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 2.4 mg, semaglutide 2.4 mg, cagrilintide 2.4 mg 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: Recruiting
• Conditions: Obesity; Type 2 Diabetes; Chronic Kidney Disease
• Intervention / Treatment: Drug: Cagrilintide; Drug: Semaglutide; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 618
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1425AGC
    • Not yet recruiting
    • Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
  • Córdoba, Argentina, X5006IKK
    • Not yet recruiting
    • Centro Medico Privado San Vicente Diabetes
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1128 AAF
      • Not yet recruiting
      • Mautalen Salud e Investigación
    • Mar del Plata, Buenos Aires, Argentina, B7600GNY
      • Not yet recruiting
      • Centro de Investigaciones Médicas Clínica de Fracturas y Or
  • La Pampa
    • Santa Rosa, La Pampa, Argentina, 6300
      • Not yet recruiting
      • Fundación CESIM
• Brazil
  • Sao Paulo, Brazil, 04038-002
    • Not yet recruiting
    • Hospital do Rim e Hipertensao Fundacao Oswaldo Ramos
  • Parana
    • Curitiba, Parana, Brazil, 80440-020
      • Not yet recruiting
      • Instituto Pró-Renal Brasil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90430-001
      • Not yet recruiting
      • Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
  • Sao Paulo
    • São Paulo, Sao Paulo, Brazil, 01228-200
      • Not yet recruiting
      • CPCLIN - Centro de Pesquisas Clínicas
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2H 2G4
      • Not yet recruiting
      • Centricity Research Calgary
  • Ontario
    • Concord, Ontario, Canada, L4K 4M2
      • Recruiting
      • Centricity Research Vaughn
    • Hamilton, Ontario, Canada, L8M 1K7
      • Recruiting
      • Hamilton Medical Rsrch Grp
    • Sarnia, Ontario, Canada, N7T 4X3
      • Recruiting
      • Bluewater Clin Res Group Inc
    • Toronto, Ontario, Canada, M5G 2N2
      • Not yet recruiting
      • UHN-Toronto General Hospital
  • Quebec
    • Laval, Quebec, Canada, H7T 2P5
      • Recruiting
      • Ctr de rech Clin de Laval
    • Montreal, Quebec, Canada, H4N 2W2
      • Recruiting
      • Centre Medical Acadie
• France
  • Le Creusot, France, 71200
    • Not yet recruiting
    • Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu-1
  • Paris Cedex 14, France, 75674
    • Not yet recruiting
    • Gie Groupe Hospitalier Paris Saint-Joseph/Vinci
  • Poitiers, France, 86000
    • Not yet recruiting
    • Centre Hospitalier Universitaire de Poitiers
  • Reims cedex, France, 51092
    • Not yet recruiting
    • Centre Hospitalier Universitaire Reims-Hopital Maison Blanche
  • Saint Herblain, France, 44800
    • Not yet recruiting
    • Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1
  • Toulouse Cedex 9, France, 31059
    • Not yet recruiting
    • Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1
• Greece
  • Athens, Greece, GR-11527
    • Not yet recruiting
    • "Laiko" General Hospital of Athens
  • Athens, Greece, GR-11527
    • Not yet recruiting
    • General hospital of Athens 'G.Gennimatas'
  • Athens, Greece, GR-17562
    • Not yet recruiting
    • Iatriko Athinon 'Palaiou Falirou'
  • Athens, Greece, GR-11527
    • Not yet recruiting
    • Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter
  • Lamia, Greece, GR35100
    • Not yet recruiting
    • General Hospital of Lamia
  • Larissa, Greece, GR-41110
    • Not yet recruiting
    • Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease
  • Patra, Greece, GR-26504
    • Not yet recruiting
    • General University Hospital of Patras,Nephrology clinic
  • Rio, Patra, Greece, GR-26504
    • Not yet recruiting
    • General University Hospital of Patras,Nephrology clinic
  • Thessaloniki, Greece, GR-57010
    • Not yet recruiting
    • General Hospital of Thessaloniki "G.Papanikolaou"
  • Thessaloniki, Greece, GR-54635
    • Not yet recruiting
    • General Hospital of Thessaloniki 'G. Gennimatas
  • Thessaloniki, Greece, GR-54642
    • Not yet recruiting
    • "Ippokrateio" G.H. of Thessaloniki
• Hungary
  • Budapest, Hungary, 1032
    • Not yet recruiting
    • Szent Margit Rendelőintézet Nonprofit Kft.
  • Baranya Vármegye
    • Pécs, Baranya Vármegye, Hungary, 7623
      • Not yet recruiting
      • PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum
  • Bács-Kiskun Vármegye
    • Baja, Bács-Kiskun Vármegye, Hungary, 6500
      • Not yet recruiting
      • Lausmed Kft.
  • Hajdu-Bihar Varmegye
    • Debrecen, Hajdu-Bihar Varmegye, Hungary, 4025
      • Not yet recruiting
      • Belinus Bt.
  • Somogy Vármegye
    • Siófok, Somogy Vármegye, Hungary, 8600
      • Not yet recruiting
      • Siófoki Kórház, Diabetológiai Szakrendelés
  • Szabolcs-Szatmar Varmegye
    • Nyíregyháza, Szabolcs-Szatmar Varmegye, Hungary, 4405
      • Not yet recruiting
      • Borbánya Praxis E.Ü. Kft.
• India
  • Andhra Pradesh
    • Guntur, Andhra Pradesh, India, 522001
      • Not yet recruiting
      • Endolife Specialty Hospitals
  • Karnataka
    • Bengaluru, Karnataka, India, 560066
      • Not yet recruiting
      • Lifecare Hospital and Research Centre
  • Maharashtra
    • Mumbai, Maharashtra, India, 400012
      • Not yet recruiting
      • Seth GS Medical College & KEM Hospital
    • Pune- Maharashtra, Maharashtra, India, 411011
      • Not yet recruiting
      • King Edward Memorial Hospital
  • New Delhi
    • Delhi, New Delhi, India, 110002
      • Not yet recruiting
      • Maulana Azad Medical College
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600086
      • Not yet recruiting
      • Madras Diabetes Research Foundation
  • Uttarakhand
    • Dehradun, Uttarakhand, India, 248001
      • Not yet recruiting
      • Shri Mahant Indiresh Hospital
• Japan
  • Fukuyama-shi, Hiroshima, Japan, 721-0927
    • Recruiting
    • Nippon Kokan Fukuyama Hospital_Diabetology
  • Ibaraki,, Japan, 331-0133
    • Not yet recruiting
    • Nishiyamado Keiwa Hospital
  • Mitaka-shi, Tokyo, Japan, 181-0013
    • Recruiting
    • Kanno Naika_Internal Medicine
  • Mito-shi, Ibaraki, Japan, 311-4153
    • Not yet recruiting
    • Minami Akatsuka Clinic
  • Tokyo, Japan, 103-0027
    • Recruiting
    • Tokyo-Eki Center-Building Clinic
  • Tokyo, Japan, 104-0031
    • Recruiting
    • Fukuwa Clinic
  • Tokyo, Japan, 104-0031
    • Not yet recruiting
    • Fukuwa Clinic
  • Fukushima, Japan
    • Koriyama-shi, Fukushima, Japan, Japan, 963-8851
      • Not yet recruiting
      • Seino Internal Medicine Clinic
• Poland
  • Gdynia, Poland, 81-338
    • Not yet recruiting
    • Pratia S.A.
  • Katowice, Poland, 40-081
    • Not yet recruiting
    • Pratia S.A.
  • Katowice, Poland, 40-083
    • Not yet recruiting
    • M2M Med. Sp. z o.o. Sp. j.
  • Olsztyn, Poland, 10-117
    • Not yet recruiting
    • Etyka Ośrodek Badań Klinicznych Tomasz Pesta S.K.A.
  • Poznan, Poland, 61-251
    • Not yet recruiting
    • Gaja Poradnie Lekarskie
  • Warszawa, Poland, 02-507
    • Not yet recruiting
    • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
  • Wroclaw, Poland, 52-416
    • Not yet recruiting
    • Centrum Medyczne Oporow
  • Podlaskie
    • Bialystok, Podlaskie, Poland, 15-351
      • Not yet recruiting
      • Osteo Medic s.c. Artur Racewicz Jerzy Supronik
    • Bialystok, Podlaskie, Poland, 15-481
      • Not yet recruiting
      • Kresmed Sp. z o. o.
• Slovakia
  • Bratislava, Slovakia, 851 01
    • Not yet recruiting
    • MEDISPEKTRUM s.r.o.
  • Kosice, Slovakia, 040 01
    • Not yet recruiting
    • HUMAN-CARE s.r.o.
  • Kosice, Slovakia, 040 01
    • Not yet recruiting
    • Univerzitna nemocnica L. Pasteura Kosice
  • Kosice, Slovakia, 040 01
    • Not yet recruiting
    • Vysokospecializovany odborny ustav geriatricky sv. Lukasa v Kosiciach, n.o.
  • Roznava, Slovakia, 048 01
    • Not yet recruiting
    • Tatratrial s.r.o.
• Spain
  • Alcorcon, Spain, 28922
    • Not yet recruiting
    • Hospital Fundación Alcorcón
  • Hospitalet de Llobregat, Spain, 08907
    • Not yet recruiting
    • Hospital de Bellvitge
  • Santa Cruz de Tenerife, Spain, 38320
    • Not yet recruiting
    • Hospital Universitario de Canarias
  • Valencia, Spain, 46010
    • Not yet recruiting
    • Hospital Clínico Universitario de Valencia
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Not yet recruiting
      • Hospital Universitario Puerta de Hierro Majadahonda
• Thailand
  • Bangkok, Thailand, 10700
    • Not yet recruiting
    • Siriraj Hospital
  • Bangkok, Thailand, 10400
    • Not yet recruiting
    • Phramongkutklao Hospital
  • Bangkok
    • Bangkok Noi, Bangkok, Thailand, 10700
      • Not yet recruiting
      • Siriraj Hospital
    • Patumwan, Bangkok, Thailand, 10330
      • Not yet recruiting
      • King Chulalongkorn Memorial Hospital
  • Mueang Chiang Mai District
    • Chiang Mai, Mueang Chiang Mai District, Thailand, 50200
      • Not yet recruiting
      • Maharaj Nakorn Chiang Mai Hospital
  • Pathum Thani
    • Klong Luang, Pathum Thani, Thailand, 12120
      • Not yet recruiting
      • Thammasat University Hospital
• United States
  • California
    • Concord, California, United States, 94520
      • Recruiting
      • John Muir Physician Network
    • Fresno, California, United States, 93720
      • Withdrawn
      • Valley Research
    • Palm Springs, California, United States, 92262
      • Recruiting
      • Desert Oasis Hlthcr Med Group
    • San Dimas, California, United States, 91773
      • Recruiting
      • North America Research Institute
    • San Ramon, California, United States, 94583
      • Recruiting
      • NorCal Endocrinology and Internal Medicine
  • Florida
    • Fleming Island, Florida, United States, 32003
      • Recruiting
      • Northeast Research Institute
    • Orlando, Florida, United States, 32804
      • Not yet recruiting
      • Florida Hospital Translational Research Institute
  • Indiana
    • Valparaiso, Indiana, United States, 46383
      • Recruiting
      • Velocity Clin. Res Valparaiso
  • Michigan
    • Flint, Michigan, United States, 48532
      • Recruiting
      • Elite Research Center
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Not yet recruiting
      • Univ. of Nebraska Medical Center_Omaha
  • New York
    • Albany, New York, United States, 12208
      • Not yet recruiting
      • Albany Medical College
    • Mineola, New York, United States, 11501
      • Not yet recruiting
      • NYU Langone Neph Associates
    • New York, New York, United States, 10016
      • Not yet recruiting
      • New York University School of Medicine
    • West Seneca, New York, United States, 14224
      • Recruiting
      • Southgate Medical Group, LLP
  • North Carolina
    • Cary, North Carolina, United States, 27513
      • Recruiting
      • Carteret Medical Group
    • Winston-Salem, North Carolina, United States, 27103
      • Recruiting
      • Brookview Hills Research Associates, LLC
  • Ohio
    • Maumee, Ohio, United States, 43537
      • Recruiting
      • Ohio- Advanced Medical Research
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009
      • Recruiting
      • Heritage Valley Medical Group Inc
  • South Carolina
    • Little River, South Carolina, United States, 29566
      • Recruiting
      • Main Street Physician's Care
  • Texas
    • Corpus Christi, Texas, United States, 78414
      • Recruiting
      • Osvaldo A. Brusco MD PA
    • Houston, Texas, United States, 77099
      • Not yet recruiting
      • Southwest Houston Research Ltd
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53144
      • Not yet recruiting
      • Clinical Inv Spec, 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 a fundus 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 2.4 mg/2.4 mg; Participants will receive 2.4 milligram (mg) cagrilintide and 2.4 mg 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 2.4 mg; Participants will receive semaglutide 2.4 mg 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 2.4 mg; Participants will receive cagrilintide 2.4 mg 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 2.4 mg 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 (Estimated): October 13, 2025
• Study Completion (Estimated): December 1, 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 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Urologic Diseases; Endocrine System Diseases; Disease Attributes; Renal Insufficiency; Overnutrition; Nutrition Disorders; Body Weight; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Kidney Diseases; Renal Insufficiency, Chronic; Obesity; Overweight; Hypoglycemic Agents; Physiological Effects of Drugs; Glucagon-Like Peptide-1 Receptor Agonists; Semaglutide
• 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