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
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
3 other identifiers
interventional
626
13 countries
128
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2024
128 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2023
CompletedFirst Posted
Study publicly available on registry
November 14, 2023
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 24, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2025
CompletedApril 1, 2026
March 1, 2026
1.5 years
November 9, 2023
March 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in urinary albumin-to-creatinine ratio (UACR)
Measured in ratio to baseline.
From baseline (week 0) to end of treatment (week 26)
Secondary Outcomes (13)
Change in estimated glomerular filtration rate (eGFR) (creatinine and cystatin C-based chronic kidney disease (CKD)-Epidemiology Collaboration equation (EPI) 2021)
From baseline (week 0) to end of treatment (week 26)
Change in eGFR (creatinine-based CKD-EPI 2021)
From baseline (week 0) to end of treatment (week 26)
Relative change in body weight
From baseline (week 0) to end of treatment (week 26)
Achievement of greater than or equal to (≥) 5 % weight reduction
From baseline (week 0) to end of treatment (week 26)
Achievement of ≥ 10 % weight reduction
From baseline (week 0) to end of treatment (week 26)
- +8 more secondary outcomes
Study Arms (4)
CagriSema
EXPERIMENTALParticipants will receive cagrilintide and semaglutide subcutaneously once-weekly after a dose escalation period of 16 weeks during the maintenance period for 10 weeks.
Semaglutide
EXPERIMENTALParticipants 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.
Cagrilintide
EXPERIMENTALParticipants 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
PLACEBO COMPARATORParticipants will receive placebo matched to cagrilintide and placebo matched to semaglutide subcutaneously once weekly for 26 weeks.
Interventions
Participants will receive placebo matched to cagrilintide or placebo matched to semaglutide subcutaneously.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (128)
John Muir Physicians Network
Concord, California, 94520, United States
Valley Research
Fresno, California, 93720, United States
Desert Oasis Hlthcr Med Group
Palm Springs, California, 91355, United States
North America Research Institute
San Dimas, California, 91773, United States
NorCal Endocrinology and Internal Medicine
San Ramon, California, 94583, United States
Northeast Research Institute
Fleming Island, Florida, 32003, United States
Life Spring Research Foundation LLC
Miami, Florida, 33130, United States
Advent Health Translational Research Institute
Orlando, Florida, 32804, United States
Velocity Clin. Res Valparaiso
Valparaiso, Indiana, 46383, United States
Elite Research Center
Flint, Michigan, 48532, United States
Univ. of Nebraska Medical Center_Omaha
Omaha, Nebraska, 68198, United States
Albany Medical College
Albany, New York, 12203, United States
NYU Langone Nephrology Associates
Mineola, New York, 11501, United States
New York University Grossman School of Medicine
New York, New York, 10016, United States
Southgate Medical Group, LLP
West Seneca, New York, 14224, United States
Carteret Medical Group
Morehead City, North Carolina, 28557, United States
Eastern Nephrology Associates, PLLC
New Bern, North Carolina, 28562, United States
Brookview Hills Research Associates, LLC
Winston-Salem, North Carolina, 27103, United States
Ohio- Advanced Medical Research
Maumee, Ohio, 43537, United States
Heritage Valley Multispeciality Group Inc
Beaver, Pennsylvania, 15009, United States
Main Street Physician's Care
Little River, South Carolina, 29566, United States
Osvaldo A. Brusco MD
Corpus Christi, Texas, 78414, United States
Southwest Houston Research Ltd
Houston, Texas, 77099, United States
Clinical Advancement Center
San Antonio, Texas, 78212, United States
Clinical Investigation Specialists Inc, Kenosha
Kenosha, Wisconsin, 53144, United States
Mautalen Salud e investigación
CABA, Buenos Aires, C1128 AAF, Argentina
Centro de Investigaciones Médicas Mar del Plata
Mar del Plata, Buenos Aires, B7600GNY, Argentina
Fundación CESIM
Santa Rosa, La Pampa Province, 6300, Argentina
Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
Buenos Aires, C1425AGC, Argentina
Centro Médico Privado San Vicente Diabetes
Córdoba, X5006IKK, Argentina
Instituto Pró-Renal Brasil
Curitiba, Paraná, 80440-020, Brazil
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
Porto Alegre, Rio Grande do Sul, 90430-001, Brazil
CPCLIN - Centro de Pesquisas Clínicas
São Paulo, São Paulo, 01228-200, Brazil
Hospital do Rim e Hipertensao Fundacao Oswaldo Ramos
São Paulo, 04038-002, Brazil
Centricity Research Calgary Endocrinology
Calgary, Alberta, T2H 2G4, Canada
Centricity Research Brampton Endocrinology
Brampton, Ontario, L6S 0C6, Canada
Centricity Research Vaughn Endocrinology
Concord, Ontario, L4K 4M2, Canada
Centricity Research Etobicoke Endocrinology
Etobicoke, Ontario, M9R 4E1, Canada
Hamilton Medical Rsrch Grp
Hamilton, Ontario, L8L 5G4, Canada
Bluewater Clin Res Group Inc
Sarnia, Ontario, N7T 4X3, Canada
UHN-Toronto General Hospital
Toronto, Ontario, M5G 2N2, Canada
Ctr de recherche Clinique de Laval
Laval, Quebec, H7T 2P5, Canada
Centre Medical Acadie
Montreal, Quebec, H4N 2W2, Canada
Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu
Le Creusot, 71200, France
Hôpitaux Saint-Joseph & Marie-Lannelongue
Paris, 75674, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86000, France
Chu de Reims-Hopital Maison Blanche
Reims, 51092, France
Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec
Saint-Herblain, 44800, France
Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil
Toulouse, 31059, France
Centre de Recherche Clinique Portes Du Sud
Vénissieux, 69200, France
University General Hospital Of Heraklion
Heraklion, Crete, 71500, Greece
"Laiko" General Hospital of Athens
Athens, 11527, Greece
Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter
Athens, 11527, Greece
General hospital of Athens 'G.Gennimatas'
Athens, 11527, Greece
Iatriko Athinon 'Palaiou Falirou'
Athens, 17562, Greece
"Laiko" General Hospital of Athens
Athens, GR-11527, Greece
Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter
Athens, GR-11527, Greece
General hospital of Athens 'G.Gennimatas'
Athens, GR-11527, Greece
General Hospital of Lamia
Lamia, 35100, Greece
Univ Gen Hospital Larisa
Larissa, 41110, Greece
Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease
Larissa, GR-41110, Greece
General University Hospital of Patras,Nephrology clinic
Pátrai, GR-26504, Greece
General University Hospital of Patras,Nephrology clinic
Rio, Patra, 26504, Greece
General Hospital of Thessaloniki 'G. Gennimatas
Thessaloniki, 54635, Greece
"Ippokrateio" G.H. of Thessaloniki
Thessaloniki, 54642, Greece
General Hospital of Thessaloniki "Ippokrateio"
Thessaloniki, 54642, Greece
General Hospital of Thessaloniki "G.Papanikolaou"
Thessaloniki, 57010, Greece
General Hospital of Thessaloniki 'G. Gennimatas
Thessaloniki, GR-54635, Greece
"Ippokrateio" G.H. of Thessaloniki
Thessaloniki, GR-54642, Greece
General Hospital of Thessaloniki "G.Papanikolaou"
Thessaloniki, GR-57010, Greece
PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum
Pécs, Baranya Vármegye, 7623, Hungary
Lausmed Kft.
Baja, Bács-Kiskun county, 6500, Hungary
Belinus Bt.
Debrecen, Hajdú-Bihar, 4025, Hungary
Siófoki Kórház, Diabetológiai Szakrendelés
Siófok, Somogy County, 8600, Hungary
Borbánya Praxis E.Ü. Kft.
Nyíregyháza, Szabolcs-Szatmar Varmegye, 4405, Hungary
Szent Margit Rendelőintézet Nonprofit Kft.
Budapest, 1032, Hungary
Békés Megyei Központi Kórház
Gyula, 5700, Hungary
Endolife Specialty Hospitals
Guntur, Andhra Pradesh, 522001, India
NIZAM'S Institute of Medical Sciences
Hyderabad, Andhra Pradesh, 500082, India
Sunrise Hospital
Vijayawada, Andhra Pradesh, 520002, India
Lifecare Hospital and Research Centre
Bengaluru, Karnataka, 560066, India
Seth GS Medical College & KEM Hospital
Mumbai, Maharashtra, 400012, India
King Edward Memorial Hospital
Pune- Maharashtra, Maharashtra, 411011, India
Maulana Azad Medical College
Delhi, New Delhi, 110002, India
Madras Diabetes Research Foundation
Chennai, Tamil Nadu, 600086, India
Shri Mahant Indiresh Hospital
Dehradun, Uttarakhand, 248001, India
Seino Internal Medicine Clinic_Internal medicine
Koriyama-shi, Fukushima, Fukushima, Japan, 963-8851, Japan
Nippon Kokan Fukuyama Hospital_Diabetology
Fukuyama-shi, Hiroshima, 721-0927, Japan
Sasaki Internal Medicine
Hokkaido, 062-0007, Japan
Nishiyamado Keiwa Hospital_Internal Medicine
Ibaraki, 331-0133, Japan
Kanno Naika_Internal Medicine
Mitaka-shi, Tokyo, 181-0013, Japan
Minami Akatsuka Clinic
Mito-shi, Ibaraki, 311-4153, Japan
Tokyo-Eki Center-building Clinic_Internal Medicine
Tokyo, 103-0027, Japan
Fukuwa Clinic_Internal Medicine
Tokyo, 104-0031, Japan
Fukuwa Clinic
Tokyo, 104-0031, Japan
Osteo Medic s.c. Artur Racewicz Jerzy Supronik
Bialystok, Podlaskie Voivodeship, 15-351, Poland
NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
Bialystok, Podlaskie Voivodeship, 15-435, Poland
Kresmed Sp. z o. o.
Bialystok, Podlaskie Voivodeship, 15-481, Poland
M2M Med. Badania Sp. z o.o.
Chorzów, Silesian Voivodeship, 41-500, Poland
M2M Med. Sp. z o.o. Sp. j.
Chorzów, 41-500, Poland
Pratia S.A.
Gdynia, 81-338, Poland
Pratia S.A.
Katowice, 40-081, Poland
Gabinet Lekarski Malgorzata Saryusz-Wolska
Lodz, 90-132, Poland
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
Olsztyn, 10-117, Poland
Gaja Poradnie Lekarskie
Poznan, 61-251, Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Warsaw, 02-507, Poland
Centrum Medyczne Oporow
Wroclaw, 52-416, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
Zabrze, 41-800, Poland
KARDIO-SANUS, spol. s r.o.
Bratislava, 84108, Slovakia
MEDISPEKTRUM s.r.o.
Bratislava, 851 01, Slovakia
HUMAN-CARE, s.r.o.
Košice, 040 01, Slovakia
Univerzitna nemocnica L. Pasteura Kosice
Košice, 040 01, Slovakia
Vysokospecializovany odborny ustav geriatricky sv. Lukasa v Kosiciach, n.o.
Košice, 040 01, Slovakia
Tatratrial s.r.o.
Rožňava, 048 01, Slovakia
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital Fundación Alcorcón
Alcorcón, 28922, Spain
Hospital Vall d'Hebron
Barcelona, 08035, Spain
Hospital de Bellvitge
L'Hospitalet de Llobregat, 08907, Spain
Hospital Gregorio Marañón
Madrid, 28007, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, 38320, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Siriraj Hospital
Bangkok Noi, Bangkok, 10700, Thailand
Thammasat University Hospital
Klong Luang, Changwat Pathum Thani, 12120, Thailand
Maharaj Nakorn Chiang Mai Hospital_Nephrology
Chiang Mai, Mueang Chiang Mai, 50200, Thailand
King Chulalongkorn Memorial Hospital
Bangkok, 10330, Thailand
Phramongkutklao Hospital
Bangkok, 10400, Thailand
Siriraj Hospital
Bangkok, 10700, Thailand
Thammasat Hospital_CRC
Pathum Thani, 12120, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2023
First Posted
November 14, 2023
Study Start
April 1, 2024
Primary Completion
September 24, 2025
Study Completion
November 6, 2025
Last Updated
April 1, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com