A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both

NCT06534411 | Active Not Recruiting Phase 3 FDA Drug

• 3 other identifiers: NN9388-7741U1111-1300-25902023-509600-15
• Study Type: interventional
• Target: 1,023
• Locations: 14 countries
• Sites: 163

Brief Summary

This study will look at how much CagriSema lowers blood sugar and body weight in people with type 2 diabetes. CagriSema is a new investigational medicine. Doctors cannot yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide. Doctors can prescribe tirzepatide in some countries. Participants will either receive CagriSema or tirzepatide. Which treatment the participant will receive is decided by chance. For each participant, the study will last for up to 1 year and 4 months.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Change in Glycated Haemoglobin (HbA1c)

  Measured in percentage points.

  From baseline (week 0) to end of treatment (week 60)

• Relative Change in Body Weight

  Measured in percentage (%).

  From baseline (week 0) to end of treatment (week 60)

Secondary Outcomes (25)

• Change in HbA1c

  From baseline (week 0) to end of treatment (week 60)

• Change in Fasting Plasma Glucose (FPG)

  From baseline (week 0) to end of treatment (week 60)

• Number of Participants Who Achieve HbA1c Target Values of Less Than (<) 7.0 (Percent [%]) (< 53 millimole per mole [mmol/mol])

  At end of treatment (week 60)

• Number of Participants Who Achieve HbA1c Target Values of Less Than or Equal to (<=) 6.5% (<= 48 mmol/mol)

  At end of treatment (week 60)

• Number of Participants Who Achieve Greater Than or Equal to (>=) 5% Weight Reduction

  From baseline (week 0) to end of treatment (week 60)

Study Arms (2)

CagriSema

EXPERIMENTAL

Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every 4 weeks in a 8-week dose escalation period until target dose of CagriSema is achieved and maintained for 52 weeks.

Drug: Cagrilintide; Drug: Semaglutide

Tirzepatide

EXPERIMENTAL

Participants will receive once-weekly s.c injections of tirzepatide at escalating dose in a 4-week dose escalating period and maintained up to 56 weeks.

Drug: Tirzepatide

Interventions

Cagrilintide DRUG

Participants will receive once-weekly cagrilintide subcutaneously.

CagriSema

Semaglutide DRUG

Participants will receive once-weekly semaglutide subcutaneously.

CagriSema

Tirzepatide DRUG

Participants will receive once-weekly tirzepatide subcutaneously.

Tirzepatide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female (sex at birth).
• Age 18 years or above at the time of signing the informed consent.
• Diagnosed with type 2 diabetes mellitus greater than or equal to (\>=) 180 days before screening.
• Stable daily dose(s) \>= 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator:
• Metformin
• sodium-glucose co-transporter 2 inhibitor (SGLT2i)
• Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mol \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening.
• Body mass index (BMI) \>= 30 kilogram per square meter (kg/m\^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.

You may not qualify if:

• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
• Renal impairment with estimated Glomerular Filtration Rate less than \< 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) as determined by central laboratory at 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (163)

Cahaba Research

Pelham, Alabama, 35124, United States

Location

Velocity Clinical Research-Phoenix

Phoenix, Arizona, 85006, United States

Location

AES Tucson DRS

Tucson, Arizona, 85712, United States

Location

Woodland Int. Research Group

Little Rock, Arkansas, 72211, United States

Location

Velocity Clin Res-Chula Vista

Chula Vista, California, 91911, United States

Location

John Muir Physicians Network

Concord, California, 94520, United States

Location

Diabetes & Endocrine Specialists - La Mesa

La Mesa, California, 91942, United States

Location

Velocity Clin Research LA

Los Angeles, California, 90017, United States

Location

Desert Oasis Healthcare

Palm Springs, California, 92262, United States

Location

Velocity Clin Res Santa Ana

Santa Ana, California, 92704, United States

Location

Velocity Clin Res - Panorama

Van Nuys, California, 91405, United States

Location

Optumcare Clinical Trials,LLC-Golden

Colorado Springs, Colorado, 80906, United States

Location

FEME Medical LLC

Washington D.C., District of Columbia, 20010, United States

Location

Tampa Bay Medical Research

Clearwater, Florida, 33761, United States

Location

AGA Clinical Trial

Hialeah, Florida, 33012, United States

Location

Bioclinical Research Alliance

Miami, Florida, 33155, United States

Location

New Horizon Research Center

Miami, Florida, 33165, United States

Location

South Broward Research LLC

Miramar, Florida, 33027, United States

Location

West Orange Endocrinology

Ocoee, Florida, 34761, United States

Location

Optimal Research Sites

Orange City, Florida, 32763, United States

Location

Center for Diab,Obes & Metab

Pembroke Pines, Florida, 33024, United States

Location

Javara Inc. / Privia Medical Group Georgia LLC

Fayetteville, Georgia, 30214, United States

Location

Clinical Invest Special_Gurnee

Gurnee, Illinois, 60031, United States

Location

Iowa Diabetes & Endo Res Ctr

West Des Moines, Iowa, 50266, United States

Location

Cotton-Oneill Diabetes and End

Topeka, Kansas, 66606-2806, United States

Location

AES Minneapolis DRS

Richfield, Minnesota, 55423, United States

Location

Velocity Clin Res Gulfport

Gulfport, Mississippi, 39503, United States

Location

AES St. Louis DRS

St Louis, Missouri, 63141, United States

Location

Univ of Nebraska Medical CTR

Omaha, Nebraska, 68198-3020, United States

Location

Velocity Clin Res Albuquerque

Albuquerque, New Mexico, 87107, United States

Location

Albany Medical College

Albany, New York, 12203, United States

Location

Carteret Medical Group

Morehead City, North Carolina, 28557, United States

Location

Piedmont Healthcare/Research

Statesville, North Carolina, 28625, United States

Location

Lillestol Research LLC

Fargo, North Dakota, 58104, United States

Location

Triad Research Institute

Norman, Oklahoma, 73072, United States

Location

Circuit Clinical - PMSI

Pottstown, Pennsylvania, 19464, United States

Location

Clinical Res Collaborative

Cumberland, Rhode Island, 02864, United States

Location

Velocity Clin Res Providence

East Greenwich, Rhode Island, 02818, United States

Location

Velocity Clin Res Gaffney

Gaffney, South Carolina, 29340, United States

Location

Holston Medical Group

Kingsport, Tennessee, 37660, United States

Location

Clinical Research Associates

Nashville, Tennessee, 37203, United States

Location

Velocity Clin Res Austin

Austin, Texas, 78759, United States

Location

AES Dallas DFW DRS

Dallas, Texas, 75234, United States

Location

UT Southwestern Medical Center - Lingvay

Dallas, Texas, 75390, United States

Location

JCCT- Juno NW Houston

Houston, Texas, 77040, United States

Location

Discovery MM Services - Houston - Broadway Street

Houston, Texas, 77061, United States

Location

PlanIt Research, PLLC

Houston, Texas, 77079, United States

Location

Sante Clinical Research

Kerrville, Texas, 78028, United States

Location

Aeres Clinical Research

Laredo, Texas, 78041, United States

Location

RGV Endocrine Center

McAllen, Texas, 78503, United States

Location

Privia Health Javara Clin Res.

Stephenville, Texas, 76401, United States

Location

J.Lewis Research Inc

Salt Lake City, Utah, 84109, United States

Location

Chrysalis Clinical Research

St. George, Utah, 84790, United States

Location

TPMG Clinical Research

Newport News, Virginia, 23606, United States

Location

Centro Médico CIMEL

Lanús Este, Buenos Aires, B1824KAJ, Argentina

Location

Centro de Investigaciones Médicas Mar del Plata

Mar del Plata, Buenos Aires, B7600GNY, Argentina

Location

Fundación CESIM

Santa Rosa, La Pampa Province, 6300, Argentina

Location

Centro de Investigaciones Médicas Tucumán

San Miguel de Tucuimán, Tucumán Province, 4000, Argentina

Location

IMOBA

City of Buenos Aires, C1056ABH, Argentina

Location

Centro de Investigaciones Metabólicas

City of Buenos Aires, C1056ABI, Argentina

Location

Instituto de Investigaciones Clinicas San Nicolás

San Nicolás, B2900, Argentina

Location

Paratus Clinical

Bruce, Australian Capital Territory, 2617, Australia

Location

Hunter Diabetes Centre

Merewether, New South Wales, 2291, Australia

Location

Austrials

St Leonards, New South Wales, 2065, Australia

Location

Momentum Clinical Research St Leonards

St Leonards, New South Wales, 2065, Australia

Location

Roger Chih Yu Chen

Sydney, New South Wales, 2148, Australia

Location

Townsville University Hospital

Douglas, Queensland, 4814, Australia

Location

Paratus Clinical

Herston, Queensland, 4006, Australia

Location

Centro de Diabetes Curitiba

Curitiba, Paraná, 80810-040, Brazil

Location

Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.

Porto Alegre, Rio Grande do Sul, 90430-001, Brazil

Location

CPQuali Pesquisa Clínica Ltda

São Paulo, São Paulo, 01228-000, Brazil

Location

Hilltop Medical Clinic

Surrey, British Columbia, V4A 0C1, Canada

Location

G.A. Research Associates Ltd.

Moncton, New Brunswick, E1G 1A7, Canada

Location

Centricity Research Brampton Endocrinology

Brampton, Ontario, L6S 0C6, Canada

Location

Centricity Research Etobicoke Endocrinology

Etobicoke, Ontario, M9R 4E1, Canada

Location

Wharton Medical Clinic Clinical Trials (Hamilton)

Hamilton, Ontario, L8L 5G8, Canada

Location

London Road Diagnostic Clinic and Medical Centre

Sarnia, Ontario, N7T 4X3, Canada

Location

Diabetes Heart Research Centre

Toronto, Ontario, M6G 1M2, Canada

Location

Ctr de recherche Clinique de Laval

Laval, Quebec, H7T 2P5, Canada

Location

Alpha Recherche Clinique - Clinique de Levis

Lévis, Quebec, G6V 0C9, Canada

Location

Centre Medical Acadie

Montreal, Quebec, H4N 2W2, Canada

Location

Ctr de Med Metab de Lanaudiere

Terrebonne, Quebec, J6X 4P7, Canada

Location

Diex Recherche Victoriaville

Victoriaville, Quebec, G6P 3Z8, Canada

Location

Centre de Recherche Saint-Louis

Québec, G1W 4R4, Canada

Location

Herz- und Diabeteszentrum NRW - Bad Oeynhausen

Bad Oeynhausen, 32545, Germany

Location

Universitätsklinikum Essen - Klinik für Endokrinologie, Diabetologie und Stoffwechsel

Essen, 45147, Germany

Location

Praxis am Markt Dr. Becker

Essen, 45355, Germany

Location

Universitätsklinikum Freiburg - Innere Medizin II

Freiburg im Breisgau, 79106, Germany

Location

Wendisch - Dahl Hamburg - DZHW

Hamburg, 22607, Germany

Location

Medicover Neuroendokrinologie MVZ München

München, 81667, Germany

Location

MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin

Münster, 48153, Germany

Location

Zentrum für klinische Studien Allgäu Oberschwaben

Wangen, 88239, Germany

Location

Alexandra General Hospital, Therapeutic Clinic

Athens, Attica, 11528, Greece

Location

General Hospital Venizeleio-Pananeio - Diabetic Clinic

Heraklion, Crete, 71409, Greece

Location

Evangelismos Hospital

Athens, 10676, Greece

Location

Iatriko Athinon 'Palaiou Falirou'

Athens, 17562, Greece

Location

"Laiko" General Hospital of Athens

Goudi/Athens, 11527, Greece

Location

University General Hospital of Ioannina,Internal Medicine

Ioannina, 45500, Greece

Location

General Hospital of Thessaloniki 'G. Gennimatas

Thessaloniki, 54635, Greece

Location

'Ippokrateio' General Hospital of Thessaloniki

Thessaloniki, 54642, Greece

Location

Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ

Szeged, Csongrád-Csanád, 6725, Hungary

Location

Komáromi Selye János Kórház

Komárom, Komárom-Esztergom, 2900, Hungary

Location

Óbudai Egészségügyi Centrum

Budapest, Pest County, 1036, Hungary

Location

QUALICLINIC Egészségügyi Szolgáltató és Kutatásszervező Kft

Budapest, Pest County, 1134, Hungary

Location

Szőcs Depot Egészségügyi Szolgáltató Kft.

Budapest, 1042, Hungary

Location

Semmelweis Egyetem

Budapest, 1083, Hungary

Location

ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.

Budapest, 1089, Hungary

Location

PVN Kutató Kft.

Budapest, 1102, Hungary

Location

MED-TIMA Kft.

Budapest, 1132, Hungary

Location

Észak-Pesti Centrumkórház Honvédkórház - Diabetológia Szakrendelés

Budapest, 1134, Hungary

Location

Endolife Specialty Hospitals

Guntur, Andhra Pradesh, 522001, India

Location

Ramaiah Memorial Hospital

Bengaluru, Karnataka, 560054, India

Location

Excel Endocrine Centre

Kolhāpur, Maharashtra, 416008, India

Location

Acharya Vinoba Bhave Rural Hospital, Sawangi Meghe, Wardha

Wardha, Maharashtra, 442001, India

Location

All India Institute of Medical Sciences (AIIMS)

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Jawahar Lal Nehru Govt. Medical College

Ajmer, Rajasthan, 305001, India

Location

SMS Hospital

Jaipur, Rajasthan, 302004, India

Location

Diabetes, Thyroid and Endocrine Centre

Jaipur, Rajasthan, 302006, India

Location

Arthur Asirvatham hospital,

Madurai, Tamil Nadu, 625 020, India

Location

Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)

Puducherry, Tamil Nadu, 605006, India

Location

AIG Hospitals,Hyderabad

Hyderabad, Telangana, 500032, India

Location

Udyaan Health Care

Lucknow, Uttar Pradesh, 226002, India

Location

IPGME&R and SSKM Hospital

Kolkata, West Bengal, 700020, India

Location

Clalit sick fund Herzeliya

Herzeliya, Israel, 4630945, Israel

Location

Rambam MC - Diabetes and obesity center of excellence

Haifa, 31096, Israel

Location

Wolfson MC - Diabetes Clinic

Holon, 58100, Israel

Location

Hadassah Ein Karam MC - Diabetes Unit

Jerusalem, 91120, Israel

Location

Rabin MC Beilinson - Endo unit

Petah Tikva, 49100, Israel

Location

Sourasky MC - Institute of Endocrinology, metabolism and hypertension

Tel Aviv, 6423906, Israel

Location

Sheba MC - Endocrinology Clinic

Tel Litwinsky, 52621, Israel

Location

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Podlaskie Voivodeship, 15-276, Poland

Location

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, 15-269, Poland

Location

Diab Serwis Popenda Spółka Jawna

Chorzów, 41-516, Poland

Location

Specjalistyczny Gabinet Diabetologiczny Rumianowski Radosław

Gorzów Wielkopolski, 66-400, Poland

Location

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

Olsztyn, 10-117, Poland

Location

Kiepury Clinic MALGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POLOZNICZA

Sosnowiec, 41-209, Poland

Location

Centrum Medyczne Oporow

Wroclaw, 52-416, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko

Zabrze, 41-800, Poland

Location

Centrum Terapii Wspolczesnej - J.M. Jasnorzewska S.K.A.

Lodz, Łódź Voivodeship, 90-338, Poland

Location

Diabdana S.R.L.

Oradea, Bihor County, 410147, Romania

Location

Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila

Bucharest, Bucharest, 020475, Romania

Location

CMI Dr Pop Lavinia

Baia Mare, Maramureş, 430222, Romania

Location

Sc Mediab Srl

Târgu Mureş, Mureș County, 540142, Romania

Location

SC Nutrilife SRL

Bucharest, 013764, Romania

Location

Diabet Med SRL

Bucharest, 050913, Romania

Location

Sanamed Hospital SRL

Bucharest, 060013, Romania

Location

Clinica Korall S.R.L. Satu Mare

Satu Mare, 440055, Romania

Location

Clinica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

Centro Periferico De Especialidades Bola Azul

Almería, 04009, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario San Cecilio

Granada, 18016, Spain

Location

Clínica Nuevas Tecnologías en Diabetes y Endocrinología

Seville, 41003, Spain

Location

Hospital Clínico de Valladolid

Valladolid, 47003, Spain

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

Chang Gung Memorial Hospital - Kaohsiung Branch

Kaohsiung City, 833, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaoshiung, 807, Taiwan

Location

China Medical University Hospital

Taichung, 404328, Taiwan

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 407, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Chang Gung Memorial Hospital, Linkou

Taoyuan, 333, Taiwan

Location

Chang Gung Memorial Hospital Linkou

Taoyuan City, 333, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

cagrilintide; semaglutide; Tirzepatide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: November 5, 2024
• Primary Completion (Estimated): June 2, 2026
• Study Completion (Estimated): July 14, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (54); CA (13); IL (7); ES (6); PL (9); DE (8); AR (7); AU (7); BR (3); TW (10); GR (8); IN (13); RO (8); HU (10)