Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 2
Novo Nordisk A/S (Voir sur ClinicalTrials)
avril 2024
décembre 2025
03 octobre 2024
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 2.4 mg, semaglutide 2.4 mg,
cagrilintide 2.4 mg 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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GH PARIS SITE SAINT JOSEPH | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre de Recherche Clinique Portes Du Sud - 69200 - Venissieux - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1 - 44800 - Saint Herblain - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Poitiers - 86000 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1 - 31059 - Toulouse Cedex 9 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Reims-Hopital Maison Blanche - 51092 - Reims cedex - France | Contact (sur clinicalTrials) | ||||
| Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu-1 - 71200 - Le Creusot - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
- 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.
- 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 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.