New combo shot CagriSema shows promise for weight loss in type 2 diabetes

NCT ID NCT05394519

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

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested a new medicine called CagriSema, which combines two drugs (cagrilintide and semaglutide) in one weekly injection, for weight loss in 1200 adults who are overweight or obese and have type 2 diabetes. Participants received either CagriSema or a placebo for about 1.5 years. The main goals were to see how much weight they lost and how many achieved at least a 5% weight reduction.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: CagriSema (cagrilintide and semaglutide combination)
What this could lead to: If successful, this could offer a new once-weekly injection that helps people with type 2 diabetes and excess weight lose more weight than current options.
What could go wrong: This is a completed Phase 3 trial, but results are not yet published. The combination may cause side effects like nausea or vomiting, and not everyone may achieve significant weight loss.

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

Study facts

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

Phase

Phase 3

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

Participants

1,200 people

The number who actually took part.

Started

Feb 2023

Finished

Feb 2025

Lead sponsor

A company

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

Who can take part

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

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

Show the full entry requirements

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

Inclusion Criteria: * Male or female * 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 Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight type 2 diabetes mellitus

As listed by the trial registrant

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

Obesity Overweight Type 2 diabetes mellitus

Contacts and locations

Locations

AMC Community Endocrinology

Albany, New York, 12203, United States
AdventHealth Diab Inst

Orlando, Florida, 32804, United States
Albany House Medical Centre

Wellingborough, NN8 4RW, United Kingdom
All India Institute of Medical Sciences_Delhi

Ansārinagar, New Delhi, 110029, India
AmBeNet GmbH

Leipzig, 04107, Germany
Amarillo Med Spec LLP

Amarillo, Texas, 79106, United States
Amherst Family Practice P.C.

Winchester, Virginia, 22601, United States
Antrim Area Hospital

Antrim, BT42 2RL, United Kingdom
Apollo Multispeciality Hospital, Kolkata

Kolkata, West Bengal, 700054, India
Apollo Multispeciality Hospitals Limited

Kolkata, West Bengal, 700054, India
Apollo Research & Innovation (ARI)

Chennai, Tamil Nadu, 600006, India
Ashfields Primary Care Centre

Sandbach, CW11 1EQ, United Kingdom
BYL Nair Hospital and T N Medical College Department of endo

Mumbai, Maharashtra, 400008, India
Bajcsy-Zsilinszky Kórház

Budapest, 1106, Hungary
Barmh. Brüder Linz, Konventspital

Linz, 4021, Austria
Beata Miklaszewicz & Dariusz Dabrowski "CARDIAMED" s.j.

Legnica, Lower Silesian Voivodeship, 59-220, Poland
C-endo Diab Endo Clin Calgery

Calgary, Alberta, T2V 4J2, Canada
CRF - Galway

Galway, Connaght, H91 YR71, Ireland
CRF HRB - Galway

Galway, Connaght, H91 YR71, Ireland
Calicut Medical College

Kozhikode, Kerala, 673008, India
Capital Clin Res Ctr,LLC

Olympia, Washington, 98502, United States
Cedar-Crosse Research Center

Chicago, Illinois, 60607, United States
Centre Medical Acadie

Montreal, Quebec, H4N 2W2, Canada
Centricity Res Pointe-Claire

Pointe-Claire, Quebec, H9R 4S3, Canada
Centricity Research Etobicoke Endocrinology

Etobicoke, Ontario, M9R 4E1, Canada
Centrum Medyczne Salvia

Katowice, Slaskie Voivodeship, 40-772, Poland
Centrum Zdrowia Metabolicznego

Poznan, Wielkopolskie Voivodeship, 60-589, Poland
Chrysalis Clinical Research

St. George, Utah, 84790, United States
Clifton Medical Centre

Rotherham, S65 1DA, United Kingdom
Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.

Budapest, 1033, Hungary
Clinical Res Of W Florida Inc

Clearwater, Florida, 33765, United States
Clinical Research Centre, St. Vincent's University Hospital,

Dublin, Leinster, D04 T6F4, Ireland
Clinical Trials Research

Lincoln, California, 95648, United States
Commonwealth Medical Clinic

Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada
Connolly Hospital

Dublin, Leinster, DUBLIN 15, Ireland
Connolly Hospital_Blanchardstown_Diabetes Day Centre

Dublin, Leinster, D15 X40D, Ireland
Consano Clinical Research, LLC

Shavano Park, Texas, 78231, United States
Cotton-Oneill Diabetes and End

Topeka, Kansas, 66606-2806, United States
Crouch Oak Family Practice

Addlestone, Surrey, KT15 2BH, United Kingdom
DCOL Ctr for Clin Res

Longview, Texas, 75605, United States
Debreceni Egyetem Belgyógyászati Klinika

Debrecen, Hajdú-Bihar, 4032, Hungary
Desert Oasis Hlthcr Med Group

Palm Springs, California, 92262, United States
Diabetes Heart Research Centre

Toronto, Ontario, M6G 1M2, Canada
Diabetes/Lipid Mgmt & Res Ctr

Huntington Beach, California, 92648, United States
Diabetespraxis Mergentheim

Bad Mergentheim, 97980, Germany
Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States
Dr. Harpreet Bajaj

Brampton, Ontario, L6S 0C6, Canada
Dr. M.B. Jones Inc

Victoria, British Columbia, V8V 4A1, Canada
East West Med Res Inst

Honolulu, Hawaii, 96814, United States
Endo Res Solutions Inc

Roswell, Georgia, 30076, United States
Excel Endocrine Centre

Kolhāpur, Maharashtra, 416008, India
Fließer-Görzer [Ordination]

Saint Stefan, 8511, Austria
Florida Institute for Clinical Research, LLC

Orlando, Florida, 32825, United States
Gabinet Leczenia Otylosci i Chorob Dietozaleznych

Bialystok, Podlaskie Voivodeship, 15-281, Poland
Gierach-Med

Bygdoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland
Gierach-Med

Bygdoszcz, 85-796, Poland
Gleneagles Hospitals

Hyderabad, Telangana, 500004, India
Great Lakes Medical Research

Westfield, New York, 14787, United States
HCG Hospitals

Ahmedabad, Gujarat, 380006, India
HMC Health - Heston

Hounslow, TW5 9ER, United Kingdom
Harrogate District Hospital

Harrogate, North Yorkshire, HG2 7SX, United Kingdom
Hathaway Medical Centre

Chippenham, SN14 6GT, United Kingdom
Headlands Research California, LLC

Escondido, California, 92025, United States
Hetényi Géza Kórház

Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary
Hetényi Géza Kórház

Szolnok, 5004, Hungary
Hillcrest Clinical Research

Simpsonville, South Carolina, 29681-1538, United States
Holston Medical Group

Kingsport, Tennessee, 37660, United States
Hospital Ampang

Ampang, Selangor, Selangor, 68000, Malaysia
Hospital Canselor Tuanku Muhriz UKM

Cheras, Kuala Lumpur, 56000, Malaysia
Hospital Melaka

Malacca, 75400, Malaysia
Hospital Miri

Miri, Sarawak, 98000, Malaysia
Hospital Putrajaya

Putrajaya, Putrajaya, 62250, Malaysia
Hospital Seri Manjung

Seri Manjung, Perak, 32040, Malaysia
Hospital Tuanku Jaafar

Seremban, 70300, Malaysia
Hospital Universiti Sains Malaysia

Kota Bharu, Kelantan, 16150, Malaysia
Imed 19- privat

Vienna, 1190, Austria
Indian Institute of Diabetes

Thiruvnanthapuram, Kerala, 695033, India
InnoDiab Forschung GmbH

Essen, 45136, Germany
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose

Münster, 48145, Germany
Instytut Diabetologii Sp. z o.o.

Warsaw, Mazovian Voivodeship, 02-117, Poland
Instytut Diabetologii Sp. z o.o.

Warsaw, Mazovian, 02-117, Poland
International Diabetes Center

Minneapolis, Minnesota, 55416, United States
Iowa Diab & Endo Res Center

West Des Moines, Iowa, 50266, United States
J K Lon Hospital, SMS Medical College & Attached Hospitals

Jaipur, Rajasthan, 302004, India
Jacksonville Ctr For Clin Res

Jacksonville, Florida, 32216, United States
John Muir Physicians Network

Concord, California, 94520, United States
Joint Clinical Research Facility - Swansea

Swansea, SA2 8PP, United Kingdom
Kiltearn Medical Centre

Nantwich, CW5 5NX, United Kingdom
King Chulalongkorn Memorial Hospital_Bangkok

Bangkok, 10330, Thailand
King Chulalongkorn Memorial Hospital_Endocrinology

Bangkok, 10330, Thailand
Klinik Landstraße

Vienna, 1030, Austria
Klinika Bellamed

Elblag, Warmian-Masurian Voivodeship, 82-300, Poland
Komáromi Selye János Kórház

Komárom, Komárom-Esztergom, 2900, Hungary
L-MARC Research Center

Louisville, Kentucky, 40213, United States
LMC Clin Res Inc. Calgary

Calgary, Alberta, T2H 2G4, Canada
LMC Clin Rsrch Inc. (Montreal)

Saint-Laurent, Quebec, H4T 1Z9, Canada
LMC Research Inc. Ottawa

Nepean, Ontario, K2J 0V2, Canada
Lady Hardinge Medical College

New Delhi, 110001, India
Layton Medical Centre

Blackpool, FY3 7EN, United Kingdom
Leicester General Hospital

Leicester, LE5 4PW, United Kingdom
Linden sp. z o.o. sp. k.

Krakow, Lesser Poland Voivodeship, 30-721, Poland
Linden sp. z o.o. sp. k.

Krakow, 30-721, Poland
MZM Praxis Drs. Erlinger

Stuttgart, 70378, Germany
Madras Diabetes Research Foundation

Chennai, Tamil Nadu, 600086, India
Mater Miscericordiae Hospital

Dublin, Leinster, D07 XAO9, Ireland
Mater Miscericordiae Hospital

Dublin, Leinster, DUBLIN 7, Ireland
Medical Concierge Centrum Medyczne

Warsaw, Masovian Voivodeship, 02-798, Poland
Mercury Str Med Grp, PLLC

Butte, Montana, 59701, United States
Milestone Research

London, Ontario, N5W 6A2, Canada
Musgrove Park Hospital

Taunton, TA1 5DA, United Kingdom
Naka Kinen Clinic_Internal medicine

Ibaraki, 311-0113, Japan
National Clin Res Inc.

Richmond, Virginia, 23294, United States
New West Physicians,Inc.

Golden, Colorado, 80401, United States
Noble Hospitals Pvt Ltd.

Pune, Maharashtra, 411013, India
North Texas Endocrine Center

Dallas, Texas, 75231, United States
Northeast Research Institute

Fleming Island, Florida, 32003, United States
Northern Pines Hlth Ctr, PC

Buckley, Michigan, 49620, United States
Osaka Nishiumeda Clinic_Diabetes Internal Medicine

Osaka, 530-0001, Japan
Osaka University Hospital_Metabolic Medicine

Osaka, 565-0871, Japan
Oviedo Medical Research, LLC

Oviedo, Florida, 32765, United States
Pennington Biom Res Ctr

Baton Rouge, Louisiana, 70808, United States
PharmQuest Life Sciences LLC

Greensboro, North Carolina, 27408, United States
PlanIt Research, PLLC

Houston, Texas, 77079, United States
Ponce Med School Found Inc

Ponce, 00716, Puerto Rico
Post Graduate Institute of Medical Education & Research_Chandigarh

Chandigarh, Punjab, 160012, India
Providence Medical Foundation

Fullerton, California, 92835, United States
Rajavithi Hospital

Bangkok, 10400, Thailand
Rajavithi Hospital_Diabetes and Endocrinology

Bangkok, 10400, Thailand
Ramaiah Memorial Hospital

Bangalore, Karnataka, 560054, India
Ramathibodi Hospital

Bangkok, Ratchathewi Bangkok, 10400, Thailand
Ramathibodi Hospital

Bangkok, 10400, Thailand
Renstar Medical Research

Ocala, Florida, 34470, United States
Royal Cornwall Hospital (Treliske)

Truro, TR1 3LJ, United Kingdom
SMS Medical College & Hospital

Jaipur, Rajasthan, 302004, India
Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orłowskiego Centrum Medycznego Kształcenia Podyplomowego

Warsaw, Masovian Voivodeship, 00-416, Poland
Sarawak General Hospital

Kuching, Sarawak, 93586, Malaysia
Selma Medical Associates

Winchester, Virginia, 22601-3834, United States
Selye János Kórház és Rendelőintézet

Komárom, 2900, Hungary
Seth GS medical college and KEM Hospital

Mumbai, Maharashtra, 400012, India
Siriraj Hospital_Bangkoknoi, Bangkok

Bangkoknoi, Bangkok, Bangkok, 10700, Thailand
Siriraj Hospital_Dept Endocrinology

Bangkok, 10700, Thailand
Southgate Medical Group, LLP

West Seneca, New York, 14224, United States
Southmead Hospital

Bristol, BS10 5NB, United Kingdom
Srinagarind Hospital

Khon Kaen, 40002, Thailand
St James's CRF

Dublin, Leinster, D08 A978, Ireland
St. Jos Heritage Hlthcr_Fllrtn

Fullerton, California, 92835, United States
Staploe Medical Centre

Soham, CB7 5JD, United Kingdom
StudyMetrix Research LLC

City of Saint Peters, Missouri, 63303, United States
Sunil's Diabetes Care n' Research Centre Pvt Ltd

Nagpur, Maharashtra, 440010, India
Sunil's Diabetes Care n' Research Centre Pvt Ltd

Nagpur, 440010, India
Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ

Szeged, Csongrád-Csanád, 6725, Hungary
Szőcs Depot Egészségügyi Szolgáltató Kft.

Budapest, 1042, Hungary
TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology

Aichi, 468-0009, Japan
Takatsuki Red Cross Hospital

Osaka, 569-1045, Japan
Terpa Sp. z o.o. Sp. k.

Lublin, Lubelskie Voivodeship, 20-333, Poland
Terpa Sp. z o.o. Sp. k.

Lublin, 20-333, Poland
Texas Diab & Endo, P.A.

Austin, Texas, 78731, United States
Texas Diab & Endo, P.A.

Austin, Texas, 78749, United States
Thammasat Hospital_Cardiology

Pathum Thani, 12120, Thailand
The Health Centre

Bradford-on-Avon, BA15 1DQ, United Kingdom
Tokuyama clinic_Diabetic internal medicine

Chiba, 261-0004, Japan
Trialmed CRS

Piotrkow Trybunalski, Łódź Voivodeship, 97-300, Poland
UT Southwestern Med Cntr

Dallas, Texas, 75390-9302, United States
University Technology MARA (UiTM) - Sg Buloh

Sungai Buloh, Selangor, 47000, Malaysia
Universitätsklinik für Innere Medizin Graz

Graz, 8036, Austria
Universitätsklinikum AKH Wien

Vienna, 1090, Austria
Universitätsklinikum Freiburg - Innere Medizin II

Freiburg im Breisgau, 79106, Germany
Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Podlaskie Voivodeship, 15-276, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, 15-276, Poland
Uniwersyteckie Centrum Kliniczne

Gdansk, Pomeranian Voivodeship, 80-214, Poland
Uniwersyteckie Centrum Kliniczne

Gdansk, 80-952, Poland
Velocity Clin Res Los Angeles

Los Angeles, California, 90017, United States
Velocity Clin Res Wstlke

Los Angeles, California, 90057, United States
Velocity Clinical Res-Dallas

Dallas, Texas, 75230, United States
Wendisch - Dahl Hamburg - DZHW

Hamburg, 22607, Germany
Wharton Med Clin Trials

Hamilton, Ontario, L8L 5G8, Canada
Zentrum fuer klinische Studien Suedbrandenburg GmbH

Elsterwerda, 04910, Germany
Zentrum für klinische Studien Alexander Segner

Saint Ingbert-Oberwürzbach, 66386, Germany
Zentrum für klinische Studien Allgäu Oberschwaben

Wangen, 88239, Germany

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