DRUG
Cagrilintide
Participants will receive Cagrilintide subcutaneously.
Status
Completed
Phase
Phase 2
Enrollment
626
Locations
128
Results
Not posted
Publications
0
Study summary
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
DRUG
Participants will receive Cagrilintide subcutaneously.
DRUG
Participants will receive semaglutide subcutaneously.
DRUG
Participants will receive placebo matched to cagrilintide or placebo matched to semaglutide subcutaneously.
Timeline
First posted
Nov 14, 2023
Study start
Apr 1, 2024
Primary completion
Sep 24, 2025
Study completion
Nov 6, 2025
Results posted
Not reported
Registry updated
Apr 1, 2026
Outcomes
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.
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).
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.
Relative change in body weight
Time frame · From baseline (week 0) to end of treatment (week 26)
Measured in percentage (%).
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.
Achievement of ≥ 10 % weight reduction
Time frame · From baseline (week 0) to end of treatment (week 26)
Count of participants.
Change in waist circumference
Time frame · From baseline (week 0) to end of treatment (week 26)
Measured in centimeter (cm).
Change in glycated haemoglobin (HbA1c)
Time frame · From baseline (week 0) to end of treatment (week 26)
Measured in %-points.
Change in systolic blood pressure
Time frame · From baseline (week 0) to end of treatment (week 26)
Measured in millimeters of mercury (mmHg).
Change in diastolic blood pressure
Time frame · From baseline (week 0) to end of treatment (week 26)
Measured in mmHg.
Number of treatment emergent adverse events (TEAEs)
Time frame · From baseline (week 0) to end of study (week 32)
count of events.
Eligibility
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.
Study locations
Argentina · Brazil · Canada · France · Greece · Hungary · India · Japan · Poland · Slovakia · Spain · Thailand · United States. Showing up to 24 locations stored in the fast local snapshot.
John Muir Physicians Network
Concord, California, United States
Valley Research
Fresno, California, United States
Desert Oasis Hlthcr Med Group
Palm Springs, California, United States
North America Research Institute
San Dimas, California, United States
NorCal Endocrinology and Internal Medicine
San Ramon, California, United States
Northeast Research Institute
Fleming Island, Florida, United States
Life Spring Research Foundation LLC
Miami, Florida, United States
Advent Health Translational Research Institute
Orlando, Florida, United States
Velocity Clin. Res Valparaiso
Valparaiso, Indiana, United States
Elite Research Center
Flint, Michigan, United States
Univ. of Nebraska Medical Center_Omaha
Omaha, Nebraska, United States
Albany Medical College
Albany, New York, United States
NYU Langone Nephrology Associates
Mineola, New York, United States
New York University Grossman School of Medicine
New York, New York, United States
Southgate Medical Group, LLP
West Seneca, New York, United States
Carteret Medical Group
Morehead City, North Carolina, United States
Eastern Nephrology Associates, PLLC
New Bern, North Carolina, United States
Brookview Hills Research Associates, LLC
Winston-Salem, North Carolina, United States
Ohio- Advanced Medical Research
Maumee, Ohio, United States
Heritage Valley Multispeciality Group Inc
Beaver, Pennsylvania, United States
Main Street Physician's Care
Little River, South Carolina, United States
Osvaldo A. Brusco MD
Corpus Christi, Texas, United States
Southwest Houston Research Ltd
Houston, Texas, United States
Clinical Advancement Center
San Antonio, Texas, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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