as assessed by central laboratory at screening.
-Albuminuria defined by UACR >=100 and < 5000 mg/ga 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.

Exclude 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 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 a fundus 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.

Related Information

• Primary Sponsor: Ishikawa Wataru
• Secondary ID(s): NCT06131372