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
- Conditions
- Chronic Kidney DiseaseType 2 DiabetesObesity
- Interventions
- Registration Number
- NCT06131372
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 618
- 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 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CagriSema Cagrilintide Participants will receive cagrilintide and semaglutide subcutaneously once-weekly after a dose escalation period of 16 weeks during the maintenance period for 10 weeks. CagriSema Semaglutide Participants will receive cagrilintide and semaglutide subcutaneously once-weekly after a dose escalation period of 16 weeks during the maintenance period for 10 weeks. Semaglutide Semaglutide Participants 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. Semaglutide Placebo Participants 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 Cagrilintide Participants 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. Cagrilintide Placebo Participants 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 Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide subcutaneously once weekly for 26 weeks.
- Primary Outcome Measures
Name Time Method Change in urinary albumin-to-creatinine ratio (UACR) From baseline (week 0) to end of treatment (week 26) Measured in ratio to baseline.
- Secondary Outcome Measures
Name Time Method Achievement of greater than or equal to (≥) 5 % weight reduction From baseline (week 0) to end of treatment (week 26) Count of participants.
Achievement of ≥ 10 % weight reduction From baseline (week 0) to end of treatment (week 26) Count of participants.
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) Measured in milliliters per minute per 1.73 meters square (mL/min/1.73 m\^2).
Relative change in body weight From baseline (week 0) to end of treatment (week 26) Measured in percentage (%).
Change in waist circumference From baseline (week 0) to end of treatment (week 26) Measured in centimeter (cm).
Change in eGFR (creatinine-based CKD-EPI 2021) From baseline (week 0) to end of treatment (week 26) Measured in mL/min/1.73 m\^2.
Change in diastolic blood pressure From baseline (week 0) to end of treatment (week 26) Measured in mmHg.
Number of treatment emergent adverse events (TEAEs) From baseline (week 0) to end of study (week 32) count of events.
Number of treatment emergent serious adverse events (SAEs) From baseline (week 0) to end of study (week 32) count of events.
Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold From baseline (week 0) to end of study (week 32) Count of episodes.
Number of clinically significant hypoglycaemic episodes (level 2) ( blood glucose less than [<] 3.0 millimoles per liter [mmol/L] (54 milligram per deciliter [mg/dL])) From baseline (week 0) to end of study (week 32) Count of episodes.
Change in glycated haemoglobin (HbA1c) From baseline (week 0) to end of treatment (week 26) Measured in %-points.
Change in systolic blood pressure From baseline (week 0) to end of treatment (week 26) Measured in millimeters of mercury (mmHg).
Trial Locations
- Locations (109)
Univerzitna nemocnica L. Pasteura Kosice
🇸🇰Kosice, Slovakia
Szent Margit Rendelőintézet Nonprofit Kft.
🇭🇺Budapest, Hungary
Békés Megyei Központi Kórház
🇭🇺Gyula, Hungary
Velocity Clin. Res Valparaiso
🇺🇸Valparaiso, Indiana, United States
Periphery University Hospital of Heraklion
🇬🇷Heraklion / Crete, Crete, Greece
Elite Research Center
🇺🇸Flint, Michigan, United States
"Laiko" General Hospital of Athens
🇬🇷Athens, Greece
John Muir Physicians Network
🇺🇸Concord, 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
🇺🇸Miami, Florida, United States
Florida Hospital Translational Research Institute
🇺🇸Orlando, Florida, United States
Univ. of Nebraska Medical Center_Omaha
🇺🇸Omaha, Nebraska, United States
Albany Medical College
🇺🇸Albany, New York, United States
NYU Langone Neph Associates
🇺🇸Mineola, New York, United States
New York University 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 Nephr Assoc, 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 Medical Group Inc
🇺🇸Beaver, Pennsylvania, United States
Main Street Physician's Care
🇺🇸Little River, South Carolina, United States
HUMAN-CARE s.r.o.
🇸🇰Kosice, Slovakia
Osvaldo A. Brusco MD PA
🇺🇸Corpus Christi, Texas, United States
Southwest Houston Research Ltd
🇺🇸Houston, Texas, United States
Clinical Advancement Ctr, PLLC
🇺🇸San Antonio, Texas, United States
Clinical Inv Spec, Inc.Kenosha
🇺🇸Kenosha, Wisconsin, United States
Mautalen Salud e investigación
🇦🇷Caba, Buenos Aires, Argentina
Centro de Investigaciones Médicas Clínica de Fracturas y Or
🇦🇷Mar del Plata, Buenos Aires, Argentina
Fundación CESIM
🇦🇷Santa Rosa, La Pampa, Argentina
Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
🇦🇷Buenos Aires, Argentina
Centro Médico Privado San Vicente Diabetes
🇦🇷Córdoba, Argentina
Instituto Pró-Renal Brasil
🇧🇷Curitiba, Parana, Brazil
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
CPCLIN - Centro de Pesquisas Clínicas
🇧🇷São Paulo, Sao Paulo, Brazil
Hospital do Rim e Hipertensao Fundacao Oswaldo Ramos
🇧🇷Sao Paulo, Brazil
Centricity Research Brampton
🇨🇦Brampton, Ontario, Canada
Centricity Research Vaughn
🇨🇦Concord, Ontario, Canada
Centricity Research Etobicoke
🇨🇦Etobicoke, Ontario, Canada
Hamilton Medical Rsrch Grp
🇨🇦Hamilton, Ontario, Canada
Bluewater Clin Res Group Inc
🇨🇦Sarnia, Ontario, Canada
UHN-Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Ctr de rech Clin de Laval
🇨🇦Laval, Quebec, Canada
Centre Medical Acadie
🇨🇦Montreal, Quebec, Canada
Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu-1
🇫🇷Le Creusot, France
Gie Groupe Hospitalier Paris Saint-Joseph/Vinci
🇫🇷Paris Cedex 14, France
Centre Hospitalier Universitaire de Poitiers
🇫🇷Poitiers, France
Centre Hospitalier Universitaire Reims-Hopital Maison Blanche
🇫🇷Reims cedex, France
Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1
🇫🇷Saint Herblain, France
Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1
🇫🇷Toulouse Cedex 9, France
Centre de Recherche Clinique Portes Du Sud
🇫🇷Venissieux, France
Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter
🇬🇷Athens, Greece
General hospital of Athens 'G.Gennimatas'
🇬🇷Athens, Greece
Iatriko Athinon 'Palaiou Falirou'
🇬🇷Athens, Greece
Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease
🇬🇷Larissa, Greece
General University Hospital of Patras,Nephrology clinic
🇬🇷Rio, Patra, Greece
General Hospital of Thessaloniki 'G. Gennimatas
🇬🇷Thessaloniki, Greece
"Ippokrateio" G.H. of Thessaloniki
🇬🇷Thessaloniki, Greece
General Hospital of Thessaloniki "Ippokrateio"
🇬🇷Thessaloniki, Greece
General Hospital of Thessaloniki "G.Papanikolaou"
🇬🇷Thessaloniki, Greece
PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum
🇭🇺Pécs, Baranya Vármegye, Hungary
Lausmed Kft.
🇭🇺Baja, Bács-Kiskun Vármegye, Hungary
Belinus Bt.
🇭🇺Debrecen, Hajdu-Bihar Varmegye, Hungary
Siófoki Kórház, Diabetológiai Szakrendelés
🇭🇺Siófok, Somogy Vármegye, Hungary
Borbánya Praxis E.Ü. Kft.
🇭🇺Nyíregyháza, Szabolcs-Szatmar Varmegye, Hungary
Endolife Specialty Hospitals
🇮🇳Guntur, Andhra Pradesh, India
Sunrise Hospital
🇮🇳Vijayawada, Andhra Pradesh, India
Lifecare Hospital and Research Centre
🇮🇳Bengaluru, Karnataka, India
Seth GS Medical College & KEM Hospital
🇮🇳Mumbai, Maharashtra, India
King Edward Memorial Hospital
🇮🇳Pune- Maharashtra, Maharashtra, India
Maulana Azad Medical College
🇮🇳Delhi, New Delhi, India
Madras Diabetes Research Foundation
🇮🇳Chennai, Tamil Nadu, India
Shri Mahant Indiresh Hospital
🇮🇳Dehradun, Uttarakhand, India
Seino Internal Medicine Clinic
🇯🇵Koriyama-shi, Fukushima, Japan, Japan
Nippon Kokan Fukuyama Hospital_Diabetology
🇯🇵Fukuyama-shi, Hiroshima, Japan
Sasaki Internal Medicine
🇯🇵Hokkaido, Japan
Nishiyamado Keiwa Hospital
🇯🇵Ibaraki,, Japan
Kanno Naika_Internal Medicine
🇯🇵Mitaka-shi, Tokyo, Japan
Minami Akatsuka Clinic
🇯🇵Mito-shi, Ibaraki, Japan
Tokyo-Eki Center-building Clinic
🇯🇵Tokyo, Japan
Fukuwa Clinic
🇯🇵Tokyo, Japan
Osteo Medic s.c. Artur Racewicz Jerzy Supronik
🇵🇱Bialystok, Podlaskie, Poland
NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
🇵🇱Bialystok, Podlaskie, Poland
Kresmed Sp. z o. o.
🇵🇱Bialystok, Podlaskie, Poland
M2M Med. Sp. z o.o. Sp. j.
🇵🇱Chorzow, Poland
Pratia S.A.
🇵🇱Katowice, Poland
Gabinet Lekarski Malgorzata Saryusz-Wolska
🇵🇱Lodz, Poland
Etyka Ośrodek Badań Klinicznych Tomasz Pesta S.K.A.
🇵🇱Olsztyn, Poland
Gaja Poradnie Lekarskie
🇵🇱Poznan, Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
🇵🇱Warszawa, Poland
Centrum Medyczne Oporow
🇵🇱Wroclaw, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
🇵🇱Zabrze, Poland
MEDISPEKTRUM s.r.o.
🇸🇰Bratislava, Slovakia
Vysokospecializovany odborny ustav geriatricky sv. Lukasa v Kosiciach, n.o.
🇸🇰Kosice, Slovakia
Tatratrial s.r.o.
🇸🇰Roznava, Slovakia
Hospital Universitario Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Madrid, Spain
Hospital Fundación Alcorcón
🇪🇸Alcorcon, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital de Bellvitge
🇪🇸Hospitalet de Llobregat, Spain
Hospital Universitario de Canarias
🇪🇸Santa Cruz de Tenerife, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Siriraj Hospital
🇹🇭Bangkok, Thailand
King Chulalongkorn Memorial Hospital
🇹🇭Patumwan, Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hospital
🇹🇭Chiang Mai, Mueang Chiang Mai, Thailand
Thammasat University Hospital
🇹🇭Klong Luang, Pathum Thani, Thailand
Phramongkutklao Hospital
🇹🇭Bangkok, Thailand