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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06131372
• Other study ID #: NN9388-7700
• Secondary ID: U1111-1291-59072
• Status: Recruiting
• Phase: Phase 2
• Start date: March 29, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 618
• Est. completion date: December 1, 2025
• Est. primary completion date: October 13, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Kidney Diseases
• Obesity
• Overweight
• Renal Insufficiency, Chronic
• Type 2 Diabetes

Intervention

Drug:
• Cagrilintide
Participants will receive Cagrilintide subcutaneously.
• Semaglutide
Participants will receive semaglutide subcutaneously.
• Placebo
Participants will receive placebo matched to cagrilintide or placebo matched to semaglutide subcutaneously.

Locations

Country	Name	City	State
Argentina	Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli	Buenos Aires
Argentina	Mautalen Salud e investigación	Caba	Buenos Aires
Argentina	Centro Médico Privado San Vicente Diabetes	Córdoba
Argentina	Centro de Investigaciones Médicas Clínica de Fracturas y Or	Mar del Plata	Buenos Aires
Argentina	Fundación CESIM	Santa Rosa	La Pampa
Brazil	Instituto Pró-Renal Brasil	Curitiba	Parana
Brazil	Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital do Rim e Hipertensao Fundacao Oswaldo Ramos	Sao Paulo
Brazil	CPCLIN - Centro de Pesquisas Clínicas	São Paulo	Sao Paulo
Canada	Centricity Research Calgary	Calgary	Alberta
Canada	Centricity Research Vaughn	Concord	Ontario
Canada	Hamilton Medical Rsrch Grp	Hamilton	Ontario
Canada	Ctr de rech Clin de Laval	Laval	Quebec
Canada	Centre Medical Acadie	Montreal	Quebec
Canada	Bluewater Clin Res Group Inc	Sarnia	Ontario
Canada	UHN-Toronto General Hospital	Toronto	Ontario
France	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
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	General Hospital of Lamia	Lamia
Greece	Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease	Larissa
Greece	General University Hospital of Patras,Nephrology clinic	Patra
Greece	General University Hospital of Patras,Nephrology clinic	Rio, Patra
Greece	"Ippokrateio" G.H. of Thessaloniki	Thessaloniki
Greece	General Hospital of Thessaloniki "G.Papanikolaou"	Thessaloniki
Greece	General Hospital of Thessaloniki 'G. Gennimatas	Thessaloniki
Hungary	Lausmed Kft.	Baja	Bács-Kiskun Vármegye
Hungary	Szent Margit Rendelointézet Nonprofit Kft.	Budapest
Hungary	Belinus Bt.	Debrecen	Hajdu-Bihar Varmegye
Hungary	Békés Megyei Központi Kórház	Gyula
Hungary	Borbánya Praxis E.Ü. Kft.	Nyíregyháza	Szabolcs-Szatmar Varmegye
Hungary	PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum	Pécs	Baranya Vármegye
Hungary	Siófoki Kórház, Diabetológiai Szakrendelés	Siófok	Somogy Vármegye
India	Lifecare Hospital and Research Centre	Bengaluru	Karnataka
India	Madras Diabetes Research Foundation	Chennai	Tamil Nadu
India	Shri Mahant Indiresh Hospital	Dehradun	Uttarakhand
India	Maulana Azad Medical College	Delhi	New Delhi
India	Endolife Specialty Hospitals	Guntur	Andhra Pradesh
India	Seth GS Medical College & KEM Hospital	Mumbai	Maharashtra
India	King Edward Memorial Hospital	Pune- Maharashtra	Maharashtra
Japan	Nippon Kokan Fukuyama Hospital_Diabetology	Fukuyama-shi, Hiroshima
Japan	Nishiyamado Keiwa Hospital	Ibaraki,
Japan	Seino Internal Medicine Clinic	Koriyama-shi	Fukushima, Japan
Japan	Kanno Naika_Internal Medicine	Mitaka-shi, Tokyo
Japan	Minami Akatsuka Clinic	Mito-shi, Ibaraki
Japan	Fukuwa Clinic	Tokyo
Japan	Fukuwa Clinic	Tokyo
Japan	Tokyo-Eki Center-building Clinic	Tokyo
Poland	Kresmed Sp. z o. o.	Bialystok	Podlaskie
Poland	Osteo Medic s.c. Artur Racewicz Jerzy Supronik	Bialystok	Podlaskie
Poland	Pratia S.A.	Gdynia
Poland	M2M Med. Sp. z o.o. Sp. j.	Katowice
Poland	M2M Med. Sp. z o.o. Sp. j.	Katowice
Poland	Pratia S.A.	Katowice
Poland	Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.	Olsztyn
Poland	Gaja Poradnie Lekarskie	Poznan
Poland	Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji	Warszawa
Poland	Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji	Warszawa
Poland	Centrum Medyczne Oporow	Wroclaw
Slovakia	MEDISPEKTRUM s.r.o.	Bratislava
Slovakia	HUMAN-CARE s.r.o.	Kosice
Slovakia	Univerzitna nemocnica L. Pasteura Kosice	Kosice
Slovakia	Vysokospecializovany odborny ustav geriatricky sv. Lukasa v Kosiciach, n.o.	Kosice
Slovakia	Tatratrial s.r.o.	Roznava
Spain	Hospital Fundación Alcorcón	Alcorcon
Spain	Hospital de Bellvitge	Hospitalet de Llobregat
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda	Madrid
Spain	Hospital Universitario de Canarias	Santa Cruz de Tenerife
Spain	Hospital Clínico Universitario de Valencia	Valencia
Thailand	Phramongkutklao Hospital	Bangkok
Thailand	Siriraj Hospital	Bangkok
Thailand	Siriraj Hospital	Bangkok Noi	Bangkok
Thailand	Maharaj Nakorn Chiang Mai Hospital	Chiang Mai	Mueang Chiang Mai District
Thailand	Thammasat University Hospital	Klong Luang	Pathum Thani
Thailand	King Chulalongkorn Memorial Hospital	Patumwan	Bangkok
United States	Albany Medical College	Albany	New York
United States	Heritage Valley Medical Group Inc	Beaver	Pennsylvania
United States	John Muir Physician Network	Concord	California
United States	Osvaldo A. Brusco MD PA	Corpus Christi	Texas
United States	Northeast Research Institute	Fleming Island	Florida
United States	Elite Research Center	Flint	Michigan
United States	Valley Research	Fresno	California
United States	Southwest Houston Research Ltd	Houston	Texas
United States	Clinical Inv Spec, Inc.Kenosha	Kenosha	Wisconsin
United States	Main Street Physician's Care	Little River	South Carolina
United States	Ohio- Advanced Medical Research	Maumee	Ohio
United States	NYU Langone Neph Associates	Mineola	New York
United States	Carteret Medical Group	Morehead City	North Carolina
United States	New York University School of Medicine	New York	New York
United States	Univ. of Nebraska Medical Center_Omaha	Omaha	Nebraska
United States	Florida Hospital Translational Research Institute	Orlando	Florida
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	Velocity Clin. Res Valparaiso	Valparaiso	Indiana
United States	Southgate Medical Group, LLP	West Seneca	New York
United States	Brookview Hills Research Associates, LLC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  France,  Greece,  Hungary,  India,  Japan,  Poland,  Slovakia,  Spain,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in urinary albumin-to-creatinine ratio (UACR)	Measured in ratio to baseline.	From baseline (week 0) to end of treatment (week 26)
Secondary	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)
Secondary	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)
Secondary	Relative change in body weight	Measured in percentage (%).	From baseline (week 0) to end of treatment (week 26)
Secondary	Achievement of greater than or equal to (=) 5 % weight reduction	Count of participants.	From baseline (week 0) to end of treatment (week 26)
Secondary	Achievement of = 10 % weight reduction	Count of participants.	From baseline (week 0) to end of treatment (week 26)
Secondary	Change in waist circumference	Measured in centimeter (cm).	From baseline (week 0) to end of treatment (week 26)
Secondary	Change in glycated haemoglobin (HbA1c)	Measured in %-points.	From baseline (week 0) to end of treatment (week 26)
Secondary	Change in systolic blood pressure	Measured in millimeters of mercury (mmHg).	From baseline (week 0) to end of treatment (week 26)
Secondary	Change in diastolic blood pressure	Measured in mmHg.	From baseline (week 0) to end of treatment (week 26)
Secondary	Number of treatment emergent adverse events (TEAEs)	count of events.	From baseline (week 0) to end of study (week 32)
Secondary	Number of treatment emergent serious adverse events (SAEs)	count of events.	From baseline (week 0) to end of study (week 32)
Secondary	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)
Secondary	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)