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ACTIVE NOT RECRUITING
NCT06221969
PHASE3

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 With or Without an SGLT2 Inhibitor

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

This study will look at how well CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide that doctors may prescribe in some countries. Participants will get either CagriSema or tirzepatide. Which treatment participant get is decided by chance like flipping a coin. Participant will have an equal chance of receiving either drug. For each participant, the study will last for up to one and a half years.

Official title: Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 2.4 mg/2.4 mg s.c. Once Weekly Versus Tirzepatide 15 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin With or Without an SGLT2 Inhibitor

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2024-01-16

Completion Date

2026-04-03

Last Updated

2026-04-08

Healthy Volunteers

No

Conditions

Interventions

DRUG

Cagrilintide

Cagrilintide will be administered subcutaneously.

DRUG

Semaglutide

Semaglutide will be administered subcutaneously.

DRUG

Tirzepatide

Tirzepatide will be administered subcutaneously.

Locations (196)

Synexus Clin Res-Birmingham

Birmingham, Alabama, United States

Univ of Alabama_Birmingham

Birmingham, Alabama, United States

Prime Medical Group, LLC

Gilbert, Arizona, United States

Velocity Clinical Research-Phoenix

Phoenix, Arizona, United States

Synexus Rsch /Cnt Phnx Med C

Phoenix, Arizona, United States

Arkansas Clinical Research

Little Rock, Arkansas, United States

Unity Health-Searcy Medical Center

Searcy, Arkansas, United States

Velocity Clin Res-Chula Vista

Chula Vista, California, United States

Headlands Research California, LLC

Escondido, California, United States

Neighborhood Healthcare

Escondido, California, United States

St. Jude Heritage Yorba Linda - Pediatric Ste D

Fullerton, California, United States

Diabetes & Endocrine Specialists - La Mesa

La Mesa, California, United States

Diabetes and Endocrine Specialists - La Mesa

La Mesa, California, United States

Velocity Clin Res San Diego

La Mesa, California, United States

Clinical Trials Research

Lincoln, California, United States

Loma Linda Univ Hlth Cr Endo

Loma Linda, California, United States

Valley Clinical Trials, Inc.

Northridge, California, United States

Desert Oasis Healthcare

Palm Springs, California, United States

Velocity Clin Res - Panorama

Panorama City, California, United States

Western University of Health Sciences

Pomona, California, United States

Endocrinology Josel Cabaccan

San Jose, California, United States

Mills-Peninsula Medical Center

San Mateo, California, United States

NorCal Endocrinology and Internal Medicine

San Ramon, California, United States

Premier Medical Center, Inc.

Toluca Lake, California, United States

Velocity Clin Res - Panorama

Van Nuys, California, United States

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

University of Colorado Hospital

Aurora, Colorado, United States

Optumcare Clinical Trials,LLC-Golden

Colorado Springs, Colorado, United States

Northeast Res Inst. Inc.

Jacksonville, Florida, United States

Bioclinical Research Alliance

Miami, Florida, United States

New Horizon Research Center

Miami, Florida, United States

South Broward Research LLC

Miramar, Florida, United States

West Orange Endocrinology

Ocoee, Florida, United States

Optimal Research Sites

Orange City, Florida, United States

Trans Res Inst for Met & Diab

Orlando, Florida, United States

Oviedo Medical Research, LLC

Oviedo, Florida, United States

Center for Diab,Obes & Metab

Pembroke Pines, Florida, United States

Hope Clin Res & Wellness

Conyers, Georgia, United States

Center for Adv Res & Education

Gainesville, Georgia, United States

Urban Family Practice Assoc

Marietta, Georgia, United States

Endocrine Research Solutions

Roswell, Georgia, United States

Pacific Diabetes & Endo Ctr

Honolulu, Hawaii, United States

St. Luke's Health System

Boise, Idaho, United States

Solaris Clinical Research

Meridian, Idaho, United States

Cedar-Crosse Research Center

Chicago, Illinois, United States

Clinical Invest Special_Gurnee

Gurnee, Illinois, United States

Endeavor Health

Skokie, Illinois, United States

Evanston Premier Hlthcr Res

Skokie, Illinois, United States

American Health Network of Indiana, LLC_Greenfield

Greenfield, Indiana, United States

Iowa Diabetes & Endo Res Ctr

West Des Moines, Iowa, United States

Cotton-O'Neil Diab & Endo Ctr

Topeka, Kansas, United States

Velocity Clin Res Lafayette

Lafayette, Louisiana, United States

MedStar Hlth Res Institute

Hyattsville, Maryland, United States

Joslin Diabetes Center

Boston, Massachusetts, United States

International Diabetes Center

Minneapolis, Minnesota, United States

Belzoni Clinical Research

Belzoni, Mississippi, United States

Velocity Clin Res Gulfport

Gulfport, Mississippi, United States

Diabetes & Endo Specialists Inc

Chesterfield, Missouri, United States

StudyMetrix Research LLC

City of Saint Peters, Missouri, United States

Amicis Centers of Clinical Research

St Louis, Missouri, United States

Velocity Clin Res Albuquerque

Albuquerque, New Mexico, United States

AMC Community Endocrinology

Albany, New York, United States

Velocity Clin Res Syracuse

East Syracuse, New York, United States

Southgate Medical Group, LLP

West Seneca, New York, United States

UNC Eastowne Clinical Research Unit

Chapel Hill, North Carolina, United States

PharmQuest Life Sciences LLC

Greensboro, North Carolina, United States

Carteret Medical Group

Morehead City, North Carolina, United States

Centricity Rsrch MHCity Multi

Morehead City, North Carolina, United States

Piedmont Healthcare/Research

Statesville, North Carolina, United States

Accellacare

Wilmington, North Carolina, United States

Plains Clinical Research Center, LLC

Fargo, North Dakota, United States

Remington Davis Inc

Columbus, Ohio, United States

Advanced Medical Research

Maumee, Ohio, United States

New Venture Medical Research

Wadsworth, Ohio, United States

Lynn Institute of Norman

Norman, Oklahoma, United States

CCT Research

Horsham, Pennsylvania, United States

Thomas Jefferson University_Philadelphia

Philadelphia, Pennsylvania, United States

Clinical Res Collaborative

Cumberland, Rhode Island, United States

Velocity Clin Res Providence

East Greenwich, Rhode Island, United States

Velocity Clinical Res-Anderson

Anderson, South Carolina, United States

Trial Management Associates

Myrtle Beach, South Carolina, United States

Hillcrest Clinical Research

Simpsonville, South Carolina, United States

Spartanburg Medical Research

Spartanburg, South Carolina, United States

AM Diabetes And Endocrinology Center

Bartlett, Tennessee, United States

Holston Medical Group Pc

Bristol, Tennessee, United States

Univ Diab & Endo Consultants

Chattanooga, Tennessee, United States

Jackson Clinic

Jackson, Tennessee, United States

Holston Medical Group

Kingsport, Tennessee, United States

Clinical Neuroscience Solutions

Memphis, Tennessee, United States

HealthStar Physicians PC

Morristown, Tennessee, United States

Clinical Research Associates

Nashville, Tennessee, United States

Arlington Family Res. Ctr Inc

Arlington, Texas, United States

Velocity Clin Res

Austin, Texas, United States

UT Health University of Texas

Bellaire, Texas, United States

Velocity Clin Res, Dallas

Dallas, Texas, United States

North Texas Endocrine Center

Dallas, Texas, United States

Synexus Clin Res Dallas

Dallas, Texas, United States

Cedar Health Research

Dallas, Texas, United States

PrimeCare Medical Group

Houston, Texas, United States

JCCT- Juno NW Houston

Houston, Texas, United States

Discovery MM Services, Inc

Houston, Texas, United States

PlanIt Research, PLLC

Houston, Texas, United States

Amir Ali Hassan, MD, PA

Houston, Texas, United States

Fmc Science, Llc

Lampasas, Texas, United States

Quality Clinical Research, Inc.

San Antonio, Texas, United States

University of Texas San Antonio

San Antonio, Texas, United States

NE Clin Res of San Antonio

San Antonio, Texas, United States

University of Texas San Antonio

San Antonio, Texas, United States

Consano Clinical Research, LLC

Shavano Park, Texas, United States

Mt Olympus Medical Research, LLC

Sugar Land, Texas, United States

DM Clin Rsrch/Fam Diag Clinic

Tomball, Texas, United States

Foothill Family Clinic South

Salt Lake City, Utah, United States

J.Lewis Research Inc

South Jordan, Utah, United States

Velocity Clin Res-Salt Lk City

West Jordan, Utah, United States

TPMG Clinical Research

Newport News, Virginia, United States

Rainier Clin Res Ctr Inc

Renton, Washington, United States

Prevea Health

Green Bay, Wisconsin, United States

Buenos Aires Mácula

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

CICEMO- Consultorio de Investigación Clínica EMO

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Instituto Medico Especializado_Capital Federal

Ciudad de Buenos Aires, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Mar Del Plata

Mar del Plata, Buenos Aires, Argentina

Instituto de Investigaciones Metabolicas (IDIM)

Buenos Aires, Argentina

OMI- Organización Médica de Investigación

Buenos Aires, Argentina

CICEMO- Consultorio de Investigación Clínica EMO

Buenos Aires, Argentina

CEDIC Centro de Investigación Clínica

CABA, Argentina

Centro de Investigación Clínica

CABA, Argentina

CEDIR - Centro de diagnóstico y rehabilitación Santa Fe

Santa Fe, Argentina

Paratus Clinical

Blacktown, New South Wales, Australia

Paratus Clinical

Kanwal, New South Wales, Australia

Hunter Diabetes Centre

Merewether, New South Wales, Australia

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Townsville University Hospital

Douglas, Queensland, Australia

University of Sunshine Coast - Morayfield

Morayfield, Queensland, Australia

Momentum Clinical Research Taringa

Taringa, Queensland, Australia

Southern Adelaide Diabetes & Endocrine Services

Oaklands Park, South Australia, Australia

The Royal Melbourne Hospital - Diabetes & Endocrinology Department

Parkville, Victoria, Australia

The Royal Melbourne Hospital

Parkville, Victoria, Australia

Austrials

St Albans, Victoria, Australia

Momentum Clinical Research Sunshine

St Albans, Victoria, Australia

Centricity Research Calgary Endocrinology

Calgary, Alberta, Canada

Guilford Med Clinic

Surrey, British Columbia, Canada

TLC Diabetes and Endocrinology

Surrey, British Columbia, Canada

Ocean West Research Clinic

Surrey, British Columbia, Canada

Hilltop Medical Clinic

Surrey, British Columbia, Canada

G.A. Research Associates Ltd.

Moncton, New Brunswick, Canada

Centricity Research Brampton Endocrinology

Brampton, Ontario, Canada

Milestone Research

London, Ontario, Canada

Western Univ. Cnt for Studies in Fam Med

London, Ontario, Canada

London Road Diagnostic Clinic and Medical Centre

Sarnia, Ontario, Canada

Centricity Research Toronto

Toronto, Ontario, Canada

Diabetes Heart Research Centre

Toronto, Ontario, Canada

Centre Medical Acadie

Montreal, Quebec, Canada

ALPHA Recherche Clinique

Québec, Quebec, Canada

Ctr de Med Metab de Lanaudiere

Terrebonne, Quebec, Canada

Diex Recherche Victoriaville

Victoriaville, Quebec, Canada

Centricity Research Oshawa

Barrie, West Oshawa, Canada

Clin des Mal Lipid de Quebec

Québec, Canada

Centre de Recherche Saint-Louis

Québec, Canada

Clinica de la Costa

Barranquilla, Atlántico, Colombia

FOSCAL

Floridablanca, Santander Department, Colombia

Cimedical

Barranquilla, Colombia

UNIENDO

Bogotá, Colombia

Centro de Investigación en Reumatología y Especialidades Médicas S.A.S. CIREEM S.A.S.

Bogotá, Colombia

Nirmal Hospital Pvt. Ltd.

Surat, Gujarat, India

SSG Hospital, Baroda

Vadodara, Gujarat, India

Belgaum Diabetes Centre

Belagavi, Karnataka, India

Government Medical College, Kozhikode

Kozhikode, Kerala, India

Indian Institute of Diabetes

Thiruvnanthapuram, Kerala, India

Seth GS Medical College & KEM Hospital

Mumbai, Maharashtra, India

BSES MG hospital

Mumbai, Maharashtra, India

Grant Medical Foundation Ruby Hall Clinic

Pune, Maharashtra, India

Chellaram Diabetes Institute

Pune, Maharashtra, India

Maulana Azad Medical College

Delhi, New Delhi, India

SMS Medical College & Hospital

Jaipur, Rajasthan, India

Diabetes, Thyroid and Endocrine Centre

Jaipur, Rajasthan, India

Christian Medical College Hospital, Vellore

Vellore, Tamil Nadu, India

AIG Hospitals,Hyderabad

Hyderabad, Telangana, India

Government Institute of Medical Sciences

Noida, Uttar Pradesh, India

BP Poddar Hospital

Kolkata, West Bengal, India

Rajiv Gandhi Centre for Diabetes and Endocrinology, J.N Medical College, Aligarh Muslim University

Aligarh, India

SRM Centre for Clinical Trials & Research

Chennai, India

Nirmal Hospital Pvt. Ltd.

Surat, India

Jothydev's Diabetes & Research Center

Thriruvananthapuram, India

Dr Wilhase's rooms

Boksburg, Gauteng, South Africa

Ubuntu Clinical Research

Johannesburg, Gauteng, South Africa

Krugersdorp Medical Centre

Krugersdorp, Gauteng, South Africa

Synapta Clinical Research Centre

Durban, KwaZulu-Natal, South Africa

Dr J Reddy

Durban, KwaZulu-Natal, South Africa

Bella Vita Clinical Research

Cape Town, Western Cape, South Africa

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Chung Shan Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

Kuang Tien General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital_main

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan