AzTrials
AzTrials

Type 2 DiabetesPhase 3NCT06221969

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

A Phase 3 study testing Cagrilintide, Semaglutide and Tirzepatide in people with Type 2 Diabetes, run by Novo Nordisk A/S at 197 sites in 8 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 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Cagrilintide, Semaglutide and Tirzepatide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,024 participants
Where
197 sitesin 8 countries
Study dates
16 Jan 2024to 6 Apr 2026
Phase
Phase 3
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 (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.

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.
  • 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.

Trial locations and contacts

197 sites in 8 countries.

197 sites in 8 countries

United States117 sites

  • AMC Community Endocrinology

    Albany, New York, 12203

  • Velocity Clin Res Albuquerque

    Albuquerque, New Mexico, 87107

  • Velocity Clinical Res-Anderson

    Anderson, South Carolina, 29621

  • Arlington Family Res. Ctr Inc

    Arlington, Texas, 76012-4637

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Velocity Clin Res

    Austin, Texas, 78759

  • AM Diabetes And Endocrinology Center

    Bartlett, Tennessee, 38133

  • UT Health University of Texas

    Bellaire, Texas, 77401

  • Belzoni Clinical Research

    Belzoni, Mississippi, 39038

  • Synexus Clin Res-Birmingham

    Birmingham, Alabama, 35211

  • Univ of Alabama_Birmingham

    Birmingham, Alabama, 35233

  • St. Luke's Health System

    Boise, Idaho, 83702

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

  • Holston Medical Group Pc

    Bristol, Tennessee, 37620

  • UNC Eastowne Clinical Research Unit

    Chapel Hill, North Carolina, 27514

  • Univ Diab & Endo Consultants

    Chattanooga, Tennessee, 37411

  • Diabetes & Endo Specialists Inc

    Chesterfield, Missouri, 63017

  • Cedar-Crosse Research Center

    Chicago, Illinois, 60607

  • Velocity Clin Res-Chula Vista

    Chula Vista, California, 91911

  • StudyMetrix Research LLC

    City of Saint Peters, Missouri, 63303

  • Optumcare Clinical Trials,LLC-Golden

    Colorado Springs, Colorado, 80906

  • Remington Davis Inc

    Columbus, Ohio, 43215

  • Hope Clin Res & Wellness

    Conyers, Georgia, 30094

  • Clinical Res Collaborative

    Cumberland, Rhode Island, 02864

  • Velocity Clin Res, Dallas

    Dallas, Texas, 75230

  • North Texas Endocrine Center

    Dallas, Texas, 75231

  • Synexus Clin Res Dallas

    Dallas, Texas, 75234

  • Cedar Health Research

    Dallas, Texas, 75251

  • Velocity Clin Res Providence

    East Greenwich, Rhode Island, 02818

  • Velocity Clin Res Syracuse

    East Syracuse, New York, 13057

  • Headlands Research California, LLC

    Escondido, California, 92025

  • Neighborhood Healthcare

    Escondido, California, 92025

  • Plains Clinical Research Center, LLC

    Fargo, North Dakota, 58104

  • St. Jude Heritage Yorba Linda - Pediatric Ste D

    Fullerton, California, 92835

  • Center for Adv Res & Education

    Gainesville, Georgia, 30501

  • Prime Medical Group, LLC

    Gilbert, Arizona, 85296

  • Prevea Health

    Green Bay, Wisconsin, 54303

  • American Health Network of Indiana, LLC_Greenfield

    Greenfield, Indiana, 46140

  • PharmQuest Life Sciences LLC

    Greensboro, North Carolina, 27408

  • Velocity Clin Res Gulfport

    Gulfport, Mississippi, 39503

  • Clinical Invest Special_Gurnee

    Gurnee, Illinois, 60031

  • Pacific Diabetes & Endo Ctr

    Honolulu, Hawaii, 96813

  • CCT Research

    Horsham, Pennsylvania, 19044

  • PrimeCare Medical Group

    Houston, Texas, 77024

  • JCCT- Juno NW Houston

    Houston, Texas, 77040

  • Discovery MM Services, Inc

    Houston, Texas, 77061

  • PlanIt Research, PLLC

    Houston, Texas, 77079

  • Amir Ali Hassan, MD, PA

    Houston, Texas, 77089

  • MedStar Hlth Res Institute

    Hyattsville, Maryland, 20782

  • Jackson Clinic

    Jackson, Tennessee, 38305

  • Northeast Res Inst. Inc.

    Jacksonville, Florida, 32204

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Diabetes & Endocrine Specialists - La Mesa

    La Mesa, California, 91942

  • Diabetes and Endocrine Specialists - La Mesa

    La Mesa, California, 91942

  • Velocity Clin Res San Diego

    La Mesa, California, 91942

  • Velocity Clin Res Lafayette

    Lafayette, Louisiana, 70508

  • Fmc Science, Llc

    Lampasas, Texas, 76550

  • Headlands Research CTR Lincoln

    Lincoln, California, 95648

  • Arkansas Clinical Research

    Little Rock, Arkansas, 72205

  • Loma Linda Univ Hlth Cr Endo

    Loma Linda, California, 92354

  • Urban Family Practice Assoc

    Marietta, Georgia, 30067

  • Advanced Medical Research

    Maumee, Ohio, 43537

  • Clinical Neuroscience Solutions

    Memphis, Tennessee, 38119

  • Solaris Clinical Research

    Meridian, Idaho, 83646

  • Bioclinical Research Alliance

    Miami, Florida, 33155

  • New Horizon Research Center

    Miami, Florida, 33165

  • International Diabetes Center

    Minneapolis, Minnesota, 55416

  • South Broward Research LLC

    Miramar, Florida, 33027

  • Carteret Medical Group

    Morehead City, North Carolina, 28557

  • Centricity Rsrch MHCity Multi

    Morehead City, North Carolina, 28557

  • HealthStar Physicians PC

    Morristown, Tennessee, 37813

  • Trial Management Associates

    Myrtle Beach, South Carolina, 29572

  • Clinical Research Associates

    Nashville, Tennessee, 37203

  • TPMG Clinical Research

    Newport News, Virginia, 23606

  • Lynn Institute of Norman

    Norman, Oklahoma, 73072

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

  • West Orange Endocrinology

    Ocoee, Florida, 34761

  • Optimal Research Sites

    Orange City, Florida, 32763

  • Trans Res Inst for Met & Diab

    Orlando, Florida, 32804

  • Oviedo Medical Research, LLC

    Oviedo, Florida, 32765

  • Desert Oasis Healthcare

    Palm Springs, California, 92262

  • Velocity Clin Res - Panorama

    Panorama City, California, 91402

  • Center for Diab,Obes & Metab

    Pembroke Pines, Florida, 33024

  • Thomas Jefferson University_Philadelphia

    Philadelphia, Pennsylvania, 19114

  • Velocity Clinical Research-Phoenix

    Phoenix, Arizona, 85006

  • Synexus Rsch /Cnt Phnx Med C

    Phoenix, Arizona, 85020

  • Western University of Health Sciences

    Pomona, California, 91766

  • Rainier Clin Res Ctr Inc

    Renton, Washington, 98057

  • Endocrine Research Solutions

    Roswell, Georgia, 30076

  • Foothill Family Clinic South

    Salt Lake City, Utah, 84121

  • Quality Clinical Research, Inc.

    San Antonio, Texas, 78209

  • University of Texas San Antonio

    San Antonio, Texas, 78229

  • NE Clin Res of San Antonio

    San Antonio, Texas, 78233

  • University of Texas San Antonio

    San Antonio, Texas, 78284

  • Endocrinology Josel Cabaccan

    San Jose, California, 95148

  • Mills-Peninsula Medical Center

    San Mateo, California, 94401

  • NorCal Endocrinology and Internal Medicine

    San Ramon, California, 94583

  • Unity Health-Searcy Medical Center

    Searcy, Arkansas, 72143

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

  • Hillcrest Clinical Research

    Simpsonville, South Carolina, 29681-1538

  • Endeavor Health

    Skokie, Illinois, 60077

  • Evanston Premier Hlthcr Res

    Skokie, Illinois, 60077

  • J.Lewis Research Inc

    South Jordan, Utah, 84095

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303

  • Amicis Centers of Clinical Research

    St Louis, Missouri, 63128

  • Piedmont Healthcare/Research

    Statesville, North Carolina, 28625

  • Mt Olympus Medical Research, LLC

    Sugar Land, Texas, 77478

  • Premier Medical Center, Inc.

    Toluca Lake, California, 91602

  • DM Clin Rsrch/Fam Diag Clinic

    Tomball, Texas, 77375

  • Cotton-O'Neil Diab & Endo Ctr

    Topeka, Kansas, 66606

  • Velocity Clin Res - Panorama

    Van Nuys, California, 91405

  • New Venture Medical Research

    Wadsworth, Ohio, 44281-9236

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • Iowa Diabetes & Endo Res Ctr

    West Des Moines, Iowa, 50266

  • Velocity Clin Res-Salt Lk City

    West Jordan, Utah, 84088

  • Southgate Medical Group, LLP

    West Seneca, New York, 14224

  • Accellacare

    Wilmington, North Carolina, 28401

Other trials in United States

Canada20 sites

  • Centricity Research Oshawa

    Barrie, West Oshawa, L4N 7L3

  • Centricity Research Brampton Endocrinology

    Brampton, Ontario, L6S 0C6

  • Centricity Research Calgary Endocrinology

    Calgary, Alberta, T2H 2G4

  • Milestone Research

    London, Ontario, N5W 6A2

  • Western Univ. Cnt for Studies in Fam Med

    London, Ontario, N6G 2M1

  • G.A. Research Associates Ltd.

    Moncton, New Brunswick, E1G 1A7

  • Centre Medical Acadie

    Montreal, Quebec, H4N 2W2

  • ALPHA Recherche Clinique

    Québec, Quebec, G3K 2P8

  • Clin des Mal Lipid de Quebec

    Québec, G1V 4W2

  • Clinique des Maladies Lipidiques de Quebec Inc.

    Québec, G1V 4W2

  • Centre de Recherche Saint-Louis

    Québec, G1W 4R4

  • London Road Diagnostic Clinic and Medical Centre

    Sarnia, Ontario, N7T 4X3

  • Guilford Med Clinic

    Surrey, British Columbia, V3R 4H6

  • TLC Diabetes and Endocrinology

    Surrey, British Columbia, V3T0X6

  • Ocean West Research Clinic

    Surrey, British Columbia, V3Z 2N6

  • Hilltop Medical Clinic

    Surrey, British Columbia, V4A 0C1

  • Ctr de Med Metab de Lanaudiere

    Terrebonne, Quebec, J6X 4P7

  • Centricity Research Toronto

    Toronto, Ontario, M4G 3E8

  • Diabetes Heart Research Centre

    Toronto, Ontario, M6G 1M2

  • Diex Recherche Victoriaville

    Victoriaville, Quebec, G6P 3Z8

Other trials in Canada

India20 sites

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

    Aligarh, 202002

  • Belgaum Diabetes Centre

    Belagavi, Karnataka, 590001

  • SRM Centre for Clinical Trials & Research

    Chennai, 603203

  • Maulana Azad Medical College

    Delhi, New Delhi, 110002

  • AIG Hospitals,Hyderabad

    Hyderabad, Telangana, 500032

  • SMS Medical College & Hospital

    Jaipur, Rajasthan, 302004

  • Diabetes, Thyroid and Endocrine Centre

    Jaipur, Rajasthan, 302006

  • BP Poddar Hospital

    Kolkata, West Bengal, 700053

  • Government Medical College, Kozhikode

    Kozhikode, Kerala, 673008

  • Seth GS Medical College & KEM Hospital

    Mumbai, Maharashtra, 400012

  • BSES MG hospital

    Mumbai, Maharashtra, 400058

  • Government Institute of Medical Sciences

    Noida, Uttar Pradesh, 201310

  • Grant Medical Foundation Ruby Hall Clinic

    Pune, Maharashtra, 411001

  • Chellaram Diabetes Institute

    Pune, Maharashtra, 411021

  • Nirmal Hospital Pvt. Ltd.

    Surat, Gujarat, 395002

  • Nirmal Hospital Pvt. Ltd.

    Surat, 395002

  • Indian Institute of Diabetes

    Thiruvnanthapuram, Kerala, 695033

  • Jothydev's Diabetes & Research Center

    Thriruvananthapuram, 695 032

  • SSG Hospital, Baroda

    Vadodara, Gujarat, 390001

  • Christian Medical College Hospital, Vellore

    Vellore, Tamil Nadu, 632004

Other trials in India

Australia12 sites

  • Paratus Clinical

    Blacktown, New South Wales, 2148

  • Townsville University Hospital

    Douglas, Queensland, 4814

  • Paratus Clinical

    Kanwal, New South Wales, 2259

  • Hunter Diabetes Centre

    Merewether, New South Wales, 2291

  • University of Sunshine Coast - Morayfield

    Morayfield, Queensland, 4506

  • Southern Adelaide Diabetes & Endocrine Services

    Oaklands Park, South Australia, 5046

  • The Royal Melbourne Hospital - Diabetes & Endocrinology Department

    Parkville, Victoria, 3050

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Austrials

    St Albans, Victoria, 3021

  • Momentum Clinical Research Sunshine

    St Albans, Victoria, 3021

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Momentum Clinical Research Taringa

    Taringa, Queensland, 4068

Other trials in Australia

Argentina10 sites

  • Instituto de Investigaciones Metabolicas (IDIM)

    Buenos Aires, C1012AAR

  • OMI- Organización Médica de Investigación

    Buenos Aires, C1015

  • CICEMO- Consultorio de Investigación Clínica EMO

    Buenos Aires, C1405BUB

  • CEDIC Centro de Investigación Clínica

    CABA, C1060ABA

  • Centro de Investigación Clínica

    CABA, C1060ABA

  • Buenos Aires Mácula

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1061AAE

  • CICEMO- Consultorio de Investigación Clínica EMO

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1405BUB

  • Instituto Medico Especializado_Capital Federal

    Ciudad de Buenos Aires, Buenos Aires, C1405CWB

  • Instituto de Investigaciones Clinicas Mar Del Plata

    Mar del Plata, Buenos Aires, B7600FZN

  • CEDIR - Centro de diagnóstico y rehabilitación Santa Fe

    Santa Fe, S3000FSO

Other trials in Argentina

Taiwan7 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Chung Shan Medical University Hospital

    Taichung, 402

  • Taichung Veterans General Hospital

    Taichung, 407

  • Kuang Tien General Hospital

    Taichung, 433

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital_main

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 112

Other trials in Taiwan

South Africa6 sites

  • Dr Wilhase's rooms

    Boksburg, Gauteng, 1466

  • Bella Vita Clinical Research

    Cape Town, Western Cape, 7560

  • Synapta Clinical Research Centre

    Durban, KwaZulu-Natal, 4001

  • Dr J Reddy

    Durban, KwaZulu-Natal, 4450

  • Ubuntu Clinical Research

    Johannesburg, Gauteng, 1827

  • Krugersdorp Medical Centre

    Krugersdorp, Gauteng, 1739

Other trials in South Africa

Colombia5 sites

  • Clinica de la Costa

    Barranquilla, Atlántico, 80020

  • Cimedical

    Barranquilla, 80001

  • UNIENDO

    Bogotá, 110111

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

    Bogotá, 110221

  • FOSCAL

    Floridablanca, Santander Department, 681004

Other trials in Colombia

About this study

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

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.

Conditions
Type 2 Diabetes
Being tested
Cagrilintide, Semaglutide, Tirzepatide
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • CagrilintideDrug

    Cagrilintide will be administered subcutaneously.

  • SemaglutideDrug

    Semaglutide will be administered subcutaneously.

  • TirzepatideDrug

    Tirzepatide will be administered subcutaneously.

Study groups in NCT06221969
Study groupRoleWhat they receive
CagriSemaExperimentalParticipants will receive cagrilintide dose 1 and semaglutide dose 2 subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 68 weeks.
Receives: Drug: Cagrilintide; Drug: Semaglutide
TirzepatideActive comparatorParticipants will receive tirzepatide dose 1 subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 68 weeks.
Receives: Drug: Tirzepatide

What is being measured

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

  1. Change in glycated haemoglobin (HbA1c)

    Measured in percentage (%)-points.

    Measured: From baseline (week 0) to end of treatment (week 68)

  2. Relative change in body weight

    Measured in percentage (%).

    Measured: From baseline (week 0) to end of treatment (week 68)

Secondary outcomes (22)

  1. Change in HbA1c

    Measured in %-points.

    Measured: From baseline (week 0) to end of treatment (week 68)

  2. Change in fasting plasma glucose (FPG)

    Measured in millimoles per liter (mmol/L).

    Measured: From baseline (week 0) to end of treatment (week 68)

  3. Achievement of HbA1c target values of less than (<) 7.0% (<53 millimole per mole [mmol/mol])

    Count of participant

    Measured: At end of treatment (week 68)

  4. Achievement of HbA1c target values of less than or equal to (≤) 6.5% (≤ 48 mmol/mol)

    Count of participant

    Measured: From baseline (week 0) to end of treatment (week 68)

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

    Count of participant

    Measured: From baseline (week 0) to end of treatment (week 68)

  6. Achievement of ≥ 10% weight reduction

    Count of participant

    Measured: From baseline (week 0) to end of treatment (week 68)

  7. Achievement of ≥ 15 % weight reduction

    Count of participant

    Measured: From baseline (week 0) to end of treatment (week 68)

  8. Achievement of ≥ 20 % weight reduction

    Count of participant

    Measured: From baseline (week 0) to end of treatment (week 68)

  9. Change in systolic blood pressure

    Measured in millimeters of mercury(mmHg).

    Measured: From baseline (week 0) to end of treatment (week 68)

  10. Change in diastolic blood pressure

    Measured in mmHg.

    Measured: From baseline (week 0) to end of treatment (week 68)

  11. Change in waist circumference

    Measured in centimeter (cm).

    Measured: From baseline (week 0) to end of treatment (week 68)

  12. Ratio to baseline in lipids: Total cholesterol

    Measured in ratio.

    Measured: From baseline (week 0) to end of treatment (week 68)

  13. Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol

    Measured in ratio.

    Measured: From baseline (week 0) to end of treatment (week 68)

  14. Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol

    Measured in ratio.

    Measured: From baseline (week 0) to end of treatment (week 68)

  15. Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol

    Measured in ratio.

    Measured: From baseline (week 0) to end of treatment (week 68)

  16. Ratio to baseline in lipids: Triglycerides

    Measured in ratio.

    Measured: From baseline (week 0) to end of treatment (week 68)

  17. Ratio to baseline in lipids: non-HDL cholesterol

    Measured in ratio.

    Measured: From baseline (week 0) to end of treatment (week 68)

  18. Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey

    The SF-36 v2 will be used to measure differences in quality of life and mental wellbeing. The scores 0-100 (where higher scores indicated a better quality of life and mental wellbeing) from the SF-36 will be converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 United States general population. Measured as score on a scale.

    Measured: From baseline (week 0) to end of treatment (week 68)

  19. Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) version 3

    IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Composite scores (score range): Physical composite (0-100), Psychosocial composite (0-100), Physical Function composite (0-100). Total score (0-100). Higher scores indicate better level of functioning.

    Measured: From baseline (week 0) to end of treatment (week 68)

  20. Number of Treatment-emergent Adverse Events (TEAEs)

    Count of events

    Measured: From baseline (week 0) to end of study (week 74)

  21. Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (<54 milligram per deciliter [mg/dL]), confirmed by blood glucose meter)

    Count of episodes

    Measured: From baseline (week 0) to end of study (week 74)

  22. 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 74)

Timeline

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

  1. First posted24 Jan 2024
  2. Study start16 Jan 2024
  3. Primary completion4 Mar 2026
  4. Study completion6 Apr 2026

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,024 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06221969
Sponsor's protocol ID
NN9388-4894
Other IDs
U1111-1282-5561, 2023-503789-21-00, 2023
Status last verified
Oct 2026
First submitted
15 Jan 2024
Last updated
19 Oct 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 3 study testing Cagrilintide, Semaglutide and Tirzepatide in people with Type 2 Diabetes, run by Novo Nordisk A/S at 197 sites in 8 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 6 inclusion and 4 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 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 197 sites in United States, Canada, India, Australia, Argentina and 3 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 glycated haemoglobin (HbA1c) (time frame: From baseline (week 0) to end of treatment (week 68)). The study lists 2 primary outcomes in all. 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 NCT06221969.

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 19 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in