New combo shot CagriSema takes on tirzepatide in diabetes showdown

NCT ID NCT06221969

Disease control Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This study tested a new investigational drug called CagriSema against a currently available medicine, tirzepatide, in over 1,000 adults with type 2 diabetes. The goal was to see which works better at lowering blood sugar and body weight. Participants received weekly injections of either CagriSema or tirzepatide for up to a year and a half.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,024 people

The number who actually took part.

Started

Jan 2024

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female (sex at birth). * Age 18 years or above at the time of signing the informed consent. * Diagnosed with type 2 diabetes ≥ 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 with or without an sodium-glucose co-transporter-2 (SGLT2) inhibitor. * HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at screening. * Body mass index (BMI) of ≥ 30.0 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. 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. * Renal impairment with estimated Glomerular Filtration Rate \< 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) as determined by central laboratory at screening. * Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed. * 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.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 2 diabetes

Contacts and locations

Locations

AIG Hospitals,Hyderabad

Hyderabad, Telangana, 500032, India
ALPHA Recherche Clinique

Québec, Quebec, G3K 2P8, Canada
AM Diabetes And Endocrinology Center

Bartlett, Tennessee, 38133, United States
AMC Community Endocrinology

Albany, New York, 12203, United States
Accellacare

Wilmington, North Carolina, 28401, United States
Advanced Medical Research

Maumee, Ohio, 43537, United States
American Health Network of Indiana, LLC_Greenfield

Greenfield, Indiana, 46140, United States
Amicis Centers of Clinical Research

St Louis, Missouri, 63128, United States
Amir Ali Hassan, MD, PA

Houston, Texas, 77089, United States
Arkansas Clinical Research

Little Rock, Arkansas, 72205, United States
Arlington Family Res. Ctr Inc

Arlington, Texas, 76012-4637, United States
Austrials

St Albans, Victoria, 3021, Australia
BP Poddar Hospital

Kolkata, West Bengal, 700053, India
BSES MG hospital

Mumbai, Maharashtra, 400058, India
Belgaum Diabetes Centre

Belagavi, Karnataka, 590001, India
Bella Vita Clinical Research

Cape Town, Western Cape, 7560, South Africa
Belzoni Clinical Research

Belzoni, Mississippi, 39038, United States
Bioclinical Research Alliance

Miami, Florida, 33155, United States
Buenos Aires Mácula

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1061AAE, Argentina
CCT Research

Horsham, Pennsylvania, 19044, United States
CEDIC Centro de Investigación Clínica

CABA, C1060ABA, Argentina
CEDIR - Centro de diagnóstico y rehabilitación Santa Fe

Santa Fe, S3000FSO, Argentina
CICEMO- Consultorio de Investigación Clínica EMO

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1405BUB, Argentina
CICEMO- Consultorio de Investigación Clínica EMO

Buenos Aires, C1405BUB, Argentina
Carteret Medical Group

Morehead City, North Carolina, 28557, United States
Cedar Health Research

Dallas, Texas, 75251, United States
Cedar-Crosse Research Center

Chicago, Illinois, 60607, United States
Center for Adv Res & Education

Gainesville, Georgia, 30501, United States
Center for Diab,Obes & Metab

Pembroke Pines, Florida, 33024, United States
Centre Medical Acadie

Montreal, Quebec, H4N 2W2, Canada
Centre de Recherche Saint-Louis

Québec, G1W 4R4, Canada
Centricity Research Brampton Endocrinology

Brampton, Ontario, L6S 0C6, Canada
Centricity Research Calgary Endocrinology

Calgary, Alberta, T2H 2G4, Canada
Centricity Research Oshawa

Barrie, West Oshawa, L4N 7L3, Canada
Centricity Research Toronto

Toronto, Ontario, M4G 3E8, Canada
Centricity Rsrch MHCity Multi

Morehead City, North Carolina, 28557, United States
Centro de Investigación Clínica

CABA, C1060ABA, Argentina
Centro de Investigación en Reumatología y Especialidades Médicas S.A.S. CIREEM S.A.S.

Bogotá, 110221, Colombia
Chellaram Diabetes Institute

Pune, Maharashtra, 411021, India
Christian Medical College Hospital, Vellore

Vellore, Tamil Nadu, 632004, India
Chung Shan Medical University Hospital

Taichung, 402, Taiwan
Cimedical

Barranquilla, 80001, Colombia
Clin des Mal Lipid de Quebec

Québec, G1V 4W2, Canada
Clinica de la Costa

Barranquilla, Atlántico, 80020, Colombia
Clinical Invest Special_Gurnee

Gurnee, Illinois, 60031, United States
Clinical Neuroscience Solutions

Memphis, Tennessee, 38119, United States
Clinical Res Collaborative

Cumberland, Rhode Island, 02864, United States
Clinical Research Associates

Nashville, Tennessee, 37203, United States
Clinique des Maladies Lipidiques de Quebec Inc.

Québec, G1V 4W2, Canada
Consano Clinical Research, LLC

Shavano Park, Texas, 78231, United States
Cotton-O'Neil Diab & Endo Ctr

Topeka, Kansas, 66606, United States
Ctr de Med Metab de Lanaudiere

Terrebonne, Quebec, J6X 4P7, Canada
DM Clin Rsrch/Fam Diag Clinic

Tomball, Texas, 77375, United States
Desert Oasis Healthcare

Palm Springs, California, 92262, United States
Diabetes & Endo Specialists Inc

Chesterfield, Missouri, 63017, United States
Diabetes & Endocrine Specialists - La Mesa

La Mesa, California, 91942, United States
Diabetes Heart Research Centre

Toronto, Ontario, M6G 1M2, Canada
Diabetes and Endocrine Specialists - La Mesa

La Mesa, California, 91942, United States
Diabetes, Thyroid and Endocrine Centre

Jaipur, Rajasthan, 302006, India
Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States
Diex Recherche Victoriaville

Victoriaville, Quebec, G6P 3Z8, Canada
Discovery MM Services, Inc

Houston, Texas, 77061, United States
Dr J Reddy

Durban, KwaZulu-Natal, 4450, South Africa
Dr Wilhase's rooms

Boksburg, Gauteng, 1466, South Africa
Endeavor Health

Skokie, Illinois, 60077, United States
Endocrine Research Solutions

Roswell, Georgia, 30076, United States
Endocrinology Josel Cabaccan

San Jose, California, 95148, United States
Evanston Premier Hlthcr Res

Skokie, Illinois, 60077, United States
FOSCAL

Floridablanca, Santander Department, 681004, Colombia
Fmc Science, Llc

Lampasas, Texas, 76550, United States
Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States
G.A. Research Associates Ltd.

Moncton, New Brunswick, E1G 1A7, Canada
Government Institute of Medical Sciences

Noida, Uttar Pradesh, 201310, India
Government Medical College, Kozhikode

Kozhikode, Kerala, 673008, India
Grant Medical Foundation Ruby Hall Clinic

Pune, Maharashtra, 411001, India
Guilford Med Clinic

Surrey, British Columbia, V3R 4H6, Canada
Headlands Research CTR Lincoln

Lincoln, California, 95648, United States
Headlands Research California, LLC

Escondido, California, 92025, United States
HealthStar Physicians PC

Morristown, Tennessee, 37813, United States
Hillcrest Clinical Research

Simpsonville, South Carolina, 29681-1538, United States
Hilltop Medical Clinic

Surrey, British Columbia, V4A 0C1, Canada
Holston Medical Group

Kingsport, Tennessee, 37660, United States
Holston Medical Group Pc

Bristol, Tennessee, 37620, United States
Hope Clin Res & Wellness

Conyers, Georgia, 30094, United States
Hunter Diabetes Centre

Merewether, New South Wales, 2291, Australia
Indian Institute of Diabetes

Thiruvnanthapuram, Kerala, 695033, India
Instituto Medico Especializado_Capital Federal

Ciudad de Buenos Aires, Buenos Aires, C1405CWB, Argentina
Instituto de Investigaciones Clinicas Mar Del Plata

Mar del Plata, Buenos Aires, B7600FZN, Argentina
Instituto de Investigaciones Metabolicas (IDIM)

Buenos Aires, C1012AAR, Argentina
International Diabetes Center

Minneapolis, Minnesota, 55416, United States
Iowa Diabetes & Endo Res Ctr

West Des Moines, Iowa, 50266, United States
J.Lewis Research Inc

South Jordan, Utah, 84095, United States
JCCT- Juno NW Houston

Houston, Texas, 77040, United States
Jackson Clinic

Jackson, Tennessee, 38305, United States
Joslin Diabetes Center

Boston, Massachusetts, 02215, United States
Jothydev's Diabetes & Research Center

Thriruvananthapuram, 695 032, India
Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan
Krugersdorp Medical Centre

Krugersdorp, Gauteng, 1739, South Africa
Kuang Tien General Hospital

Taichung, 433, Taiwan
Loma Linda Univ Hlth Cr Endo

Loma Linda, California, 92354, United States
London Road Diagnostic Clinic and Medical Centre

Sarnia, Ontario, N7T 4X3, Canada
Lynn Institute of Norman

Norman, Oklahoma, 73072, United States
Maulana Azad Medical College

Delhi, New Delhi, 110002, India
MedStar Hlth Res Institute

Hyattsville, Maryland, 20782, United States
Milestone Research

London, Ontario, N5W 6A2, Canada
Mills-Peninsula Medical Center

San Mateo, California, 94401, United States
Momentum Clinical Research Sunshine

St Albans, Victoria, 3021, Australia
Momentum Clinical Research Taringa

Taringa, Queensland, 4068, Australia
Mt Olympus Medical Research, LLC

Sugar Land, Texas, 77478, United States
NE Clin Res of San Antonio

San Antonio, Texas, 78233, United States
National Cheng Kung University Hospital

Tainan, 704, Taiwan
National Taiwan University Hospital_main

Taipei, 100, Taiwan
Neighborhood Healthcare

Escondido, California, 92025, United States
New Horizon Research Center

Miami, Florida, 33165, United States
New Venture Medical Research

Wadsworth, Ohio, 44281-9236, United States
Nirmal Hospital Pvt. Ltd.

Surat, Gujarat, 395002, India
Nirmal Hospital Pvt. Ltd.

Surat, 395002, India
NorCal Endocrinology and Internal Medicine

San Ramon, California, 94583, United States
North Texas Endocrine Center

Dallas, Texas, 75231, United States
Northeast Res Inst. Inc.

Jacksonville, Florida, 32204, United States
OMI- Organización Médica de Investigación

Buenos Aires, C1015, Argentina
Ocean West Research Clinic

Surrey, British Columbia, V3Z 2N6, Canada
Optimal Research Sites

Orange City, Florida, 32763, United States
Optumcare Clinical Trials,LLC-Golden

Colorado Springs, Colorado, 80906, United States
Oviedo Medical Research, LLC

Oviedo, Florida, 32765, United States
Pacific Diabetes & Endo Ctr

Honolulu, Hawaii, 96813, United States
Paratus Clinical

Blacktown, New South Wales, 2148, Australia
Paratus Clinical

Kanwal, New South Wales, 2259, Australia
PharmQuest Life Sciences LLC

Greensboro, North Carolina, 27408, United States
Piedmont Healthcare/Research

Statesville, North Carolina, 28625, United States
Plains Clinical Research Center, LLC

Fargo, North Dakota, 58104, United States
PlanIt Research, PLLC

Houston, Texas, 77079, United States
Premier Medical Center, Inc.

Toluca Lake, California, 91602, United States
Prevea Health

Green Bay, Wisconsin, 54303, United States
Prime Medical Group, LLC

Gilbert, Arizona, 85296, United States
PrimeCare Medical Group

Houston, Texas, 77024, United States
Quality Clinical Research, Inc.

San Antonio, Texas, 78209, United States
Rainier Clin Res Ctr Inc

Renton, Washington, 98057, United States
Rajiv Gandhi Centre for Diabetes and Endocrinology, J.N Medical College, Aligarh Muslim University

Aligarh, 202002, India
Remington Davis Inc

Columbus, Ohio, 43215, United States
Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia
SMS Medical College & Hospital

Jaipur, Rajasthan, 302004, India
SRM Centre for Clinical Trials & Research

Chennai, 603203, India
SSG Hospital, Baroda

Vadodara, Gujarat, 390001, India
Seth GS Medical College & KEM Hospital

Mumbai, Maharashtra, 400012, India
Solaris Clinical Research

Meridian, Idaho, 83646, United States
South Broward Research LLC

Miramar, Florida, 33027, United States
Southern Adelaide Diabetes & Endocrine Services

Oaklands Park, South Australia, 5046, Australia
Southgate Medical Group, LLP

West Seneca, New York, 14224, United States
Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States
St. Jude Heritage Yorba Linda - Pediatric Ste D

Fullerton, California, 92835, United States
St. Luke's Health System

Boise, Idaho, 83702, United States
StudyMetrix Research LLC

City of Saint Peters, Missouri, 63303, United States
Synapta Clinical Research Centre

Durban, KwaZulu-Natal, 4001, South Africa
Synexus Clin Res Dallas

Dallas, Texas, 75234, United States
Synexus Clin Res-Birmingham

Birmingham, Alabama, 35211, United States
Synexus Rsch /Cnt Phnx Med C

Phoenix, Arizona, 85020, United States
TLC Diabetes and Endocrinology

Surrey, British Columbia, V3T0X6, Canada
TPMG Clinical Research

Newport News, Virginia, 23606, United States
Taichung Veterans General Hospital

Taichung, 407, Taiwan
Taipei Veterans General Hospital

Taipei, 112, Taiwan
The Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia
The Royal Melbourne Hospital - Diabetes & Endocrinology Department

Parkville, Victoria, 3050, Australia
Thomas Jefferson University_Philadelphia

Philadelphia, Pennsylvania, 19114, United States
Townsville University Hospital

Douglas, Queensland, 4814, Australia
Trans Res Inst for Met & Diab

Orlando, Florida, 32804, United States
Trial Management Associates

Myrtle Beach, South Carolina, 29572, United States
UNC Eastowne Clinical Research Unit

Chapel Hill, North Carolina, 27514, United States
UNIENDO

Bogotá, 110111, Colombia
UT Health University of Texas

Bellaire, Texas, 77401, United States
Ubuntu Clinical Research

Johannesburg, Gauteng, 1827, South Africa
Unity Health-Searcy Medical Center

Searcy, Arkansas, 72143, United States
Univ Diab & Endo Consultants

Chattanooga, Tennessee, 37411, United States
Univ of Alabama_Birmingham

Birmingham, Alabama, 35233, United States
University of Colorado Hospital

Aurora, Colorado, 80045, United States
University of Sunshine Coast - Morayfield

Morayfield, Queensland, 4506, Australia
University of Texas San Antonio

San Antonio, Texas, 78229, United States
University of Texas San Antonio

San Antonio, Texas, 78284, United States
Urban Family Practice Assoc

Marietta, Georgia, 30067, United States
Valley Clinical Trials, Inc.

Northridge, California, 91325, United States
Velocity Clin Res

Austin, Texas, 78759, United States
Velocity Clin Res - Panorama

Panorama City, California, 91402, United States
Velocity Clin Res - Panorama

Van Nuys, California, 91405, United States
Velocity Clin Res Albuquerque

Albuquerque, New Mexico, 87107, United States
Velocity Clin Res Gulfport

Gulfport, Mississippi, 39503, United States
Velocity Clin Res Lafayette

Lafayette, Louisiana, 70508, United States
Velocity Clin Res Providence

East Greenwich, Rhode Island, 02818, United States
Velocity Clin Res San Diego

La Mesa, California, 91942, United States
Velocity Clin Res Syracuse

East Syracuse, New York, 13057, United States
Velocity Clin Res, Dallas

Dallas, Texas, 75230, United States
Velocity Clin Res-Chula Vista

Chula Vista, California, 91911, United States
Velocity Clin Res-Salt Lk City

West Jordan, Utah, 84088, United States
Velocity Clinical Res-Anderson

Anderson, South Carolina, 29621, United States
Velocity Clinical Research-Phoenix

Phoenix, Arizona, 85006, United States
West Orange Endocrinology

Ocoee, Florida, 34761, United States
Western Univ. Cnt for Studies in Fam Med

London, Ontario, N6G 2M1, Canada
Western University of Health Sciences

Pomona, California, 91766, United States

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