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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Type 2 Diabetes; Chronic Kidney Disease
• Intervention / Treatment: Drug: Cagrilintide; Drug: Semaglutide; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 626
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1425AGC
    • Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
  • Córdoba, Argentina, X5006IKK
    • Centro Medico Privado San Vicente Diabetes
  • Buenos Aires
    • CABA, Buenos Aires, Argentina, C1128 AAF
      • Mautalen Salud e Investigación
    • Mar del Plata, Buenos Aires, Argentina, B7600GNY
      • Centro de Investigaciones Medicas Mar del Plata
  • La Pampa Province
    • Santa Rosa, La Pampa Province, Argentina, 6300
      • Fundación CESIM
• Brazil
  • São Paulo, Brazil, 04038-002
    • Hospital Do Rim E Hipertensao Fundacao Oswaldo Ramos
  • Paraná
    • Curitiba, Paraná, Brazil, 80440-020
      • Instituto Pró-Renal Brasil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90430-001
      • Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
  • São Paulo
    • São Paulo, São Paulo, Brazil, 01228-200
      • CPCLIN - Centro de Pesquisas Clínicas
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2H 2G4
      • Centricity Research Calgary Endocrinology
  • Ontario
    • Brampton, Ontario, Canada, L6S 0C6
      • Centricity Research Brampton Endocrinology
    • Concord, Ontario, Canada, L4K 4M2
      • Centricity Research Vaughn Endocrinology
    • Etobicoke, Ontario, Canada, M9R 4E1
      • Centricity Research Etobicoke Endocrinology
    • Hamilton, Ontario, Canada, L8L 5G4
      • Hamilton Medical Rsrch Grp
    • Sarnia, Ontario, Canada, N7T 4X3
      • Bluewater Clin Res Group Inc
    • Toronto, Ontario, Canada, M5G 2N2
      • UHN-Toronto General Hospital
  • Quebec
    • Laval, Quebec, Canada, H7T 2P5
      • Ctr de recherche Clinique de Laval
    • Montreal, Quebec, Canada, H4N 2W2
      • Centre Medical Acadie
• France
  • Le Creusot, France, 71200
    • Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu
  • Paris, France, 75674
    • Hôpitaux Saint-Joseph & Marie-Lannelongue
  • Poitiers, France, 86000
    • Centre Hospitalier Universitaire de Poitiers
  • Reims, France, 51092
    • Chu de Reims-Hopital Maison Blanche
  • Saint-Herblain, France, 44800
    • Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec
  • Toulouse, France, 31059
    • Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil
  • Vénissieux, France, 69200
    • Centre de Recherche Clinique Portes Du Sud
• Greece
  • Athens, Greece, 11527
    • "Laiko" General Hospital of Athens
  • Athens, Greece, GR-11527
    • "Laiko" General Hospital of Athens
  • Athens, Greece, GR-11527
    • Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter
  • Athens, Greece, GR-11527
    • General hospital of Athens 'G.Gennimatas'
  • Athens, Greece, 11527
    • Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter
  • Athens, Greece, 17562
    • Iatriko Athinon 'Palaiou Falirou'
  • Athens, Greece, 11527
    • General hospital of Athens 'G.Gennimatas'
  • Lamia, Greece, 35100
    • General Hospital of Lamia
  • Larissa, Greece, GR-41110
    • Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease
  • Larissa, Greece, 41110
    • Univ Gen Hospital Larisa
  • Pátrai, Greece, GR-26504
    • General University Hospital of Patras,Nephrology clinic
  • Rio, Patra, Greece, 26504
    • General University Hospital of Patras,Nephrology clinic
  • Thessaloniki, Greece, 54642
    • General Hospital of Thessaloniki "Ippokrateio"
  • Thessaloniki, Greece, GR-54635
    • General Hospital of Thessaloniki 'G. Gennimatas
  • Thessaloniki, Greece, GR-57010
    • General Hospital of Thessaloniki "G.Papanikolaou"
  • Thessaloniki, Greece, GR-54642
    • "Ippokrateio" G.H. of Thessaloniki
  • Thessaloniki, Greece, 54642
    • "Ippokrateio" G.H. of Thessaloniki
  • Thessaloniki, Greece, 54635
    • General Hospital of Thessaloniki 'G. Gennimatas
  • Thessaloniki, Greece, 57010
    • General Hospital of Thessaloniki "G.Papanikolaou"
  • Crete
    • Heraklion, Crete, Greece, 71500
      • University General Hospital of Heraklion
• Hungary
  • Budapest, Hungary, 1032
    • Szent Margit Rendelőintézet Nonprofit Kft.
  • Gyula, Hungary, 5700
    • Békés Megyei Központi Kórház
  • Baranya Vármegye
    • Pécs, Baranya Vármegye, Hungary, 7623
      • PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum
  • Bács-Kiskun county
    • Baja, Bács-Kiskun county, Hungary, 6500
      • Lausmed Kft.
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, 4025
      • Belinus Bt.
  • Somogy County
    • Siófok, Somogy County, Hungary, 8600
      • Siófoki Kórház, Diabetológiai Szakrendelés
  • Szabolcs-Szatmar Varmegye
    • Nyíregyháza, Szabolcs-Szatmar Varmegye, Hungary, 4405
      • Borbánya Praxis E.Ü. Kft.
• India
  • Andhra Pradesh
    • Guntur, Andhra Pradesh, India, 522001
      • Endolife Specialty Hospitals
    • Hyderabad, Andhra Pradesh, India, 500082
      • Nizam's Institute of Medical Sciences
    • Vijayawada, Andhra Pradesh, India, 520002
      • Sunrise Hospital
  • Karnataka
    • Bengaluru, Karnataka, India, 560066
      • Lifecare Hospital and Research Centre
  • Maharashtra
    • Mumbai, Maharashtra, India, 400012
      • Seth GS Medical College & KEM Hospital
    • Pune- Maharashtra, Maharashtra, India, 411011
      • King Edward Memorial Hospital
  • New Delhi
    • Delhi, New Delhi, India, 110002
      • Maulana Azad Medical College
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600086
      • Madras Diabetes Research Foundation
  • Uttarakhand
    • Dehradun, Uttarakhand, India, 248001
      • Shri Mahant Indiresh Hospital
• Japan
  • Fukuyama-shi, Hiroshima, Japan, 721-0927
    • Nippon Kokan Fukuyama Hospital_Diabetology
  • Hokkaido, Japan, 062-0007
    • Sasaki Internal Medicine
  • Ibaraki, Japan, 331-0133
    • Nishiyamado Keiwa Hospital_Internal Medicine
  • Mitaka-shi, Tokyo, Japan, 181-0013
    • Kanno Naika_Internal Medicine
  • Mito-shi, Ibaraki, Japan, 311-4153
    • Minami Akatsuka Clinic
  • Tokyo, Japan, 104-0031
    • Fukuwa Clinic
  • Tokyo, Japan, 103-0027
    • Tokyo-Eki Center-building Clinic_Internal Medicine
  • Tokyo, Japan, 104-0031
    • Fukuwa Clinic_Internal Medicine
  • Fukushima, Japan
    • Koriyama-shi, Fukushima, Fukushima, Japan, Japan, 963-8851
      • Seino Internal Medicine Clinic_Internal medicine
• Poland
  • Chorzów, Poland, 41-500
    • M2M Med. Sp. z o.o. Sp. j.
  • Gdynia, Poland, 81-338
    • Pratia S.A.
  • Katowice, Poland, 40-081
    • Pratia S.A.
  • Lodz, Poland, 90-132
    • Gabinet Lekarski Malgorzata Saryusz-Wolska
  • Olsztyn, Poland, 10-117
    • Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
  • Poznan, Poland, 61-251
    • Gaja Poradnie Lekarskie
  • Warsaw, Poland, 02-507
    • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
  • Wroclaw, Poland, 52-416
    • Centrum Medyczne Oporow
  • Zabrze, Poland, 41-800
    • Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
  • Podlaskie Voivodeship
    • Bialystok, Podlaskie Voivodeship, Poland, 15-435
      • NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
    • Bialystok, Podlaskie Voivodeship, Poland, 15-351
      • Osteo Medic s.c. Artur Racewicz Jerzy Supronik
    • Bialystok, Podlaskie Voivodeship, Poland, 15-481
      • Kresmed Sp. z o. o.
  • Silesian Voivodeship
    • Chorzów, Silesian Voivodeship, Poland, 41-500
      • M2M Med. Badania Sp. z o.o.
• Slovakia
  • Bratislava, Slovakia, 851 01
    • MEDISPEKTRUM s.r.o.
  • Bratislava, Slovakia, 84108
    • KARDIO-SANUS, spol. s r.o.
  • Košice, Slovakia, 040 01
    • Univerzitna nemocnica L. Pasteura Kosice
  • Košice, Slovakia, 040 01
    • Vysokospecializovany odborny ustav geriatricky sv. Lukasa v Kosiciach, n.o.
  • Košice, Slovakia, 040 01
    • HUMAN-CARE, s.r.o.
  • Rožňava, Slovakia, 048 01
    • Tatratrial s.r.o.
• Spain
  • Alcorcón, Spain, 28922
    • Hospital Fundación Alcorcón
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron
  • L'Hospitalet de Llobregat, Spain, 08907
    • Hospital De Bellvitge
  • Madrid, Spain, 28007
    • Hospital Gregorio Marañón
  • Santa Cruz de Tenerife, Spain, 38320
    • Hospital Universitario de Canarias
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro Majadahonda
• Thailand
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Memorial Hospital
  • Bangkok, Thailand, 10400
    • Phramongkutklao Hospital
  • Bangkok, Thailand, 10700
    • Siriraj Hospital
  • Pathum Thani, Thailand, 12120
    • Thammasat Hospital_CRC
  • Bangkok
    • Bangkok Noi, Bangkok, Thailand, 10700
      • Siriraj Hospital
  • Changwat Pathum Thani
    • Klong Luang, Changwat Pathum Thani, Thailand, 12120
      • Thammasat University Hospital
  • Mueang Chiang Mai
    • Chiang Mai, Mueang Chiang Mai, Thailand, 50200
      • Maharaj Nakorn Chiang Mai Hospital_Nephrology
• United States
  • California
    • Concord, California, United States, 94520
      • John Muir Physicians Network
    • Fresno, California, United States, 93720
      • Valley Research
    • Palm Springs, California, United States, 91355
      • Desert Oasis Hlthcr Med Group
    • San Dimas, California, United States, 91773
      • North America Research Institute
    • San Ramon, California, United States, 94583
      • NorCal Endocrinology and Internal Medicine
  • Florida
    • Fleming Island, Florida, United States, 32003
      • Northeast Research Institute
    • Miami, Florida, United States, 33130
      • Life Spring Research Foundation LLC
    • Orlando, Florida, United States, 32804
      • Advent Health Translational Research Institute
  • Indiana
    • Valparaiso, Indiana, United States, 46383
      • Velocity Clin. Res Valparaiso
  • Michigan
    • Flint, Michigan, United States, 48532
      • Elite Research Center
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Univ. of Nebraska Medical Center_Omaha
  • New York
    • Albany, New York, United States, 12203
      • Albany Medical College
    • Mineola, New York, United States, 11501
      • NYU Langone Nephrology Associates
    • New York, New York, United States, 10016
      • New York University Grossman School of Medicine
    • West Seneca, New York, United States, 14224
      • Southgate Medical Group, LLP
  • North Carolina
    • Morehead City, North Carolina, United States, 28557
      • Carteret Medical Group
    • New Bern, North Carolina, United States, 28562
      • Eastern Nephrology Associates, PLLC
    • Winston-Salem, North Carolina, United States, 27103
      • Brookview Hills Research Associates, LLC
  • Ohio
    • Maumee, Ohio, United States, 43537
      • Ohio- Advanced Medical Research
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009
      • Heritage Valley Multispeciality Group Inc
  • South Carolina
    • Little River, South Carolina, United States, 29566
      • Main Street Physician's Care
  • Texas
    • Corpus Christi, Texas, United States, 78414
      • Osvaldo A. Brusco MD
    • Houston, Texas, United States, 77099
      • Southwest Houston Research Ltd
    • San Antonio, Texas, United States, 78212
      • Clinical Advancement Center
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53144
      • Clinical Investigation Specialists Inc, Kenosha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CagriSema; Participants will receive cagrilintide and semaglutide subcutaneously once-weekly after a dose escalation period of 16 weeks during the maintenance period for 10 weeks.	Drug: Cagrilintide; Participants will receive Cagrilintide subcutaneously.; Drug: Semaglutide; Participants will receive semaglutide subcutaneously.
Experimental: 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.	Drug: Semaglutide; Participants will receive semaglutide subcutaneously.; Drug: Placebo; Participants will receive placebo matched to cagrilintide or placebo matched to semaglutide subcutaneously.
Experimental: 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.	Drug: Cagrilintide; Participants will receive Cagrilintide subcutaneously.; Drug: Placebo; Participants will receive placebo matched to cagrilintide or placebo matched to semaglutide subcutaneously.
Placebo Comparator: Placebo; Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide subcutaneously once weekly for 26 weeks.	Drug: Placebo; Participants will receive placebo matched to cagrilintide or placebo matched to semaglutide subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in urinary albumin-to-creatinine ratio (UACR)	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 26)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in estimated glomerular filtration rate (eGFR) (creatinine and cystatin C-based chronic kidney disease (CKD)-Epidemiology Collaboration equation (EPI) 2021)	Measured in milliliters per minute per 1.73 meters square (mL/min/1.73 m^2).	From baseline (week 0) to end of treatment (week 26)
Change in eGFR (creatinine-based CKD-EPI 2021)	Measured in mL/min/1.73 m^2.	From baseline (week 0) to end of treatment (week 26)
Relative change in body weight	Measured in percentage (%).	From baseline (week 0) to end of treatment (week 26)
Achievement of greater than or equal to (≥) 5 % weight reduction	Count of participants.	From baseline (week 0) to end of treatment (week 26)
Achievement of ≥ 10 % weight reduction	Count of participants.	From baseline (week 0) to end of treatment (week 26)
Change in waist circumference	Measured in centimeter (cm).	From baseline (week 0) to end of treatment (week 26)
Change in glycated haemoglobin (HbA1c)	Measured in %-points.	From baseline (week 0) to end of treatment (week 26)
Change in systolic blood pressure	Measured in millimeters of mercury (mmHg).	From baseline (week 0) to end of treatment (week 26)
Change in diastolic blood pressure	Measured in mmHg.	From baseline (week 0) to end of treatment (week 26)
Number of treatment emergent adverse events (TEAEs)	count of events.	From baseline (week 0) to end of study (week 32)
Number of treatment emergent serious adverse events (SAEs)	count of events.	From baseline (week 0) to end of study (week 32)
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]))	Count of episodes.	From baseline (week 0) to end of study (week 32)
Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold	Count of episodes.	From baseline (week 0) to end of study (week 32)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): September 24, 2025
• Study Completion (Actual): November 6, 2025

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Nutrition Disorders; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Renal Insufficiency; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic; Substandard Drugs; Pharmaceutical Preparations; semaglutide; cagrilintide
• Other Study ID Numbers: NN9388-7700; U1111-1291-5907 (Other Identifier: World Health Organization (WHO)); 2023-505857-42 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No