A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight
REDEFINE 2
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
4 other identifiers
interventional
1,200
13 countries
179
Brief 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. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2023
179 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2022
CompletedFirst Posted
Study publicly available on registry
May 27, 2022
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 3, 2025
CompletedJanuary 28, 2026
January 1, 2026
2 years
May 24, 2022
January 26, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Relative change in body weight
Measured in percentage (%).
From baseline (week 0) to end of treatment (week 68)
Achievement of greater than or equal to (≥) 5% weight reduction
Count of participant.
From baseline (week 0) to end of treatment (week 68)
Secondary Outcomes (34)
Achievement of ≥ 20% weight reduction
From baseline (week 0) to end of treatment (week 68)
Relative change in body weight
From baseline (week 0) to week 20
Change in waist circumference
From baseline (week 0) to end of treatment (week 68)
Change in Glycated Haemoglobin (HbA1c)
From baseline (week 0) to end of treatment (week 68)
Change in Systolic Blood Pressure (SBP)
From baseline (week 0) to end of treatment (week 68)
- +29 more secondary outcomes
Study Arms (2)
CagriSema
EXPERIMENTALCagrilintide + semaglutide once weekly
Placebo
PLACEBO COMPARATORPlacebo cagrilintide + semaglutide once weekly
Interventions
Cagrilintide administered subcutaneously (s.c., under the skin) once-weekly
Placebo cagrilintide administered subcutaneously (s.c., under the skin) once-weekly
Placebo semaglutide administered subcutaneously (s.c., under the skin) once-weekly
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (179)
John Muir Physicians Network
Concord, California, 94520, United States
Headlands Research California, LLC
Escondido, California, 92025, United States
Providence Medical Foundation
Fullerton, California, 92835, United States
St. Jos Heritage Hlthcr_Fllrtn
Fullerton, California, 92835, United States
Diabetes/Lipid Mgmt & Res Ctr
Huntington Beach, California, 92648, United States
Clinical Trials Research
Lincoln, California, 95648, United States
Velocity Clin Res Los Angeles
Los Angeles, California, 90017, United States
Velocity Clin Res Wstlke
Los Angeles, California, 90057, United States
Desert Oasis Hlthcr Med Group
Palm Springs, California, 92262, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
New West Physicians,Inc.
Golden, Colorado, 80401, United States
Clinical Res Of W Florida Inc
Clearwater, Florida, 33765, United States
Northeast Research Institute
Fleming Island, Florida, 32003, United States
Jacksonville Ctr For Clin Res
Jacksonville, Florida, 32216, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
AdventHealth Diab Inst
Orlando, Florida, 32804, United States
Florida Institute for Clinical Research, LLC
Orlando, Florida, 32825, United States
Oviedo Medical Research, LLC
Oviedo, Florida, 32765, United States
Endo Res Solutions Inc
Roswell, Georgia, 30076, United States
East West Med Res Inst
Honolulu, Hawaii, 96814, United States
Cedar-Crosse Research Center
Chicago, Illinois, 60607, United States
Iowa Diab & Endo Res Center
West Des Moines, Iowa, 50266, United States
Cotton-Oneill Diabetes and End
Topeka, Kansas, 66606-2806, United States
L-MARC Research Center
Louisville, Kentucky, 40213, United States
Pennington Biom Res Ctr
Baton Rouge, Louisiana, 70808, United States
Northern Pines Hlth Ctr, PC
Buckley, Michigan, 49620, United States
International Diabetes Center
Minneapolis, Minnesota, 55416, United States
StudyMetrix Research LLC
City of Saint Peters, Missouri, 63303, United States
Mercury Str Med Grp, PLLC
Butte, Montana, 59701, United States
AMC Community Endocrinology
Albany, New York, 12203, United States
Southgate Medical Group, LLP
West Seneca, New York, 14224, United States
Great Lakes Medical Research
Westfield, New York, 14787, United States
PharmQuest Life Sciences LLC
Greensboro, North Carolina, 27408, United States
Hillcrest Clinical Research
Simpsonville, South Carolina, 29681-1538, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Amarillo Med Spec LLP
Amarillo, Texas, 79106, United States
Texas Diab & Endo, P.A.
Austin, Texas, 78731, United States
Texas Diab & Endo, P.A.
Austin, Texas, 78749, United States
Velocity Clinical Res-Dallas
Dallas, Texas, 75230, United States
North Texas Endocrine Center
Dallas, Texas, 75231, United States
UT Southwestern Med Cntr
Dallas, Texas, 75390-9302, United States
PlanIt Research, PLLC
Houston, Texas, 77079, United States
DCOL Ctr for Clin Res
Longview, Texas, 75605, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
Chrysalis Clinical Research
St. George, Utah, 84790, United States
National Clin Res Inc.
Richmond, Virginia, 23294, United States
Selma Medical Associates
Winchester, Virginia, 22601-3834, United States
Amherst Family Practice P.C.
Winchester, Virginia, 22601, United States
Capital Clin Res Ctr,LLC
Olympia, Washington, 98502, United States
Universitätsklinik für Innere Medizin Graz
Graz, 8036, Austria
Barmh. Brüder Linz, Konventspital
Linz, 4021, Austria
Fließer-Görzer [Ordination]
Saint Stefan, 8511, Austria
Klinik Landstraße
Vienna, 1030, Austria
Universitätsklinikum AKH Wien
Vienna, 1090, Austria
Imed 19- privat
Vienna, 1190, Austria
LMC Clin Res Inc. Calgary
Calgary, Alberta, T2H 2G4, Canada
C-endo Diab Endo Clin Calgery
Calgary, Alberta, T2V 4J2, Canada
Dr. M.B. Jones Inc
Victoria, British Columbia, V8V 4A1, Canada
Commonwealth Medical Clinic
Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada
Dr. Harpreet Bajaj
Brampton, Ontario, L6S 0C6, Canada
Centricity Research Etobicoke Endocrinology
Etobicoke, Ontario, M9R 4E1, Canada
Wharton Med Clin Trials
Hamilton, Ontario, L8L 5G8, Canada
Milestone Research
London, Ontario, N5W 6A2, Canada
LMC Research Inc. Ottawa
Nepean, Ontario, K2J 0V2, Canada
Diabetes Heart Research Centre
Toronto, Ontario, M6G 1M2, Canada
Centre Medical Acadie
Montreal, Quebec, H4N 2W2, Canada
Centricity Res Pointe-Claire
Pointe-Claire, Quebec, H9R 4S3, Canada
LMC Clin Rsrch Inc. (Montreal)
Saint-Laurent, Quebec, H4T 1Z9, Canada
Diabetespraxis Mergentheim
Bad Mergentheim, 97980, Germany
Zentrum fuer klinische Studien Suedbrandenburg GmbH
Elsterwerda, 04910, Germany
InnoDiab Forschung GmbH
Essen, 45136, Germany
Universitätsklinikum Freiburg - Innere Medizin II
Freiburg im Breisgau, 79106, Germany
Wendisch - Dahl Hamburg - DZHW
Hamburg, 22607, Germany
AmBeNet GmbH
Leipzig, 04107, Germany
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
Münster, 48145, Germany
Zentrum für klinische Studien Alexander Segner
Saint Ingbert-Oberwürzbach, 66386, Germany
MZM Praxis Drs. Erlinger
Stuttgart, 70378, Germany
Zentrum für klinische Studien Allgäu Oberschwaben
Wangen, 88239, Germany
Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
Szeged, Csongrád-Csanád, 6725, Hungary
Debreceni Egyetem Belgyógyászati Klinika
Debrecen, Hajdú-Bihar, 4032, Hungary
Hetényi Géza Kórház
Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary
Komáromi Selye János Kórház
Komárom, Komárom-Esztergom, 2900, Hungary
Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.
Budapest, 1033, Hungary
Szőcs Depot Egészségügyi Szolgáltató Kft.
Budapest, 1042, Hungary
Bajcsy-Zsilinszky Kórház
Budapest, 1106, Hungary
Selye János Kórház és Rendelőintézet
Komárom, 2900, Hungary
Hetényi Géza Kórház
Szolnok, 5004, Hungary
HCG Hospitals
Ahmedabad, Gujarat, 380006, India
Ramaiah Memorial Hospital
Bangalore, Karnataka, 560054, India
Calicut Medical College
Kozhikode, Kerala, 673008, India
Indian Institute of Diabetes
Thiruvnanthapuram, Kerala, 695033, India
Excel Endocrine Centre
Kolhāpur, Maharashtra, 416008, India
BYL Nair Hospital and T N Medical College Department of endo
Mumbai, Maharashtra, 400008, India
Seth GS medical college and KEM Hospital
Mumbai, Maharashtra, 400012, India
Sunil's Diabetes Care n' Research Centre Pvt Ltd
Nagpur, Maharashtra, 440010, India
Noble Hospitals Pvt Ltd.
Pune, Maharashtra, 411013, India
All India Institute of Medical Sciences_Delhi
Ansārinagar, New Delhi, 110029, India
Post Graduate Institute of Medical Education & Research_Chandigarh
Chandigarh, Punjab, 160012, India
J K Lon Hospital, SMS Medical College & Attached Hospitals
Jaipur, Rajasthan, 302004, India
SMS Medical College & Hospital
Jaipur, Rajasthan, 302004, India
Apollo Research & Innovation (ARI)
Chennai, Tamil Nadu, 600006, India
Madras Diabetes Research Foundation
Chennai, Tamil Nadu, 600086, India
Gleneagles Hospitals
Hyderabad, Telangana, 500004, India
Apollo Multispeciality Hospital, Kolkata
Kolkata, West Bengal, 700054, India
Apollo Multispeciality Hospitals Limited
Kolkata, West Bengal, 700054, India
Sunil's Diabetes Care n' Research Centre Pvt Ltd
Nagpur, 440010, India
Lady Hardinge Medical College
New Delhi, 110001, India
CRF - Galway
Galway, Connaght, H91 YR71, Ireland
CRF HRB - Galway
Galway, Connaght, H91 YR71, Ireland
Clinical Research Centre, St. Vincent's University Hospital,
Dublin, Leinster, D04 T6F4, Ireland
Mater Miscericordiae Hospital
Dublin, Leinster, D07 XAO9, Ireland
St James's CRF
Dublin, Leinster, D08 A978, Ireland
Connolly Hospital_Blanchardstown_Diabetes Day Centre
Dublin, Leinster, D15 X40D, Ireland
Connolly Hospital
Dublin, Leinster, DUBLIN 15, Ireland
Mater Miscericordiae Hospital
Dublin, Leinster, DUBLIN 7, Ireland
TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
Aichi, 468-0009, Japan
Tokuyama clinic_Diabetic internal medicine
Chiba, 261-0004, Japan
Naka Kinen Clinic_Internal medicine
Ibaraki, 311-0113, Japan
Osaka Nishiumeda Clinic_Diabetes Internal Medicine
Osaka, 530-0001, Japan
Osaka University Hospital_Metabolic Medicine
Osaka, 565-0871, Japan
Takatsuki Red Cross Hospital
Osaka, 569-1045, Japan
Hospital Universiti Sains Malaysia
Kota Bharu, Kelantan, 16150, Malaysia
Hospital Canselor Tuanku Muhriz UKM
Cheras, Kuala Lumpur, 56000, Malaysia
Hospital Seri Manjung
Seri Manjung, Perak, 32040, Malaysia
Hospital Putrajaya
Putrajaya, Putrajaya, 62250, Malaysia
Sarawak General Hospital
Kuching, Sarawak, 93586, Malaysia
Hospital Miri
Miri, Sarawak, 98000, Malaysia
Hospital Ampang
Ampang, Selangor, Selangor, 68000, Malaysia
University Technology MARA (UiTM) - Sg Buloh
Sungai Buloh, Selangor, 47000, Malaysia
Hospital Melaka
Malacca, 75400, Malaysia
Hospital Tuanku Jaafar
Seremban, 70300, Malaysia
Gierach-Med
Bygdoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland
Linden sp. z o.o. sp. k.
Krakow, Lesser Poland Voivodeship, 30-721, Poland
Beata Miklaszewicz & Dariusz Dabrowski "CARDIAMED" s.j.
Legnica, Lower Silesian Voivodeship, 59-220, Poland
Terpa Sp. z o.o. Sp. k.
Lublin, Lubelskie Voivodeship, 20-333, Poland
Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orłowskiego Centrum Medycznego Kształcenia Podyplomowego
Warsaw, Masovian Voivodeship, 00-416, Poland
Medical Concierge Centrum Medyczne
Warsaw, Masovian Voivodeship, 02-798, Poland
Instytut Diabetologii Sp. z o.o.
Warsaw, Mazovian Voivodeship, 02-117, Poland
Instytut Diabetologii Sp. z o.o.
Warsaw, Mazovian, 02-117, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Podlaskie Voivodeship, 15-276, Poland
Gabinet Leczenia Otylosci i Chorob Dietozaleznych
Bialystok, Podlaskie Voivodeship, 15-281, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, 80-214, Poland
Centrum Medyczne Salvia
Katowice, Slaskie Voivodeship, 40-772, Poland
Klinika Bellamed
Elblag, Warmian-Masurian Voivodeship, 82-300, Poland
Centrum Zdrowia Metabolicznego
Poznan, Wielkopolskie Voivodeship, 60-589, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15-276, Poland
Gierach-Med
Bygdoszcz, 85-796, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952, Poland
Linden sp. z o.o. sp. k.
Krakow, 30-721, Poland
Terpa Sp. z o.o. Sp. k.
Lublin, 20-333, Poland
Trialmed CRS
Piotrkow Trybunalski, Łódź Voivodeship, 97-300, Poland
Ponce Med School Found Inc
Ponce, 00716, Puerto Rico
Siriraj Hospital_Bangkoknoi, Bangkok
Bangkoknoi, Bangkok, Bangkok, 10700, Thailand
Ramathibodi Hospital
Bangkok, Ratchathewi Bangkok, 10400, Thailand
King Chulalongkorn Memorial Hospital_Bangkok
Bangkok, 10330, Thailand
King Chulalongkorn Memorial Hospital_Endocrinology
Bangkok, 10330, Thailand
Rajavithi Hospital_Diabetes and Endocrinology
Bangkok, 10400, Thailand
Rajavithi Hospital
Bangkok, 10400, Thailand
Ramathibodi Hospital
Bangkok, 10400, Thailand
Siriraj Hospital_Dept Endocrinology
Bangkok, 10700, Thailand
Srinagarind Hospital
Khon Kaen, 40002, Thailand
Thammasat Hospital_Cardiology
Pathum Thani, 12120, Thailand
Harrogate District Hospital
Harrogate, North Yorkshire, HG2 7SX, United Kingdom
Crouch Oak Family Practice
Addlestone, Surrey, KT15 2BH, United Kingdom
Antrim Area Hospital
Antrim, BT42 2RL, United Kingdom
Layton Medical Centre
Blackpool, FY3 7EN, United Kingdom
The Health Centre
Bradford-on-Avon, BA15 1DQ, United Kingdom
Southmead Hospital
Bristol, BS10 5NB, United Kingdom
Hathaway Medical Centre
Chippenham, SN14 6GT, United Kingdom
HMC Health - Heston
Hounslow, TW5 9ER, United Kingdom
Leicester General Hospital
Leicester, LE5 4PW, United Kingdom
Kiltearn Medical Centre
Nantwich, CW5 5NX, United Kingdom
Clifton Medical Centre
Rotherham, S65 1DA, United Kingdom
Ashfields Primary Care Centre
Sandbach, CW11 1EQ, United Kingdom
Staploe Medical Centre
Soham, CB7 5JD, United Kingdom
Joint Clinical Research Facility - Swansea
Swansea, SA2 8PP, United Kingdom
Musgrove Park Hospital
Taunton, TA1 5DA, United Kingdom
Royal Cornwall Hospital (Treliske)
Truro, TR1 3LJ, United Kingdom
Albany House Medical Centre
Wellingborough, NN8 4RW, United Kingdom
Related Publications (1)
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.
PMID: 40544432DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2022
First Posted
May 27, 2022
Study Start
February 1, 2023
Primary Completion
January 28, 2025
Study Completion
February 3, 2025
Last Updated
January 28, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"