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AzTrials

Chronic Kidney DiseasePhase 2NCT06131372

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

A Phase 2 study testing Cagrilintide and Semaglutide in people with Chronic Kidney Disease and Type 2 Diabetes, run by Novo Nordisk A/S at 129 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Kidney Disease, Type 2 Diabetes, Obesity
What is being tested?
Cagrilintide and Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
626 participants
Where
129 sitesin 13 countries
Study dates
1 Apr 2024to 6 Nov 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

129 sites in 13 countries.

129 sites in 13 countries

United States25 sites

  • Albany Medical College

    Albany, New York, 12203

  • Heritage Valley Multispeciality Group Inc

    Beaver, Pennsylvania, 15009

  • John Muir Physicians Network

    Concord, California, 94520

  • Osvaldo A. Brusco MD

    Corpus Christi, Texas, 78414

  • Northeast Research Institute

    Fleming Island, Florida, 32003

  • Elite Research Center

    Flint, Michigan, 48532

  • Valley Research

    Fresno, California, 93720

  • Southwest Houston Research Ltd

    Houston, Texas, 77099

  • Clinical Investigation Specialists Inc, Kenosha

    Kenosha, Wisconsin, 53144

  • Main Street Physician's Care

    Little River, South Carolina, 29566

  • Ohio- Advanced Medical Research

    Maumee, Ohio, 43537

  • Life Spring Research Foundation LLC

    Miami, Florida, 33130

  • NYU Langone Nephrology Associates

    Mineola, New York, 11501

  • Carteret Medical Group

    Morehead City, North Carolina, 28557

  • Eastern Nephrology Associates, PLLC

    New Bern, North Carolina, 28562

  • New York University Grossman School of Medicine

    New York, New York, 10016

  • Univ. of Nebraska Medical Center_Omaha

    Omaha, Nebraska, 68198

  • Advent Health Translational Research Institute

    Orlando, Florida, 32804

  • Desert Oasis Hlthcr Med Group

    Palm Springs, California, 92262

  • Clinical Advancement Center

    San Antonio, Texas, 78212

  • North America Research Institute

    San Dimas, California, 91773

  • NorCal Endocrinology and Internal Medicine

    San Ramon, California, 94583

  • Velocity Clin. Res Valparaiso

    Valparaiso, Indiana, 46383

  • Southgate Medical Group, LLP

    West Seneca, New York, 14224

  • Brookview Hills Research Associates, LLC

    Winston-Salem, North Carolina, 27103

Other trials in United States

Greece20 sites

  • "Laiko" General Hospital of Athens

    Athens, 11527

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

    Athens, 11527

  • General hospital of Athens 'G.Gennimatas'

    Athens, 11527

  • Iatriko Athinon 'Palaiou Falirou'

    Athens, 17562

  • "Laiko" General Hospital of Athens

    Athens, GR-11527

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

    Athens, GR-11527

  • General hospital of Athens 'G.Gennimatas'

    Athens, GR-11527

  • University General Hospital Of Heraklion

    Heraklion, Crete, 71500

  • General Hospital of Lamia

    Lamia, 35100

  • Univ Gen Hospital Larisa

    Larissa, 41110

  • Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease

    Larissa, GR-41110

  • General University Hospital of Patras,Nephrology clinic

    Pátrai, GR-26504

  • General University Hospital of Patras,Nephrology clinic

    Rio, Patra, 26504

  • General Hospital of Thessaloniki 'G. Gennimatas

    Thessaloniki, 54635

  • "Ippokrateio" G.H. of Thessaloniki

    Thessaloniki, 54642

  • General Hospital of Thessaloniki "Ippokrateio"

    Thessaloniki, 54642

  • General Hospital of Thessaloniki "G.Papanikolaou"

    Thessaloniki, 57010

  • General Hospital of Thessaloniki 'G. Gennimatas

    Thessaloniki, GR-54635

  • "Ippokrateio" G.H. of Thessaloniki

    Thessaloniki, GR-54642

  • General Hospital of Thessaloniki "G.Papanikolaou"

    Thessaloniki, GR-57010

Other trials in Greece

Poland13 sites

  • Osteo Medic s.c. Artur Racewicz Jerzy Supronik

    Bialystok, Podlaskie Voivodeship, 15-351

  • NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska

    Bialystok, Podlaskie Voivodeship, 15-435

  • Kresmed Sp. z o. o.

    Bialystok, Podlaskie Voivodeship, 15-481

  • M2M Med. Badania Sp. z o.o.

    Chorzów, Silesian Voivodeship, 41-500

  • M2M Med. Sp. z o.o. Sp. j.

    Chorzów, 41-500

  • Pratia S.A.

    Gdynia, 81-338

  • Pratia S.A.

    Katowice, 40-081

  • Gabinet Lekarski Malgorzata Saryusz-Wolska

    Lodz, 90-132

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

    Olsztyn, 10-117

  • Maciej Wiza Gaja Poradnie Lekarskie

    Poznan, 61-251

  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji

    Warsaw, 02-507

  • Centrum Medyczne Oporow

    Wroclaw, 52-416

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko

    Zabrze, 41-800

Other trials in Poland

Japan10 sites

  • Nippon Kokan Fukuyama Hospital_Diabetology

    Fukuyama-shi, Hiroshima, 721-0927

  • Sasaki Internal Medicine

    Hokkaido, 062-0007

  • Nishiyamado Keiwa Hospital_Internal Medicine

    Ibaraki, 331-0133

  • Seino Internal Medicine Clinic_Internal medicine

    Koriyama-shi, Fukushima, Fukushima, Japan, 963-8851

  • Kanno Naika_Internal Medicine

    Mitaka-shi, Tokyo, 181-0013

  • Minami Akatsuka Clinic_internal medicine

    Mito-shi, Ibaraki, 311-4153

  • Minami Akatsuka Clinic

    Mito-shi, Ibaraki, 311-4153

  • Tokyo-Eki Center-building Clinic_Internal Medicine

    Tokyo, 103-0027

  • Fukuwa Clinic_Internal Medicine

    Tokyo, 104-0031

  • Fukuwa Clinic

    Tokyo, 104-0031

Other trials in Japan

Canada9 sites

  • Centricity Research Brampton Endocrinology

    Brampton, Ontario, L6S 0C6

  • Centricity Research Calgary Endocrinology

    Calgary, Alberta, T2H 2G4

  • Centricity Research Vaughn Endocrinology

    Concord, Ontario, L4K 4M2

  • Centricity Research Etobicoke Endocrinology

    Etobicoke, Ontario, M9R 4E1

  • Hamilton Medical Research Group

    Hamilton, Ontario, L8L 5G4

  • Ctr de recherche Clinique de Laval

    Laval, Quebec, H7T 2P5

  • Centre Medical Acadie

    Montreal, Quebec, H4N 2W2

  • Bluewater Clin Res Group Inc

    Sarnia, Ontario, N7T 4X3

  • UHN-Toronto General Hospital

    Toronto, Ontario, M5G 2N2

Other trials in Canada

India9 sites

  • Lifecare Hospital and Research Centre

    Bengaluru, Karnataka, 560066

  • Madras Diabetes Research Foundation

    Chennai, Tamil Nadu, 600086

  • Shri Mahant Indiresh Hospital

    Dehradun, Uttarakhand, 248001

  • Maulana Azad Medical College

    Delhi, New Delhi, 110002

  • Endolife Specialty Hospitals

    Guntur, Andhra Pradesh, 522001

  • NIZAM'S Institute of Medical Sciences

    Hyderabad, Andhra Pradesh, 500082

  • Seth GS Medical College & KEM Hospital

    Mumbai, Maharashtra, 400012

  • King Edward Memorial Hospital

    Pune- Maharashtra, Maharashtra, 411011

  • Sunrise Hospital

    Vijayawada, Andhra Pradesh, 520002

Other trials in India

France7 sites

  • Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu

    Le Creusot, 71200

  • Hôpitaux Saint-Joseph & Marie-Lannelongue

    Paris, 75674

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86000

  • Chu de Reims-Hopital Maison Blanche

    Reims, 51092

  • Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec

    Saint-Herblain, 44800

  • Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil

    Toulouse, 31059

  • Centre de Recherche Clinique Portes Du Sud

    Vénissieux, 69200

Other trials in France

Hungary7 sites

  • Lausmed Kft.

    Baja, Bács-Kiskun county, 6500

  • Szent Margit Rendelőintézet Nonprofit Kft.

    Budapest, 1032

  • Belinus Bt.

    Debrecen, Hajdú-Bihar, 4025

  • Békés Megyei Központi Kórház

    Gyula, 5700

  • Borbánya Praxis E.Ü. Kft.

    Nyíregyháza, Szabolcs-Szatmar Varmegye, 4405

  • PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum

    Pécs, Baranya Vármegye, 7623

  • Siófoki Kórház, Diabetológiai Szakrendelés

    Siófok, Somogy County, 8600

Other trials in Hungary

Spain7 sites

  • Hospital Fundación Alcorcón

    Alcorcón, 28922

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital de Bellvitge

    L'Hospitalet de Llobregat, 08907

  • Hospital Gregorio Marañón

    Madrid, 28007

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, 38320

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

Thailand7 sites

  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330

  • Phramongkutklao Hospital

    Bangkok, 10400

  • Siriraj Hospital

    Bangkok, 10700

  • Siriraj Hospital

    Bangkok Noi, Bangkok, 10700

  • Maharaj Nakorn Chiang Mai Hospital_Nephrology

    Chiang Mai, Mueang Chiang Mai, 50200

  • Thammasat University Hospital

    Klong Luang, Changwat Pathum Thani, 12120

  • Thammasat Hospital_CRC

    Pathum Thani, 12120

Other trials in Thailand

Slovakia6 sites

  • KARDIO-SANUS, spol. s r.o.

    Bratislava, 84108

  • MEDISPEKTRUM s.r.o.

    Bratislava, 851 01

  • HUMAN-CARE, s.r.o.

    Košice, 040 01

  • Univerzitna nemocnica L. Pasteura Kosice

    Košice, 040 01

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

    Košice, 040 01

  • Tatratrial s.r.o.

    Rožňava, 048 01

Other trials in Slovakia

Argentina5 sites

  • Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli

    Buenos Aires, C1425AGC

  • Mautalen Salud e investigación

    CABA, Buenos Aires, C1128 AAF

  • Centro Médico Privado San Vicente Diabetes

    Córdoba, X5006IKK

  • Centro de Investigaciones Médicas Mar del Plata

    Mar del Plata, Buenos Aires, B7600GNY

  • Fundación CESIM

    Santa Rosa, La Pampa Province, 6300

Other trials in Argentina

Brazil4 sites

  • Instituto Pró-Renal Brasil

    Curitiba, Paraná, 80440-020

  • Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.

    Porto Alegre, Rio Grande do Sul, 90430-001

  • CPCLIN - Centro de Pesquisas Clínicas

    São Paulo, São Paulo, 01228-200

  • Hospital do Rim e Hipertensao Fundacao Oswaldo Ramos

    São Paulo, 04038-002

Other trials in Brazil

About this study

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

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.

Being tested
Cagrilintide, Semaglutide, Placebo
Medical subject headings
Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CagrilintideDrug

    Participants will receive Cagrilintide subcutaneously.

  • SemaglutideDrug

    Participants will receive semaglutide subcutaneously.

  • PlaceboDrug

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

Study groups in NCT06131372
Study groupRoleWhat they receive
CagriSemaExperimentalParticipants will receive cagrilintide and semaglutide subcutaneously once-weekly after a dose escalation period of 16 weeks during the maintenance period for 10 weeks.
Receives: Drug: Cagrilintide; Drug: Semaglutide
SemaglutideExperimentalParticipants 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.
Receives: Drug: Semaglutide; Drug: Placebo
CagrilintideExperimentalParticipants 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.
Receives: Drug: Cagrilintide; Drug: Placebo
PlaceboPlacebo comparatorParticipants will receive placebo matched to cagrilintide and placebo matched to semaglutide subcutaneously once weekly for 26 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in urinary albumin-to-creatinine ratio (UACR)

    Measured in ratio to baseline.

    Measured: From baseline (week 0) to end of treatment (week 26)

Secondary outcomes (13)

  1. 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).

    Measured: From baseline (week 0) to end of treatment (week 26)

  2. Change in eGFR (creatinine-based CKD-EPI 2021)

    Measured in mL/min/1.73 m^2.

    Measured: From baseline (week 0) to end of treatment (week 26)

  3. Relative change in body weight

    Measured in percentage (%).

    Measured: From baseline (week 0) to end of treatment (week 26)

  4. Achievement of greater than or equal to (≥) 5 % weight reduction

    Count of participants.

    Measured: From baseline (week 0) to end of treatment (week 26)

  5. Achievement of ≥ 10 % weight reduction

    Count of participants.

    Measured: From baseline (week 0) to end of treatment (week 26)

  6. Change in waist circumference

    Measured in centimeter (cm).

    Measured: From baseline (week 0) to end of treatment (week 26)

  7. Change in glycated haemoglobin (HbA1c)

    Measured in %-points.

    Measured: From baseline (week 0) to end of treatment (week 26)

  8. Change in systolic blood pressure

    Measured in millimeters of mercury (mmHg).

    Measured: From baseline (week 0) to end of treatment (week 26)

  9. Change in diastolic blood pressure

    Measured in mmHg.

    Measured: From baseline (week 0) to end of treatment (week 26)

  10. Number of treatment emergent adverse events (TEAEs)

    count of events.

    Measured: From baseline (week 0) to end of study (week 32)

  11. Number of treatment emergent serious adverse events (SAEs)

    count of events.

    Measured: From baseline (week 0) to end of study (week 32)

  12. 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.

    Measured: From baseline (week 0) to end of study (week 32)

  13. 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.

    Measured: From baseline (week 0) to end of study (week 32)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2023
  2. Study start1 Apr 2024
  3. Primary completion24 Sep 2025
  4. Study completion6 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
626 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06131372
Sponsor's protocol ID
NN9388-7700
Other IDs
U1111-1291-5907, 2023-505857-42, 2023
Status last verified
Sep 2026
First submitted
9 Nov 2023
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cagrilintide and Semaglutide in people with Chronic Kidney Disease and Type 2 Diabetes, run by Novo Nordisk A/S at 129 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 sites in United States, Greece, Poland, Japan, Canada and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in urinary albumin-to-creatinine ratio (UACR) (time frame: From baseline (week 0) to end of treatment (week 26)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06131372.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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