AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3REIMAGINE 5NCT06534411

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

A Phase 3 study testing Cagrilintide, Semaglutide and Tirzepatide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 163 sites in 14 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 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
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
1,023 participants
Where
163 sitesin 14 countries
Study dates
5 Nov 2024to 9 Jul 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 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.

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 less than < 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 anti-diabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days is 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

163 sites in 14 countries.

163 sites in 14 countries

United States54 sites

  • Albany Medical College

    Albany, New York, 12203

  • Velocity Clin Res Albuquerque

    Albuquerque, New Mexico, 87107

  • Velocity Clin Res Austin

    Austin, Texas, 78759

  • Velocity Clin Res-Chula Vista

    Chula Vista, California, 91911

  • Tampa Bay Medical Research

    Clearwater, Florida, 33761

  • Optumcare Clinical Trials,LLC-Golden

    Colorado Springs, Colorado, 80906

  • John Muir Physicians Network

    Concord, California, 94520

  • Clinical Res Collaborative

    Cumberland, Rhode Island, 02864

  • Synexus Clin Res Dallas

    Dallas, Texas, 75234

  • UT Southwestern Med Center

    Dallas, Texas, 75390

  • Velocity Clin Res Providence

    East Greenwich, Rhode Island, 02818

  • Lillestol Research LLC

    Fargo, North Dakota, 58104

  • Javara Inc. / Privia Medical Group Georgia LLC

    Fayetteville, Georgia, 30214

  • Velocity Clin Res Gaffney

    Gaffney, South Carolina, 29340

  • Velocity Clin Res Gulfport

    Gulfport, Mississippi, 39503

  • Clinical Invest Special_Gurnee

    Gurnee, Illinois, 60031

  • AGA Clinical Trial

    Hialeah, Florida, 33012

  • JCCT- Juno NW Houston

    Houston, Texas, 77040

  • Synergy Groups Medical

    Houston, Texas, 77061

  • PlanIt Research, PLLC

    Houston, Texas, 77079

  • Sante Clinical Research

    Kerrville, Texas, 78028

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Diabetes & Endocrine Specialists - La Mesa

    La Mesa, California, 91942

  • Aeres Clinical Research

    Laredo, Texas, 78041

  • Woodland Int. Research Group

    Little Rock, Arkansas, 72211

  • Velocity Clin Research LA

    Los Angeles, California, 90017

  • Biopharma Informatic, LLC

    McAllen, Texas, 78503

  • Bioclinical Research Alliance

    Miami, Florida, 33155

  • New Horizon Research Center

    Miami, Florida, 33165

  • South Broward Research LLC

    Miramar, Florida, 33027

  • Carteret Medical Group

    Morehead City, North Carolina, 28557

  • Clinical Research Associates

    Nashville, Tennessee, 37203

  • TPMG Clinical Research

    Newport News, Virginia, 23606

  • Triad Research Institute

    Norman, Oklahoma, 73072

  • West Orange Endocrinology

    Ocoee, Florida, 34761

  • Univ of Nebraska Medical CTR

    Omaha, Nebraska, 68198-3020

  • Optimal Research Sites

    Orange City, Florida, 32763

  • Desert Oasis Healthcare

    Palm Springs, California, 92262

  • Cahaba Research

    Pelham, Alabama, 35124

  • Center for Diab,Obes & Metab

    Pembroke Pines, Florida, 33024

  • Velocity Clinical Research-Phoenix

    Phoenix, Arizona, 85006

  • Circuit Clinical - PMSI

    Pottstown, Pennsylvania, 19464

  • AES Minneapolis DRS

    Richfield, Minnesota, 55423

  • J.Lewis Research Inc

    Salt Lake City, Utah, 84109

  • Velocity Clin Res Santa Ana

    Santa Ana, California, 92704

  • AES St. Louis DRS

    St Louis, Missouri, 63141

  • Chrysalis Clinical Research

    St. George, Utah, 84790

  • Piedmont Healthcare/Research

    Statesville, North Carolina, 28625

  • Privia Health Javara Clin Res.

    Stephenville, Texas, 76401

  • Cotton-Oneill Diabetes and End

    Topeka, Kansas, 66606-2806

  • AES Tucson DRS

    Tucson, Arizona, 85712

  • Velocity Clin Res - Panorama

    Van Nuys, California, 91405

  • FEME Medical LLC

    Washington D.C., District of Columbia, 20010

  • Iowa Diabetes & Endo Res Ctr

    West Des Moines, Iowa, 50266

Other trials in United States

Canada13 sites

  • Centricity Research Brampton Endocrinology

    Brampton, Ontario, L6S 0C6

  • Centricity Research Etobicoke Endocrinology

    Etobicoke, Ontario, M9R 4E1

  • Wharton Medical Clinic Clinical Trials (Hamilton)

    Hamilton, Ontario, L8L 5G8

  • Ctr de recherche Clinique de Laval

    Laval, Quebec, H7T 2P5

  • Alpha Recherche Clinique - Clinique de Levis

    Lévis, Quebec, G6V 0C9

  • G.A. Research Associates Ltd.

    Moncton, New Brunswick, E1G 1A7

  • Centre Medical Acadie

    Montreal, Quebec, H4N 2W2

  • Centre de Recherche Saint-Louis

    Québec, G1W 4R4

  • London Road Diagnostic Clinic and Medical Centre

    Sarnia, Ontario, N7T 4X3

  • Hilltop Medical Clinic

    Surrey, British Columbia, V4A 0C1

  • Ctr de Med Metab de Lanaudiere

    Terrebonne, Quebec, J6X 4P7

  • Diabetes Heart Research Centre

    Toronto, Ontario, M6G 1M2

  • Diex Recherche Victoriaville

    Victoriaville, Quebec, G6P 3Z8

Other trials in Canada

India13 sites

  • Jawahar Lal Nehru Govt. Medical College

    Ajmer, Rajasthan, 305001

  • Ramaiah Memorial Hospital

    Bengaluru, Karnataka, 560054

  • Endolife Specialty Hospitals

    Guntur, Andhra Pradesh, 522001

  • AIG Hospitals,Hyderabad

    Hyderabad, Telangana, 500032

  • SMS Hospital

    Jaipur, Rajasthan, 302004

  • Diabetes, Thyroid and Endocrine Centre

    Jaipur, Rajasthan, 302006

  • Excel Endocrine Centre

    Kolhāpur, Maharashtra, 416008

  • IPGME&R and SSKM Hospital

    Kolkata, West Bengal, 700020

  • Udyaan Health Care

    Lucknow, Uttar Pradesh, 226002

  • Arthur Asirvatham hospital,

    Madurai, Tamil Nadu, 625 020

  • All India Institute of Medical Sciences (AIIMS)

    New Delhi, National Capital Territory of Delhi, 110029

  • Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)

    Puducherry, Tamil Nadu, 605006

  • Acharya Vinoba Bhave Rural Hospital, Sawangi Meghe, Wardha

    Wardha, Maharashtra, 442001

Other trials in India

Hungary10 sites

  • Óbudai Egészségügyi Centrum

    Budapest, Pest County, 1036

  • QUALICLINIC Egészségügyi Szolgáltató és Kutatásszervező Kft

    Budapest, Pest County, 1134

  • Szőcs Depot Egészségügyi Szolgáltató Kft.

    Budapest, 1042

  • Semmelweis Egyetem

    Budapest, 1083

  • ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.

    Budapest, 1089

  • PVN Kutató Kft.

    Budapest, 1102

  • MED-TIMA Kft.

    Budapest, 1132

  • Észak-Pesti Centrumkórház Honvédkórház - Diabetológia Szakrendelés

    Budapest, 1134

  • Komáromi Selye János Kórház

    Komárom, Komárom-Esztergom, 2900

  • Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ

    Szeged, Csongrád-Csanád, 6725

Other trials in Hungary

Taiwan10 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Chang Gung Memorial Hospital - Kaohsiung Branch

    Kaohsiung City, 833

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaoshiung, 807

  • China Medical University Hospital

    Taichung, 404328

  • China Medical University Hospital

    Taichung, 404

  • Taichung Veterans General Hospital

    Taichung, 407

  • National Cheng Kung University Hospital

    Tainan, 704

  • Taipei Veterans General Hospital

    Taipei, 112

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, 333

  • Chang Gung Memorial Hospital Linkou

    Taoyuan City, 333

Other trials in Taiwan

Poland9 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, Podlaskie Voivodeship, 15-276

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-269

  • Diab Serwis Popenda Spółka Jawna

    Chorzów, 41-516

  • Specjalistyczny Gabinet Diabetologiczny Rumianowski Radosław

    Gorzów Wielkopolski, 66-400

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

    Lodz, Łódź Voivodeship, 90-338

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

    Olsztyn, 10-117

  • Kiepury Clinic MALGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POLOZNICZA

    Sosnowiec, 41-209

  • Centrum Medyczne Oporow

    Wroclaw, 52-416

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

    Zabrze, 41-800

Other trials in Poland

Germany8 sites

  • Herz- und Diabeteszentrum NRW - Bad Oeynhausen

    Bad Oeynhausen, 32545

  • Universitätsklinikum Essen - Klinik für Endokrinologie, Diabetologie und Stoffwechsel

    Essen, 45147

  • Praxis am Markt Dr. Becker

    Essen, 45355

  • Universitätsklinikum Freiburg - Innere Medizin II

    Freiburg im Breisgau, 79106

  • Wendisch - Dahl Hamburg - DZHW

    Hamburg, 22607

  • Medicover Neuroendokrinologie MVZ München

    München, 81667

  • MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin

    Münster, 48153

  • Zentrum für klinische Studien Allgäu Oberschwaben

    Wangen, 88239

Other trials in Germany

Greece8 sites

  • Alexandra General Hospital, Therapeutic Clinic

    Athens, Attica, 11528

  • Evangelismos Hospital

    Athens, 10676

  • Iatriko Athinon 'Palaiou Falirou'

    Athens, 17562

  • "Laiko" General Hospital of Athens

    Goudi/Athens, 11527

  • General Hospital Venizeleio-Pananeio - Diabetic Clinic

    Heraklion, Crete, 71409

  • University General Hospital of Ioannina,Internal Medicine

    Ioannina, 45500

  • General Hospital of Thessaloniki 'G. Gennimatas

    Thessaloniki, 54635

  • 'Ippokrateio' General Hospital of Thessaloniki

    Thessaloniki, 54642

Other trials in Greece

Romania8 sites

  • CMI Dr Pop Lavinia

    Baia Mare, Maramureş, 430222

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

    Bucharest, Bucharest, 020475

  • SC Nutrilife SRL

    Bucharest, 013764

  • Diabet Med SRL

    Bucharest, 050913

  • Sanamed Hospital SRL

    Bucharest, 060013

  • Diabdana S.R.L.

    Oradea, Bihor County, 410147

  • Clinica Korall S.R.L. Satu Mare

    Satu Mare, 440055

  • Sc Mediab Srl

    Târgu Mureş, Mureș County, 540142

Other trials in Romania

Argentina7 sites

  • IMOBA

    City of Buenos Aires, C1056ABH

  • Centro de Investigaciones Metabólicas

    City of Buenos Aires, C1056ABI

  • Centro Médico CIMEL

    Lanús Este, Buenos Aires, B1824KAJ

  • Centro de Investigaciones Médicas Mar del Plata

    Mar del Plata, Buenos Aires, B7600GNY

  • Centro de Investigaciones Médicas Tucumán

    San Miguel de Tucuimán, Tucumán Province, 4000

  • Instituto de Investigaciones Clinicas San Nicolás

    San Nicolás, B2900

  • Fundación CESIM

    Santa Rosa, La Pampa Province, 6300

Other trials in Argentina

Australia7 sites

  • Paratus Clinical

    Bruce, Australian Capital Territory, 2617

  • Townsville University Hospital

    Douglas, Queensland, 4814

  • Paratus Clinical

    Herston, Queensland, 4006

  • Hunter Diabetes Centre

    Merewether, New South Wales, 2291

  • Austrials

    St Leonards, New South Wales, 2065

  • Momentum Clinical Research St Leonards

    St Leonards, New South Wales, 2065

  • Roger Chih Yu Chen

    Sydney, New South Wales, 2148

Other trials in Australia

Israel7 sites

  • Rambam MC - Diabetes and obesity center of excellence

    Haifa, 31096

  • Clalit sick fund Herzeliya

    Herzeliya, Israel, 4630945

  • Wolfson MC - Diabetes Clinic

    Holon, 58100

  • Hadassah Ein Karam MC - Diabetes Unit

    Jerusalem, 91120

  • Rabin MC Beilinson - Endo unit

    Petah Tikva, 49100

  • Sourasky MC - Institute of Endocrinology, metabolism and hypertension

    Tel Aviv, 6423906

  • Sheba MC - Endocrinology Clinic

    Tel HaShomer, 52621

Other trials in Israel

Spain6 sites

  • Centro Periferico De Especialidades Bola Azul

    Almería, 04009

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario San Cecilio

    Granada, 18016

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008

  • Clínica Nuevas Tecnologías en Diabetes y Endocrinología

    Seville, 41003

  • Hospital Clínico de Valladolid

    Valladolid, 47003

Other trials in Spain

Brazil3 sites

  • Centro de Diabetes Curitiba

    Curitiba, Paraná, 80810-040

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

    Porto Alegre, Rio Grande do Sul, 90430-001

  • CPQuali Pesquisa Clínica Ltda

    São Paulo, São Paulo, 01228-000

Other trials in Brazil

About this study

Official title: Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 1.0 mg/1.0 mg s.c. Once Weekly Versus Tirzepatide 5 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin, SGLT2 Inhibitor or Both

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.

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

    Participants will receive once-weekly cagrilintide subcutaneously.

  • SemaglutideDrug

    Participants will receive once-weekly semaglutide subcutaneously.

  • TirzepatideDrug

    Participants will receive once-weekly tirzepatide subcutaneously.

Study groups in NCT06534411
Study groupRoleWhat they receive
CagriSemaExperimentalParticipants 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.
Receives: Drug: Cagrilintide; Drug: Semaglutide
TirzepatideExperimentalParticipants 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.
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 60)

  2. Relative Change in Body Weight

    Measured in percentage (%).

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

Secondary outcomes (25)

  1. Change in HbA1c

    Measured in percentage points.

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

  2. Change in Fasting Plasma Glucose (FPG)

    Measured as millimole per liter (mmol/L).

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

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

    Measured as count of participants.

    Measured: At end of treatment (week 60)

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

    Measured as count of participants.

    Measured: At end of treatment (week 60)

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

    Measured as count of participants.

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

  6. Number of Participants Who Achieve >= 10% Weight Reduction

    Measured as count of participants.

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

  7. Number of Participants Who Achieve >= 15% Weight Reduction

    Measured as count of participants.

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

  8. Number of Participants Who Achieve >= 20% Weight Reduction

    Measured as count of participants.

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

  9. Change in Systolic Blood Pressure (SBP)

    Measured in millimeter of mercury (mmHg).

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

  10. Change in Diastolic Blood Pressure (DBP)

    Measured in mmHg.

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

  11. Change in Waist Circumference

    Measured in centimeter (cm).

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

  12. Ratio to Baseline in Lipids: Total Cholesterol

    Measured as ratio.

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

  13. Ratio to Baseline in Lipids: High Density Lipoprotein (HDL) Cholesterol

    Measured as ratio.

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

  14. Ratio to Baseline in Lipids: Low Density Lipoprotein (LDL) Cholesterol

    Measured as ratio.

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

  15. Ratio to Baseline in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol

    Measured as ratio.

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

  16. Ratio to Baseline in Lipids: Triglycerides

    Measured as ratio.

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

  17. Ratio to Baseline in Lipids: Non-HDL cholesterol

    Measured as ratio.

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

  18. Change in Short Form (SF) -36v2 Score: Physical Component Summary Score

    Measured as score points. SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2. Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Physical component summary scores ranges from 6.1 to 79.7 with higher scores indicating better functional health and well-being.

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

  19. Change in SF-36v2 Score: Mental Component Summary Score

    Measured as score points. SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2. Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Mental component summary scores ranges from -3.8 to 78.7 with higher scores indicating better functional health and well-being.

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

  20. Change in SF-36v2 Score: Vitality Subscale

    Measured as score points. SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2. Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Vitality score ranges from 25.6 to 69.1 with higher scores indicating better functional health and well-being.

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

  21. Change in Impact of Weight on Quality of Life Lite for Clinical Trials Version (IWQOL-Lite-CT) : Physical Function score

    Measured as score points. 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. Physical functioning score ranges from 0 to 100, with higher scores reflecting better levels of functioning.

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

  22. Change in IWQOL-Lite-CT: Total score

    Measured as score points. 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. Total score ranges from 0 to 100, with higher scores reflecting better levels of functioning.

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

  23. Number of Treatment Emergent Adverse Events (TEAEs)

    Measured as count of events.

    Measured: From baseline (week 0) to end of study (week 66)

  24. Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (<54 Milligram per Deciliter [mg/dL]), Confirmed by Blood Glucose (BG) Meter

    Measured as count of episodes.

    Measured: From baseline (week 0) to end of study (week 66)

  25. Number of Severe Hypoglycaemic Episodes (Level 3): Hypoglycaemia Associated With Severe Cognitive Impairment Requiring External Assistance for Recovery, With no Specific Glucose Threshold

    Measured as count of episodes.

    Measured: From baseline (week 0) to end of study (week 66)

Timeline

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

  1. First posted2 Aug 2024
  2. Study start5 Nov 2024
  3. Primary completion2 Jun 2026
  4. Study completion9 Jul 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
1,023 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06534411
Sponsor's protocol ID
NN9388-7741
Other IDs
U1111-1300-2590, 2023-509600-15, 2023
Acronym
REIMAGINE 5
Status last verified
Oct 2026
First submitted
30 Jul 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 novonordisktrials.com

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cagrilintide, Semaglutide and Tirzepatide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 163 sites in 14 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 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 163 sites in United States, Canada, India, Hungary, Taiwan and 9 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 60)). 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 NCT06534411.

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.

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