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COMPLETED
NCT06131372
PHASE2

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

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

626

Start Date

2024-04-01

Completion Date

2025-11-06

Last Updated

2026-09-24

Healthy Volunteers

No

Interventions

DRUG

Cagrilintide

Participants will receive Cagrilintide subcutaneously.

DRUG

Semaglutide

Participants will receive semaglutide subcutaneously.

DRUG

Placebo

Participants will receive placebo matched to cagrilintide or placebo matched to semaglutide subcutaneously.

Locations (129)

John Muir Physicians Network

Concord, California, United States

Valley Research

Fresno, 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 Foundation LLC

Miami, Florida, United States

Advent Health Translational Research Institute

Orlando, Florida, United States

Velocity Clin. Res Valparaiso

Valparaiso, Indiana, United States

Elite Research Center

Flint, Michigan, United States

Univ. of Nebraska Medical Center_Omaha

Omaha, Nebraska, United States

Albany Medical College

Albany, New York, United States

NYU Langone Nephrology Associates

Mineola, New York, United States

New York University Grossman 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 Nephrology Associates, 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 Multispeciality Group Inc

Beaver, Pennsylvania, United States

Main Street Physician's Care

Little River, South Carolina, United States

Osvaldo A. Brusco MD

Corpus Christi, Texas, United States

Southwest Houston Research Ltd

Houston, Texas, United States

Clinical Advancement Center

San Antonio, Texas, United States

Clinical Investigation Specialists Inc, Kenosha

Kenosha, Wisconsin, United States

Mautalen Salud e investigación

CABA, Buenos Aires, Argentina

Centro de Investigaciones Médicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Fundación CESIM

Santa Rosa, La Pampa Province, 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, Paraná, 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, São Paulo, Brazil

Hospital do Rim e Hipertensao Fundacao Oswaldo Ramos

São Paulo, Brazil

Centricity Research Calgary Endocrinology

Calgary, Alberta, Canada

Centricity Research Brampton Endocrinology

Brampton, Ontario, Canada

Centricity Research Vaughn Endocrinology

Concord, Ontario, Canada

Centricity Research Etobicoke Endocrinology

Etobicoke, Ontario, Canada

Hamilton Medical Research Group

Hamilton, Ontario, Canada

Bluewater Clin Res Group Inc

Sarnia, Ontario, Canada

UHN-Toronto General Hospital

Toronto, Ontario, Canada

Ctr de recherche Clinique de Laval

Laval, Quebec, Canada

Centre Medical Acadie

Montreal, Quebec, Canada

Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu

Le Creusot, France

Hôpitaux Saint-Joseph & Marie-Lannelongue

Paris, France

Centre Hospitalier Universitaire de Poitiers

Poitiers, France

Chu de Reims-Hopital Maison Blanche

Reims, France

Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec

Saint-Herblain, France

Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil

Toulouse, France

Centre de Recherche Clinique Portes Du Sud

Vénissieux, France

University General Hospital Of Heraklion

Heraklion, Crete, Greece

"Laiko" General Hospital of Athens

Athens, Greece

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

"Laiko" General Hospital of Athens

Athens, Greece

Gen Hospital of Athens Laiko,1st Dpt. of Propaedeutic Inter

Athens, Greece

General hospital of Athens 'G.Gennimatas'

Athens, Greece

General Hospital of Lamia

Lamia, Greece

Univ Gen Hospital Larisa

Larissa, Greece

Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease

Larissa, Greece

General University Hospital of Patras,Nephrology clinic

Pátrai, 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

General Hospital of Thessaloniki 'G. Gennimatas

Thessaloniki, Greece

"Ippokrateio" G.H. of Thessaloniki

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 county, Hungary

Belinus Bt.

Debrecen, Hajdú-Bihar, Hungary

Siófoki Kórház, Diabetológiai Szakrendelés

Siófok, Somogy County, Hungary

Borbánya Praxis E.Ü. Kft.

Nyíregyháza, Szabolcs-Szatmar Varmegye, Hungary

Szent Margit Rendelőintézet Nonprofit Kft.

Budapest, Hungary

Békés Megyei Központi Kórház

Gyula, Hungary

Endolife Specialty Hospitals

Guntur, Andhra Pradesh, India

NIZAM'S Institute of Medical Sciences

Hyderabad, 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_Internal medicine

Koriyama-shi, Fukushima, Fukushima, Japan, Japan

Nippon Kokan Fukuyama Hospital_Diabetology

Fukuyama-shi, Hiroshima, Japan

Sasaki Internal Medicine

Hokkaido, Japan

Nishiyamado Keiwa Hospital_Internal Medicine

Ibaraki, Japan

Kanno Naika_Internal Medicine

Mitaka-shi, Tokyo, Japan

Minami Akatsuka Clinic_internal medicine

Mito-shi, Ibaraki, Japan

Minami Akatsuka Clinic

Mito-shi, Ibaraki, Japan

Tokyo-Eki Center-building Clinic_Internal Medicine

Tokyo, Japan

Fukuwa Clinic_Internal Medicine

Tokyo, Japan

Fukuwa Clinic

Tokyo, Japan

Osteo Medic s.c. Artur Racewicz Jerzy Supronik

Bialystok, Podlaskie Voivodeship, Poland

NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska

Bialystok, Podlaskie Voivodeship, Poland

Kresmed Sp. z o. o.

Bialystok, Podlaskie Voivodeship, Poland

M2M Med. Badania Sp. z o.o.

Chorzów, Silesian Voivodeship, Poland

M2M Med. Sp. z o.o. Sp. j.

Chorzów, Poland

Pratia S.A.

Gdynia, Poland

Pratia S.A.

Katowice, Poland

Gabinet Lekarski Malgorzata Saryusz-Wolska

Lodz, Poland

Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.

Olsztyn, Poland

Maciej Wiza Gaja Poradnie Lekarskie

Poznan, Poland

Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji

Warsaw, Poland

Centrum Medyczne Oporow

Wroclaw, Poland

Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko

Zabrze, Poland

KARDIO-SANUS, spol. s r.o.

Bratislava, Slovakia

MEDISPEKTRUM s.r.o.

Bratislava, Slovakia

HUMAN-CARE, s.r.o.

Košice, Slovakia

Univerzitna nemocnica L. Pasteura Kosice

Košice, Slovakia

Vysokospecializovany odborny ustav geriatricky sv. Lukasa v Kosiciach, n.o.

Košice, Slovakia

Tatratrial s.r.o.

Rožňava, Slovakia

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Spain

Hospital Fundación Alcorcón

Alcorcón, Spain

Hospital Vall d'Hebron

Barcelona, Spain

Hospital de Bellvitge

L'Hospitalet de Llobregat, Spain

Hospital Gregorio Marañón

Madrid, Spain

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Siriraj Hospital

Bangkok Noi, Bangkok, Thailand

Thammasat University Hospital

Klong Luang, Changwat Pathum Thani, Thailand

Maharaj Nakorn Chiang Mai Hospital_Nephrology

Chiang Mai, Mueang Chiang Mai, Thailand

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Phramongkutklao Hospital

Bangkok, Thailand

Siriraj Hospital

Bangkok, Thailand

Thammasat Hospital_CRC

Pathum Thani, Thailand