AzTrials
AzTrials

OverweightPhase 3REDEFINE 2NCT05394519

A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight

A Phase 3 study testing Cagrilintide and Semaglutide in people with Overweight and Obesity, run by Novo Nordisk A/S at 179 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will look at how well the new medicine CagriSema helps people living with excess body weight and type 2 diabetes losing weight. Participants will either get CagriSema or a dummy medicine. Which treatment they get is decided by chance. The study will last for about 1½ years. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Overweight, Obesity, Type 2 Diabetes Mellitus
What is being tested?
Cagrilintide and Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,200 participants
Where
179 sitesin 13 countries
Study dates
1 Feb 2023to 3 Feb 2025
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
  • Age above or equal to 18 years at the time of signing informed consent
  • BMI greather than or equal to 27.0 kg/m^2
  • Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening
  • Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulphonylureas (SU)s as a single agent or in combination) according to local label
  • Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening
  • HbA1c 7%-10% (53-86 mmol/mol) (both inclusive) as measured by the central laboratory at screening

Who cannot join

  • Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness
  • Renal impairment with estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m^2, as measured by the central laboratory at screening
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus 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

179 sites in 13 countries.

179 sites in 13 countries

United States49 sites

  • AMC Community Endocrinology

    Albany, New York, 12203

  • Amarillo Med Spec LLP

    Amarillo, Texas, 79106

  • Texas Diab & Endo, P.A.

    Austin, Texas, 78731

  • Texas Diab & Endo, P.A.

    Austin, Texas, 78749

  • Pennington Biom Res Ctr

    Baton Rouge, Louisiana, 70808

  • Northern Pines Hlth Ctr, PC

    Buckley, Michigan, 49620

  • Mercury Str Med Grp, PLLC

    Butte, Montana, 59701

  • Cedar-Crosse Research Center

    Chicago, Illinois, 60607

  • StudyMetrix Research LLC

    City of Saint Peters, Missouri, 63303

  • Clinical Res Of W Florida Inc

    Clearwater, Florida, 33765

  • John Muir Physicians Network

    Concord, California, 94520

  • Velocity Clinical Res-Dallas

    Dallas, Texas, 75230

  • North Texas Endocrine Center

    Dallas, Texas, 75231

  • UT Southwestern Med Cntr

    Dallas, Texas, 75390-9302

  • Headlands Research California, LLC

    Escondido, California, 92025

  • Northeast Research Institute

    Fleming Island, Florida, 32003

  • Providence Medical Foundation

    Fullerton, California, 92835

  • St. Jos Heritage Hlthcr_Fllrtn

    Fullerton, California, 92835

  • New West Physicians,Inc.

    Golden, Colorado, 80401

  • PharmQuest Life Sciences LLC

    Greensboro, North Carolina, 27408

  • East West Med Res Inst

    Honolulu, Hawaii, 96814

  • PlanIt Research, PLLC

    Houston, Texas, 77079

  • Diabetes/Lipid Mgmt & Res Ctr

    Huntington Beach, California, 92648

  • Jacksonville Ctr For Clin Res

    Jacksonville, Florida, 32216

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Clinical Trials Research

    Lincoln, California, 95648

  • DCOL Ctr for Clin Res

    Longview, Texas, 75605

  • Velocity Clin Res Los Angeles

    Los Angeles, California, 90017

  • Velocity Clin Res Wstlke

    Los Angeles, California, 90057

  • L-MARC Research Center

    Louisville, Kentucky, 40213

  • International Diabetes Center

    Minneapolis, Minnesota, 55416

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Capital Clin Res Ctr,LLC

    Olympia, Washington, 98502

  • AdventHealth Diab Inst

    Orlando, Florida, 32804

  • Florida Institute for Clinical Research, LLC

    Orlando, Florida, 32825

  • Oviedo Medical Research, LLC

    Oviedo, Florida, 32765

  • Desert Oasis Hlthcr Med Group

    Palm Springs, California, 92262

  • National Clin Res Inc.

    Richmond, Virginia, 23294

  • Endo Res Solutions Inc

    Roswell, Georgia, 30076

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

  • Hillcrest Clinical Research

    Simpsonville, South Carolina, 29681-1538

  • Chrysalis Clinical Research

    St. George, Utah, 84790

  • Cotton-Oneill Diabetes and End

    Topeka, Kansas, 66606-2806

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • Iowa Diab & Endo Res Center

    West Des Moines, Iowa, 50266

  • Southgate Medical Group, LLP

    West Seneca, New York, 14224

  • Great Lakes Medical Research

    Westfield, New York, 14787

  • Selma Medical Associates

    Winchester, Virginia, 22601-3834

  • Amherst Family Practice P.C.

    Winchester, Virginia, 22601

Other trials in United States

India20 sites

  • HCG Hospitals

    Ahmedabad, Gujarat, 380006

  • All India Institute of Medical Sciences_Delhi

    Ansārinagar, New Delhi, 110029

  • Ramaiah Memorial Hospital

    Bangalore, Karnataka, 560054

  • Post Graduate Institute of Medical Education & Research_Chandigarh

    Chandigarh, Punjab, 160012

  • Apollo Research & Innovation (ARI)

    Chennai, Tamil Nadu, 600006

  • Madras Diabetes Research Foundation

    Chennai, Tamil Nadu, 600086

  • Gleneagles Hospitals

    Hyderabad, Telangana, 500004

  • J K Lon Hospital, SMS Medical College & Attached Hospitals

    Jaipur, Rajasthan, 302004

  • SMS Medical College & Hospital

    Jaipur, Rajasthan, 302004

  • Excel Endocrine Centre

    Kolhāpur, Maharashtra, 416008

  • Apollo Multispeciality Hospital, Kolkata

    Kolkata, West Bengal, 700054

  • Apollo Multispeciality Hospitals Limited

    Kolkata, West Bengal, 700054

  • Calicut Medical College

    Kozhikode, Kerala, 673008

  • BYL Nair Hospital and T N Medical College Department of endo

    Mumbai, Maharashtra, 400008

  • Seth GS medical college and KEM Hospital

    Mumbai, Maharashtra, 400012

  • Sunil's Diabetes Care n' Research Centre Pvt Ltd

    Nagpur, Maharashtra, 440010

  • Sunil's Diabetes Care n' Research Centre Pvt Ltd

    Nagpur, 440010

  • Lady Hardinge Medical College

    New Delhi, 110001

  • Noble Hospitals Pvt Ltd.

    Pune, Maharashtra, 411013

  • Indian Institute of Diabetes

    Thiruvnanthapuram, Kerala, 695033

Other trials in India

Poland20 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, Podlaskie Voivodeship, 15-276

  • Gabinet Leczenia Otylosci i Chorob Dietozaleznych

    Bialystok, Podlaskie Voivodeship, 15-281

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276

  • Gierach-Med

    Bygdoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Gierach-Med

    Bygdoszcz, 85-796

  • Klinika Bellamed

    Elblag, Warmian-Masurian Voivodeship, 82-300

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Pomeranian Voivodeship, 80-214

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Centrum Medyczne Salvia

    Katowice, Slaskie Voivodeship, 40-772

  • Linden sp. z o.o. sp. k.

    Krakow, Lesser Poland Voivodeship, 30-721

  • Linden sp. z o.o. sp. k.

    Krakow, 30-721

  • Beata Miklaszewicz & Dariusz Dabrowski "CARDIAMED" s.j.

    Legnica, Lower Silesian Voivodeship, 59-220

  • Terpa Sp. z o.o. Sp. k.

    Lublin, Lubelskie Voivodeship, 20-333

  • Terpa Sp. z o.o. Sp. k.

    Lublin, 20-333

  • Trialmed CRS

    Piotrkow Trybunalski, Łódź Voivodeship, 97-300

  • Centrum Zdrowia Metabolicznego

    Poznan, Wielkopolskie Voivodeship, 60-589

  • Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orłowskiego Centrum Medycznego Kształcenia Podyplomowego

    Warsaw, Masovian Voivodeship, 00-416

  • Medical Concierge Centrum Medyczne

    Warsaw, Masovian Voivodeship, 02-798

  • Instytut Diabetologii Sp. z o.o.

    Warsaw, Mazovian Voivodeship, 02-117

  • Instytut Diabetologii Sp. z o.o.

    Warsaw, Mazovian, 02-117

Other trials in Poland

United Kingdom17 sites

  • Crouch Oak Family Practice

    Addlestone, Surrey, KT15 2BH

  • Antrim Area Hospital

    Antrim, BT42 2RL

  • Layton Medical Centre

    Blackpool, FY3 7EN

  • The Health Centre

    Bradford on Avon, BA15 1DQ

  • Southmead Hospital

    Bristol, BS10 5NB

  • Hathaway Medical Centre

    Chippenham, SN14 6GT

  • Harrogate District Hospital

    Harrogate, North Yorkshire, HG2 7SX

  • HMC Health - Heston

    Hounslow, TW5 9ER

  • Leicester General Hospital

    Leicester, LE5 4PW

  • Kiltearn Medical Centre

    Nantwich, CW5 5NX

  • Clifton Medical Centre

    Rotherham, S65 1DA

  • Ashfields Primary Care Centre

    Sandbach, CW11 1EQ

  • Staploe Medical Centre

    Soham, CB7 5JD

  • Joint Clinical Research Facility - Swansea

    Swansea, SA2 8PP

  • Musgrove Park Hospital

    Taunton, TA1 5DA

  • Royal Cornwall Hospital (Treliske)

    Truro, TR1 3LJ

  • Albany House Medical Centre

    Wellingborough, NN8 4RW

Other trials in United Kingdom

Canada13 sites

  • Dr. Harpreet Bajaj

    Brampton, Ontario, L6S 0C6

  • LMC Clin Res Inc. Calgary

    Calgary, Alberta, T2H 2G4

  • C-endo Diab Endo Clin Calgery

    Calgary, Alberta, T2V 4J2

  • Centricity Research Etobicoke Endocrinology

    Etobicoke, Ontario, M9R 4E1

  • Wharton Med Clin Trials

    Hamilton, Ontario, L8L 5G8

  • Milestone Research

    London, Ontario, N5W 6A2

  • Centre Medical Acadie

    Montreal, Quebec, H4N 2W2

  • Commonwealth Medical Clinic

    Mount Pearl, Newfoundland and Labrador, A1N 1W7

  • LMC Research Inc. Ottawa

    Nepean, Ontario, K2J 0V2

  • Centricity Res Pointe-Claire

    Pointe-Claire, Quebec, H9R 4S3

  • LMC Clin Rsrch Inc. (Montreal)

    Saint-Laurent, Quebec, H4T 1Z9

  • Diabetes Heart Research Centre

    Toronto, Ontario, M6G 1M2

  • Dr. M.B. Jones Inc

    Victoria, British Columbia, V8V 4A1

Other trials in Canada

Germany10 sites

  • Diabetespraxis Mergentheim

    Bad Mergentheim, 97980

  • Zentrum fuer klinische Studien Suedbrandenburg GmbH

    Elsterwerda, 04910

  • InnoDiab Forschung GmbH

    Essen, 45136

  • Universitätsklinikum Freiburg - Innere Medizin II

    Freiburg im Breisgau, 79106

  • Wendisch - Dahl Hamburg - DZHW

    Hamburg, 22607

  • AmBeNet GmbH

    Leipzig, 04107

  • Institut für Diabetesforschung GmbH Münster - Dr. med. Rose

    Münster, 48145

  • Zentrum für klinische Studien Alexander Segner

    Saint Ingbert-Oberwürzbach, 66386

  • MZM Praxis Drs. Erlinger

    Stuttgart, 70378

  • Zentrum für klinische Studien Allgäu Oberschwaben

    Wangen, 88239

Other trials in Germany

Malaysia10 sites

  • Hospital Ampang

    Ampang, Selangor, Selangor, 68000

  • Hospital Canselor Tuanku Muhriz UKM

    Cheras, Kuala Lumpur, 56000

  • Hospital Universiti Sains Malaysia

    Kota Bharu, Kelantan, 16150

  • Sarawak General Hospital

    Kuching, Sarawak, 93586

  • Hospital Melaka

    Malacca, 75400

  • Hospital Miri

    Miri, Sarawak, 98000

  • Hospital Putrajaya

    Putrajaya, Putrajaya, 62250

  • Hospital Tuanku Jaafar

    Seremban, 70300

  • Hospital Seri Manjung

    Seri Manjung, Perak, 32040

  • University Technology MARA (UiTM) - Sg Buloh

    Sungai Buloh, Selangor, 47000

Other trials in Malaysia

Thailand10 sites

  • Ramathibodi Hospital

    Bangkok, Ratchathewi Bangkok, 10400

  • King Chulalongkorn Memorial Hospital_Bangkok

    Bangkok, 10330

  • King Chulalongkorn Memorial Hospital_Endocrinology

    Bangkok, 10330

  • Rajavithi Hospital_Diabetes and Endocrinology

    Bangkok, 10400

  • Rajavithi Hospital

    Bangkok, 10400

  • Ramathibodi Hospital

    Bangkok, 10400

  • Siriraj Hospital_Dept Endocrinology

    Bangkok, 10700

  • Siriraj Hospital_Bangkoknoi, Bangkok

    Bangkoknoi, Bangkok, Bangkok, 10700

  • Srinagarind Hospital

    Khon Kaen, 40002

  • Thammasat Hospital_Cardiology

    Pathum Thani, 12120

Other trials in Thailand

Hungary9 sites

  • Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.

    Budapest, 1033

  • Szőcs Depot Egészségügyi Szolgáltató Kft.

    Budapest, 1042

  • Bajcsy-Zsilinszky Kórház

    Budapest, 1106

  • Debreceni Egyetem Belgyógyászati Klinika

    Debrecen, Hajdú-Bihar, 4032

  • Komáromi Selye János Kórház

    Komárom, Komárom-Esztergom, 2900

  • Selye János Kórház és Rendelőintézet

    Komárom, 2900

  • Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ

    Szeged, Csongrád-Csanád, 6725

  • Hetényi Géza Kórház

    Szolnok, Jász-Nagykun-Szolnok, 5000

  • Hetényi Géza Kórház

    Szolnok, 5004

Other trials in Hungary

Ireland8 sites

  • Clinical Research Centre, St. Vincent's University Hospital,

    Dublin, Leinster, D04 T6F4

  • Mater Miscericordiae Hospital

    Dublin, Leinster, D07 XAO9

  • St James's CRF

    Dublin, Leinster, D08 A978

  • Connolly Hospital_Blanchardstown_Diabetes Day Centre

    Dublin, Leinster, D15 X40D

  • Connolly Hospital

    Dublin, Leinster, DUBLIN 15

  • Mater Miscericordiae Hospital

    Dublin, Leinster, DUBLIN 7

  • CRF - Galway

    Galway, Connaght, H91 YR71

  • CRF HRB - Galway

    Galway, Connaght, H91 YR71

Other trials in Ireland

Austria6 sites

  • Universitätsklinik für Innere Medizin Graz

    Graz, 8036

  • Barmh. Brüder Linz, Konventspital

    Linz, 4021

  • Fließer-Görzer [Ordination]

    Saint Stefan, 8511

  • Klinik Landstraße

    Vienna, 1030

  • Universitätsklinikum AKH Wien

    Vienna, 1090

  • Imed 19- privat

    Vienna, 1190

Other trials in Austria

Japan6 sites

  • TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology

    Aichi, 468-0009

  • Tokuyama clinic_Diabetic internal medicine

    Chiba, 261-0004

  • Naka Kinen Clinic_Internal medicine

    Ibaraki, 311-0113

  • Osaka Nishiumeda Clinic_Diabetes Internal Medicine

    Osaka, 530-0001

  • Osaka University Hospital_Metabolic Medicine

    Osaka, 565-0871

  • Takatsuki Red Cross Hospital

    Osaka, 569-1045

Other trials in Japan

Puerto Rico1 site

  • Ponce Med School Found Inc

    Ponce, 00716

Other trials in Puerto Rico

About this study

Official title: Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly in Participants With Overweight or Obesity and Type 2 Diabetes

This study will look at how well the new medicine CagriSema helps people living with excess body weight and type 2 diabetes losing weight. Participants will either get CagriSema or a dummy medicine. Which treatment they get is decided by chance.

The study will last for about 1½ years. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.

Being tested
Cagrilintide, Semaglutide, Placebo cagrilintide, Placebo semaglutide
Medical subject headings
Overweight, Obesity, 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 administered subcutaneously (s.c., under the skin) once-weekly

  • SemaglutideDrug

    Semaglutide administered subcutaneously (s.c., under the skin) once-weekly

  • Placebo cagrilintideDrug

    Placebo cagrilintide administered subcutaneously (s.c., under the skin) once-weekly

  • Placebo semaglutideDrug

    Placebo semaglutide administered subcutaneously (s.c., under the skin) once-weekly

Study groups in NCT05394519
Study groupRoleWhat they receive
CagriSemaExperimentalCagrilintide + semaglutide once weekly
Receives: Drug: Cagrilintide; Drug: Semaglutide
PlaceboPlacebo comparatorPlacebo cagrilintide + semaglutide once weekly
Receives: Drug: Placebo cagrilintide; Drug: Placebo semaglutide

What is being measured

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

  1. Relative change in body weight

    Measured in percentage (%).

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

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

    Count of participant.

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

Secondary outcomes (34)

  1. Achievement of ≥ 20% weight reduction

    Count of participant.

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

  2. Relative change in body weight

    Measured in %.

    Measured: From baseline (week 0) to week 20

  3. Change in waist circumference

    Measured in centimeter (cm).

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

  4. Change in Glycated Haemoglobin (HbA1c)

    Measured in %-points.

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

  5. Change in Systolic Blood Pressure (SBP)

    Measured in millimeter of mercury (mmHg).

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

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

    Measured in score points.

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

  7. Change in Short Form-36 Version 2.0 Health Survey Acute (SF-36v2 Acute) Physical Functioning score

    Measured in score points.

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

  8. Change in body weight

    Measured in kilogram (kg).

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

  9. Change in body mass index (BMI)

    Measured in kilogram per meter square (kg/m^2).

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

  10. Improvement in weight category (BMI, underweight below 18.5, normal weight 18.5 to below 25, overweight 25.0 to below 30, obesity class I 30 to below 35, obesity class II 35 to below 40, obesity class III above 40)

    Count of participant.

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

  11. Achievement of HbA1c less than or equal to (≤) 6.5%

    Count of participant.

    Measured: At end of treatment (week 68)

  12. Change in Fasting Plasma Glucose (mmol/L)

    Measured in millimoles per liter (mmol/L).

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

  13. Change in Fasting Plasma Glucose (mg/dL)

    Measured in milligram per deciliter (mg/dL)

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

  14. Ratio to baseline in fasting serum insulin

    Measured in ratio.

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

  15. Change in Diastolic Blood Pressure (DBP)

    Measured in mmHg.

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

  16. Ratio to baseline in C-reactive protein (CRP)

    Measured in ratio.

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

  17. Ratio to baseline in lipids: Total cholesterol, High-density lipoprotein (HDL) cholesterol, Low-density lipoprotein (LDL) cholesterol, Very low-density lipoprotein (VLDL) cholesterol, Triglycerides and Free fatty acids

    Measured in ratio.

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

  18. Change in IWQOL-Lite-CT: Total score, Physical and Psycosocial score

    IWQOL-Lite-CT is a 20-item clinical outcomes assessment (COA) instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score. Score ranges for composite score (physical composite, psychosocial composite and physical function composite) and Total score is 0-100. Higher scores indicate better level of functioning.

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

  19. Change in Control of Eating Questionnaire (CoEQ): Craving Control score, Positive Mood score, Craving for Sweet score, Craving for Savoury food score, Hunger score and Satiety score

    CoEQ is a 19-item multidimensional patient-reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). Higher score represents a greater level of Craving Control.

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

  20. Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score

    Count of participant.

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

  21. Achievement of at least 3.7-point increase (yes/no) in SF-36v2 Acute Physical Functioning score

    Count of participant.

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

  22. Change in IWQOL-Lite-CT Physical Function score

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

  23. Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite -CT Physical Function score for subgroup

    Count of participant.

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

  24. Continuous glucose monitoring: Change in mean glucose (mmol/L)

    Measured in mmol/L.

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

  25. Continuous glucose monitoring: Change in mean glucose (mg/L)

    Measured in mg/L.

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

  26. CGM: Change in time above range (TAR) >10.0 mmol/L (>180 mg/dL)

    Measured in %-points.

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

  27. CGM: Change in time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL)

    Measured in %-points.

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

  28. CGM: Change in time above high range (TAHR) >13.9 mmol/L (>250 mg/dL)

    Measured in %-points.

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

  29. CGM: Change in time in tight range (TITR) 3.9-7.8 mmol/L (71-140 mg/dL)

    Measured in %-points.

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

  30. CGM: Within-day glycaemic variability (% CV)

    Measured in %.

    Measured: At end of treatment (week 68)

  31. Number of Treatment Emergent Adverse Events (TEAEs)

    Count of events.

    Measured: From baseline (week 0) to end of study (week 75)

  32. Number of Treatment Emergent Serious adverse events (TESAEs)

    Count of events.

    Measured: From baseline (week 0) to end of study (week 75)

  33. Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter)

    Count of episodes.

    Measured: From baseline (week 0) to end of study (week 75)

  34. 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 75)

Timeline

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

  1. First posted27 May 2022
  2. Study start1 Feb 2023
  3. Primary completion28 Jan 2025
  4. Study completion3 Feb 2025

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05394519
Sponsor's protocol ID
NN9838-4609
Other IDs
U1111-1267-4287, 2021-005121-24, jRCT2031220671
Acronym
REDEFINE 2
Status last verified
Jan 2026
First submitted
24 May 2022
Last updated
28 Jan 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"

Publications

  • Davies MJ, Bajaj HS, Broholm C, Eliasen A, Garvey WT, le Roux CW, Lingvay I, Lyndgaard CB, Rosenstock J, Pedersen SD; REDEFINE 2 Study Group. Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes. N Engl J Med. 2025 Aug 14;393(7):648-659. doi: 10.1056/NEJMoa2502082. Epub 2025 Jun 22.

    PubMed 40544432

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cagrilintide and Semaglutide in people with Overweight and Obesity, run by Novo Nordisk A/S at 179 sites in 13 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 7 inclusion and 3 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 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 179 sites in United States, India, Poland, United Kingdom, Canada and 8 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. Some participants in this study may receive a placebo. 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?

Relative change in body weight (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 NCT05394519, which also lists 1 linked publication.

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 28 Jan 2026.

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