Clinical trial NCT06131372: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Chronic Kidney Disease
Type 2 Diabetes
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-11-14
Enrollment: 618
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in urinary albumin-to-creatinine ratio (UACR)
timeFrame: From baseline (week 0) to end of treatment (week 26)
Secondary outcomes:
measure: Change in estimated glomerular filtration rate (eGFR) (creatinine and cystatin C-based chronic kidney disease (CKD)-Epidemiology Collaboration equation (EPI) 2021)
timeFrame: From baseline (week 0) to end of treatment (week 26)
measure: Change in eGFR (creatinine-based CKD-EPI 2021)
timeFrame: From baseline (week 0) to end of treatment (week 26)
measure: Relative change in body weight
timeFrame: From baseline (week 0) to end of treatment (week 26)
measure: Achievement of greater than or equal to (≥) 5 % weight reduction
timeFrame: From baseline (week 0) to end of treatment (week 26)
measure: Achievement of ≥ 10 % weight reduction
timeFrame: From baseline (week 0) to end of treatment (week 26)
measure: Change in waist circumference
timeFrame: From baseline (week 0) to end of treatment (week 26)
measure: Change in glycated haemoglobin (HbA1c)
timeFrame: From baseline (week 0) to end of treatment (week 26)
measure: Change in systolic blood pressure
timeFrame: From baseline (week 0) to end of treatment (week 26)
measure: Change in diastolic blood pressure
timeFrame: From baseline (week 0) to end of treatment (week 26)
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: From baseline (week 0) to end of study (week 32)
measure: Number of treatment emergent serious adverse events (SAEs)
timeFrame: From baseline (week 0) to end of study (week 32)
measure: 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]))
timeFrame: From baseline (week 0) to end of study (week 32)
measure: Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold
timeFrame: From baseline (week 0) to end of study (week 32)
Other outcomes:
Locations:
city: Concord
country: United States
facility: John Muir Physicians Network
state: California
city: Palm Springs
country: United States
facility: Desert Oasis Hlthcr Med Group
state: California
city: San Dimas
country: United States
facility: North America Research Institute
state: California
city: San Ramon
country: United States
facility: NorCal Endocrinology and Internal Medicine
state: California
city: Fleming Island
country: United States
facility: Northeast Research Institute
state: Florida
city: Miami
country: United States
facility: Life Spring Research
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Translational Research Institute
state: Florida
city: Valparaiso
country: United States
facility: Velocity Clin. Res Valparaiso
state: Indiana
city: Flint
country: United States
facility: Elite Research Center
state: Michigan
city: Omaha
country: United States
facility: Univ. of Nebraska Medical Center_Omaha
state: Nebraska
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Mineola
country: United States
facility: NYU Langone Neph Associates
state: New York
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: West Seneca
country: United States
facility: Southgate Medical Group, LLP
state: New York
city: Morehead City
country: United States
facility: Carteret Medical Group
state: North Carolina
city: New Bern
country: United States
facility: Eastern Nephr Assoc, PLLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Brookview Hills Research Associates, LLC
state: North Carolina
city: Maumee
country: United States
facility: Ohio- Advanced Medical Research
state: Ohio
city: Beaver
country: United States
facility: Heritage Valley Medical Group Inc
state: Pennsylvania
city: Little River
country: United States
facility: Main Street Physician's Care
state: South Carolina
city: Corpus Christi
country: United States
facility: Osvaldo A. Brusco MD PA
state: Texas
city: Houston
country: United States
facility: Southwest Houston Research Ltd
state: Texas
city: San Antonio
country: United States
facility: Clinical Advancement Ctr, PLLC
state: Texas
city: Kenosha
country: United States
facility: Clinical Inv Spec, Inc.Kenosha
state: Wisconsin
city: Caba
country: Argentina
facility: Mautalen Salud e investigación
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Centro de Investigaciones Médicas Clínica de Fracturas y Or
state: Buenos Aires
city: Santa Rosa
country: Argentina
facility: Fundación CESIM
state: La Pampa
city: Buenos Aires
country: Argentina
facility: Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
city: Córdoba
country: Argentina
facility: Centro Médico Privado San Vicente Diabetes
city: Curitiba
country: Brazil
facility: Instituto Pró-Renal Brasil
state: Parana
city: Porto Alegre
country: Brazil
facility: Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
state: Rio Grande Do Sul
city: São Paulo
country: Brazil
facility: CPCLIN - Centro de Pesquisas Clínicas
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Hospital do Rim e Hipertensao Fundacao Oswaldo Ramos
city: Brampton
country: Canada
facility: Centricity Research Brampton
state: Ontario
city: Concord
country: Canada
facility: Centricity Research Vaughn
state: Ontario
city: Etobicoke
country: Canada
facility: Centricity Research Etobicoke
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Medical Rsrch Grp
state: Ontario
city: Sarnia
country: Canada
facility: Bluewater Clin Res Group Inc
state: Ontario
city: Toronto
country: Canada
facility: UHN-Toronto General Hospital
state: Ontario
city: Laval
country: Canada
facility: Ctr de rech Clin de Laval
state: Quebec
city: Montreal
country: Canada
facility: Centre Medical Acadie
state: Quebec
city: Le Creusot
country: France
facility: Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu-1
city: Paris Cedex 14
country: France
facility: Gie Groupe Hospitalier Paris Saint-Joseph/Vinci
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers
city: Reims cedex
country: France
facility: Centre Hospitalier Universitaire Reims-Hopital Maison Blanche
city: Saint Herblain
country: France
facility: Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1
city: Toulouse Cedex 9
country: France
facility: Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1
city: Venissieux
country: France
facility: Centre de Recherche Clinique Portes Du Sud
city: Heraklion / Crete
country: Greece
facility: Periphery University Hospital of Heraklion
state: Crete
city: Athens
country: Greece
facility: "Laiko" General Hospital of Athens
city: Athens
country: Greece
facility: Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter
city: Athens
country: Greece
facility: General hospital of Athens 'G.Gennimatas'
city: Athens
country: Greece
facility: Iatriko Athinon 'Palaiou Falirou'
city: Athens
country: Greece
facility: "Laiko" General Hospital of Athens
city: Athens
country: Greece
facility: Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter
city: Athens
country: Greece
facility: General hospital of Athens 'G.Gennimatas'
city: Larissa
country: Greece
facility: Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease
city: Patra
country: Greece
facility: General University Hospital of Patras,Nephrology clinic
city: Rio, Patra
country: Greece
facility: General University Hospital of Patras,Nephrology clinic
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki 'G. Gennimatas
city: Thessaloniki
country: Greece
facility: "Ippokrateio" G.H. of Thessaloniki
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "Ippokrateio"
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "G.Papanikolaou"
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki 'G. Gennimatas
city: Thessaloniki
country: Greece
facility: "Ippokrateio" G.H. of Thessaloniki
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "G.Papanikolaou"
city: Pécs
country: Hungary
facility: PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum
state: Baranya Vármegye
city: Baja
country: Hungary
facility: Lausmed Kft.
state: Bács-Kiskun Vármegye
city: Debrecen
country: Hungary
facility: Belinus Bt.
state: Hajdu-Bihar Varmegye
city: Siófok
country: Hungary
facility: Siófoki Kórház, Diabetológiai Szakrendelés
state: Somogy Vármegye
city: Nyíregyháza
country: Hungary
facility: Borbánya Praxis E.Ü. Kft.
state: Szabolcs-Szatmar Varmegye
city: Budapest
country: Hungary
facility: Szent Margit Rendelőintézet Nonprofit Kft.
city: Gyula
country: Hungary
facility: Békés Megyei Központi Kórház
city: Guntur
country: India
facility: Endolife Specialty Hospitals
state: Andhra Pradesh
city: Vijayawada
country: India
facility: Sunrise Hospital
state: Andhra Pradesh
city: Bengaluru
country: India
facility: Lifecare Hospital and Research Centre
state: Karnataka
city: Mumbai
country: India
facility: Seth GS Medical College & KEM Hospital
state: Maharashtra
city: Pune- Maharashtra
country: India
facility: King Edward Memorial Hospital
state: Maharashtra
city: Delhi
country: India
facility: Maulana Azad Medical College
state: New Delhi
city: Chennai
country: India
facility: Madras Diabetes Research Foundation
state: Tamil Nadu
city: Dehradun
country: India
facility: Shri Mahant Indiresh Hospital
state: Uttarakhand
city: Koriyama-shi
country: Japan
facility: Seino Internal Medicine Clinic
state: Fukushima, Japan
city: Fukuyama-shi, Hiroshima
country: Japan
facility: Nippon Kokan Fukuyama Hospital_Diabetology
city: Hokkaido
country: Japan
facility: Sasaki Internal Medicine
city: Ibaraki,
country: Japan
facility: Nishiyamado Keiwa Hospital
city: Mitaka-shi, Tokyo
country: Japan
facility: Kanno Naika_Internal Medicine
city: Mito-shi, Ibaraki
country: Japan
facility: Minami Akatsuka Clinic
city: Tokyo
country: Japan
facility: Tokyo-Eki Center-building Clinic
city: Tokyo
country: Japan
facility: Fukuwa Clinic
city: Bialystok
country: Poland
facility: Osteo Medic s.c. Artur Racewicz Jerzy Supronik
state: Podlaskie
city: Bialystok
country: Poland
facility: NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
state: Podlaskie
city: Bialystok
country: Poland
facility: Kresmed Sp. z o. o.
state: Podlaskie
city: Chorzow
country: Poland
facility: M2M Med. Sp. z o.o. Sp. j.
state: Slaskie
city: Chorzow
country: Poland
facility: M2M Med. Sp. z o.o. Sp. j.
city: Gdynia
country: Poland
facility: Pratia S.A.
city: Katowice
country: Poland
facility: Pratia S.A.
city: Lodz
country: Poland
facility: Gabinet Lekarski Malgorzata Saryusz-Wolska
city: Olsztyn
country: Poland
facility: Etyka Ośrodek Badań Klinicznych Tomasz Pesta S.K.A.
city: Poznan
country: Poland
facility: Gaja Poradnie Lekarskie
city: Warszawa
country: Poland
facility: Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Zabrze
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
city: Bratislava
country: Slovakia
facility: MEDISPEKTRUM s.r.o.
city: Kosice
country: Slovakia
facility: HUMAN-CARE s.r.o.
city: Kosice
country: Slovakia
facility: Univerzitna nemocnica L. Pasteura Kosice
city: Kosice
country: Slovakia
facility: Vysokospecializovany odborny ustav geriatricky sv. Lukasa v Kosiciach, n.o.
city: Roznava
country: Slovakia
facility: Tatratrial s.r.o.
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: Alcorcon
country: Spain
facility: Hospital Fundación Alcorcón
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Hospitalet de Llobregat
country: Spain
facility: Hospital de Bellvitge
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Bangkok Noi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
city: Patumwan ฺBangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
state: Bangkok
city: Chiang Mai
country: Thailand
facility: CMU - Hematology and Oncology
state: Mueang Chiang Mai
city: Klong Luang Pathum Thani
country: Thailand
facility: Thammasat University Hospital
state: Pathum Thani
city: Klong Luang
country: Thailand
facility: Thammasat University Hospital
state: Pathum Thani
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: