NCT06131372CompletedPhase 2
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
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 626 (actual)
- First submitted
- 9 Nov 2023
- Start date
- 1 Apr 2024
- Primary completion date
- 24 Sept 2025
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Chronic kidney disease, Obesity, Type 2 diabetes
- NCT number
- NCT06131372
- EU CT number
- 2023-505857-42-00
- EudraCT number
- 2023-505857-42
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 626
- From 1 Apr 2024 to the primary completion date, 24 Sept 2025
- 117 sites in 13 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations.
- 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.
Other
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (117)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Mautalen- Salud e Investigacion Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Centro Medico Privado San Vicente Diabetes Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Centro de Investigaciones Medicas Mar Del Plata Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Unknown status |
| Fundación CESIM Coordinator of this site? Confirm its status | Santa Rosa | Argentina | Unknown status |
| Instituto Pro Renal Brasil Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda. Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| CPCLIN - Centro de Pesquisas Clínicas Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Hospital do Rim e Hipertensao Fundacao Oswaldo Ramos Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Centricity Research Brampton Endocrinology Coordinator of this site? Confirm its status | Brampton | Canada | Unknown status |
| Centricity Research Calgary Endocrinology Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Centricity Research Vaughn Endocrinology Coordinator of this site? Confirm its status | Concord | Canada | Unknown status |
| Centricity Research Etobicoke Endocrinology Coordinator of this site? Confirm its status | Etobicoke | Canada | Unknown status |
| Hamilton Medical Research Group Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Ctr de recherche Clinique de Laval Coordinator of this site? Confirm its status | Laval | Canada | Unknown status |
| Centre Medical Acadie Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Bluewater Clin Res Group Inc Coordinator of this site? Confirm its status | Sarnia | Canada | Unknown status |
| UHN-Toronto General Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario De Canarias Coordinator of this site? Confirm its status | La Laguna | Spain | Completed |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Completed |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Fundacion Alcorcon Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Completed |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Groupe Sos Sante Coordinator of this site? Confirm its status | Le Creusot | France | Completed |
| GIE Groupe hospitalier Paris Saint-Joseph/Vinci Coordinator of this site? Confirm its status | Paris Cedex 14 | France | Completed |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Completed |
| Centre Hospitalier Universitaire Reims Coordinator of this site? Confirm its status | Reims Cedex | France | Completed |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Completed |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Completed |
| Centre de Recherche Clinique Portes Du Sud Coordinator of this site? Confirm its status | Vénissieux | France | Completed |
| Laiko General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| General Hospital of Athens "G. Gennimatas" Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| University General Hospital of Heraklion Coordinator of this site? Confirm its status | Heraklion | Greece | Completed |
| Athens Medical Center S.A. Coordinator of this site? Confirm its status | Paleo Faliro | Greece | Completed |
| General University Hospital Of Patras Coordinator of this site? Confirm its status | Patras | Greece | Completed |
| Hippokration Hospital Coordinator of this site? Confirm its status | Thessaloniki | Greece | Completed |
| General Hospital Of Thessloniki G Gennimatas Coordinator of this site? Confirm its status | Thessaloniki | Greece | Completed |
| Ippokratio General Hospital of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Completed |
| Geniko Nosokomeio Thessalonikis George Papanikolaou Coordinator of this site? Confirm its status | Thessaloniki | Greece | Completed |
| Lausmed Kft Coordinator of this site? Confirm its status | Baja | Hungary | Completed |
| Szent Margit Rendelointezet Nonprofit Kft. Coordinator of this site? Confirm its status | Budapest III | Hungary | Completed |
| Belinus Bt. Coordinator of this site? Confirm its status | Debrecen | Hungary | Completed |
| Bekes Varmegyei Koezponti Korhaz Coordinator of this site? Confirm its status | Gyula | Hungary | Completed |
| Borbanya Praxis Egeszsegugyi Kft Coordinator of this site? Confirm its status | Nyíregyháza | Hungary | Completed |
| University of Pecs Coordinator of this site? Confirm its status | Pécs | Hungary | Completed |
| Siofoki Korhaz-Rendelointezet Coordinator of this site? Confirm its status | Siofok | Hungary | Completed |
| Lifecare Hospital and Research Centre Coordinator of this site? Confirm its status | Bengaluru | India | Unknown status |
| Madras Diabetes Research Foundation Coordinator of this site? Confirm its status | Chennai | India | Unknown status |
| Shri Mahant Indiresh Hospital Coordinator of this site? Confirm its status | Dehradun | India | Unknown status |
| Maulana Azad Medical College Coordinator of this site? Confirm its status | Delhi | India | Unknown status |
| Endolife Specialty Hospitals Coordinator of this site? Confirm its status | Guntur | India | Unknown status |
| Nizam's Institute of Medical Sciences Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| Seth GS Medical College & KEM Hospital Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| King Edward Memorial Hospital Coordinator of this site? Confirm its status | Pune- Maharashtra | India | Unknown status |
| Sunrise Hospital Coordinator of this site? Confirm its status | Vijayawada | India | Unknown status |
| Nippon Kokan Fukuyama Hospital_Diabetology Coordinator of this site? Confirm its status | Fukuyama-shi, Hiroshima | Japan | Unknown status |
| Sasaki Internal Medicine Coordinator of this site? Confirm its status | Hokkaido | Japan | Unknown status |
| Nishiyamado Keiwa Hospital_Internal Medicine Coordinator of this site? Confirm its status | Ibaraki | Japan | Unknown status |
| Seino Internal Medicine Clinic_Internal medicine Coordinator of this site? Confirm its status | Koriyama-shi, Fukushima | Japan | Unknown status |
| Kanno Naika_Internal Medicine Coordinator of this site? Confirm its status | Mitaka-shi, Tokyo | Japan | Unknown status |
| Minami Akatsuka Clinic Coordinator of this site? Confirm its status | Mito-shi, Ibaraki | Japan | Unknown status |
| Minami Akatsuka Clinic_internal medicine Coordinator of this site? Confirm its status | Mito-shi, Ibaraki | Japan | Unknown status |
| Tokyo-Eki Center-building Clinic_Internal Medicine Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Fukuwa Clinic_Internal Medicine Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Fukuwa Clinic Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Kresmed Sp. z o. o. Coordinator of this site? Confirm its status | Bialystok | Poland | Completed |
| Niepublicznego Zakladu Opieki Zdrowotnej Specjalistyczny Osrodek Internistyczno Diabetologiczny Coordinator of this site? Confirm its status | Bialystok | Poland | Completed |
| ZDROWIE OSTEO-MEDIC s.c. Coordinator of this site? Confirm its status | Bialystok | Poland | Completed |
| M2M Med. Sp. z o.o. Sp. j. Coordinator of this site? Confirm its status | Chorzow | Poland | Completed |
| Pratia S.A. Coordinator of this site? Confirm its status | Gdynia | Poland | Completed |
| Pratia S.A. Coordinator of this site? Confirm its status | Katowice | Poland | Completed |
| Gabinet Lekarski Malgorzata Saryusz-Wolska Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A. Coordinator of this site? Confirm its status | Olsztyn | Poland | Completed |
| Gaja Poradnie Lekarskie Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Centrum Medyczne Oporow Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach Coordinator of this site? Confirm its status | Zabrze | Poland | Completed |
| Kardio-Sanus spol. s r.o. Coordinator of this site? Confirm its status | Devinska Nova Ves | Slovakia | Completed |
| Univerzitna nemocnica L. Pasteura Kosice Coordinator of this site? Confirm its status | Košice | Slovakia | Completed |
| Vysokospecializovany Odborny ustav Geriatricky sv. Lukasa v Kosiciach n.o. Coordinator of this site? Confirm its status | Košice | Slovakia | Completed |
| Human-Care s.r.o. Coordinator of this site? Confirm its status | Kosice 1 | Slovakia | Completed |
| Medispektrum s.r.o. Coordinator of this site? Confirm its status | Petrzalka | Slovakia | Completed |
| Tatratrial s.r.o. Coordinator of this site? Confirm its status | Rožňava | Slovakia | Completed |
| King Chulalongkorn Memorial Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Siriraj Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Phramongkutklao Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Siriraj Hospital Coordinator of this site? Confirm its status | Bangkok Noi | Thailand | Unknown status |
| Maharaj Nakorn Chiang Mai Hospital_Nephrology Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Unknown status |
| Thammasat University Hospital Coordinator of this site? Confirm its status | Klong Luang | Thailand | Unknown status |
| Thammasat Hospital_CRC Coordinator of this site? Confirm its status | Pathum Thani | Thailand | Unknown status |
| Albany Medical College Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| Heritage Valley Multispeciality Group Inc Coordinator of this site? Confirm its status | Beaver | United States | Unknown status |
| John Muir Physicians Network Coordinator of this site? Confirm its status | Concord | United States | Unknown status |
| Osvaldo A. Brusco MD Coordinator of this site? Confirm its status | Corpus Christi | United States | Unknown status |
| Northeast Research Institute Coordinator of this site? Confirm its status | Fleming Island | United States | Unknown status |
| Elite Research Center Coordinator of this site? Confirm its status | Flint | United States | Unknown status |
| Valley Research Coordinator of this site? Confirm its status | Fresno | United States | Unknown status |
| Southwest Houston Research Ltd Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Clinical Investigation Specialists Inc, Kenosha Coordinator of this site? Confirm its status | Kenosha | United States | Unknown status |
| Main Street Physician's Care Coordinator of this site? Confirm its status | Little River | United States | Unknown status |
| Ohio- Advanced Medical Research Coordinator of this site? Confirm its status | Maumee | United States | Unknown status |
| Life Spring Research Foundation, LLC Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| NYU Langone Nephrology Associates Coordinator of this site? Confirm its status | Mineola | United States | Unknown status |
| Carteret Medical Group Coordinator of this site? Confirm its status | Morehead City | United States | Unknown status |
| Eastern Nephrology Associates, PLLC Coordinator of this site? Confirm its status | New Bern | United States | Unknown status |
| New York University Grossman School of Medicine Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Univ. of Nebraska Medical Center_Omaha Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Advent Health Translational Research Institute Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Desert Oasis Hlthcr Med Group Coordinator of this site? Confirm its status | Palm Springs | United States | Unknown status |
| Clinical Advancement Center Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| North America Research Institute Coordinator of this site? Confirm its status | San Dimas | United States | Unknown status |
| NorCal Endocrinology and Internal Medicine Coordinator of this site? Confirm its status | San Ramon | United States | Unknown status |
| Velocity Clin. Res Valparaiso Coordinator of this site? Confirm its status | Valparaiso | United States | Unknown status |
| Southgate Medical Group, LLP Coordinator of this site? Confirm its status | West Seneca | United States | Unknown status |
| Brookview Hills Research Associates, LLC Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.