New combo shot CagriSema shows promise for diabetes and weight loss
NCT ID NCT06323161
First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times
Summary
This study tested a new investigational medicine called CagriSema, which combines two drugs (cagrilintide and semaglutide) in one weekly injection. It was given to 274 adults with type 2 diabetes who were already taking daily insulin, with or without metformin. The goal was to see if CagriSema could lower blood sugar and body weight better than a placebo. The study lasted about one year.
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 to help people with type 2 diabetes better control blood sugar and lose weight alongside their current insulin therapy.
- 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 it may not work for everyone. It is an add-on treatment, not a standalone cure.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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274 people
The number who actually took part.
- Started
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Mar 2024
- Finished
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Oct 2025
- Lead sponsor
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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
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Anyone
- Healthy volunteers
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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 Hide 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 (sex at birth). * Age 18 years or above at the time of signing the informed consent. * Diagnosed with type 2 diabetes mellitus ≥180 days before screening. * On stable once-daily dose of basal insulin (minimum of 0.25 units per kilogram per day (U/kg/day) or 20 U/day) alone or in combination with metformin (at effective or maximum tolerated dose as judged by the investigator) for 90 days prior to screening. * Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mole \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening. * Body Mass Index (BMI) greater than or equal to 25 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. Exclusion Criteria: * 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 (eGFR) less than 30 milliliters 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. * 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. * Known hypoglycaemia unawareness as indicated by the investigator according to Clarke's questionnaire question 8. * Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Akaicho Clinic
Chiba-shi, Chiba, 260-0804, Japan
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Alliance for Multispec Res
Newton, Kansas, 67114, United States
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Ashmed Medi-Centre
Cape Town, Western Cape, 7760, South Africa
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Bioclinical Research Alliance
Miami, Florida, 33155, United States
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Chinese People's Liberation Army General Hospital-Endocrinology
Beijing, Beijing Municipality, 100853, China
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Clinical Research Associates
Nashville, Tennessee, 37203, United States
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Clinical Trial Systems (CTC)
Pretoria, Gauteng, 0186, South Africa
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DIA - KONTROL s.r.o.
Levice, 93401, Slovakia
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Dr Noeth's Practice
Pretoria, 0002, South Africa
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Dr Vawda's site
Durban, KwaZulu-Natal, 4091, South Africa
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ENRIN, s.r.o.
Rimavská Sobota, 979 01, Slovakia
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Elite Research Center
Flint, Michigan, 48532, United States
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Endo and Metab Consultants
Rockville, Maryland, 20852, United States
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Fukuwa Clinic_Internal Medicine
Tokyo, 104-0031, Japan
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Futata Tetsuhiro Clinic Meinohama_Internal medicine
Fukuoka-shi, Fukuoka, 819-0006, Japan
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H.E.C Science Clinic
Kanagawa, 235-0045, Japan
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H.E.C Science Clinic_Internal Medicine, Diabetes
Kanagawa, 235-0045, Japan
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Healthcare centre Kragujevac
Kragujevac, RS, 34000, Serbia
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Healthcare centre Nis
Niš, RS, 18000, Serbia
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Healthcare centre Zvezdara
Belgrade, RS, 11050, Serbia
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Hemant Makan
Johannesburg, Gauteng, 1827, South Africa
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Holston Medical Group
Kingsport, Tennessee, 37660, United States
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Huaihe Hospital of Henan University
Kaifeng, Henan, 475000, China
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Huaihe Hospital of Henan University-Endocrinology
Kaifeng, Henan, 475000, China
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Iowa Diab & Endo Res Center
West Des Moines, Iowa, 50266, United States
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Jinan Central Hospital
Ji'nan, Shandong, 250013, China
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Jinan Central Hospital
Jinan, Shandong, 250013, China
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Kato Clinic of Internal Medicine_Internal Medicine
Tokyo, 125-0054, Japan
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Kumanomae Nishimura Naika Clinic_Internal Medicine
Arakawa-ku, Tokyo, 116-0012, Japan
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Kunisaki Makoto Clinic
Fukuoka-shi, Fukuoka, 819-0168, Japan
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Kyoto University Hospital_Department of Diabetes, Endocr
Kyoto-shi, Kyoto, 606-8507, Japan
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LUDIA, s. r. o.
Spišská Nová Ves, 05201, Slovakia
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Lenasia Clinical Trial Centre
Lenasia, Gauteng, 1827, South Africa
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MOMED, s.r.o
Kráľovský Chlmec, 077 01, Slovakia
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Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
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Manda Memorial Hospital_Internal Medicine
Sapporo-shi, Hokkaido, Hokkaido, Japan, 060-0062, Japan
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Minami Akatsuka Clinic_internal medicine
Mito-shi, Ibaraki, 311-4153, Japan
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Naka Kinen Clinic_Internal medicine
Ibaraki, 311-0113, Japan
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Oraderumaz (Pty) Ltd
Bloemfontein, Free State, 9301, South Africa
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Palm Research Center Inc.
Las Vegas, Nevada, 89128, United States
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PlanIt Research, PLLC
Houston, Texas, 77079, United States
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Policlinic for diabetes
Zaječar, 19000, Serbia
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Prinshof Medical Campus
Pretoria, Gauteng, 0002, South Africa
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SIN AZUCAR s.r.o.
Malacky, 901 01, Slovakia
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Sasaki Internal Medicine
Hokkaido, 062-0007, Japan
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Shanghai Pudong New Area People's Hospital-Endocrinology
Shanghai, Shanghai Municipality, 201200, China
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Simcare Medical Research, LLC
Sugar Land, Texas, 77478, United States
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Solaris Clinical Research
Meridian, Idaho, 83646, United States
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Synergy Groups Medical
Houston, Texas, 77061, United States
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TPMG Clinical Research
Newport News, Virginia, 23606, United States
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The Affiliated Hospital of Jiangsu University-Endocrinology
Zhenjiang, Jiangsu, 212001, China
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The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
Nanjing, Jiangsu, 210011, China
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The Second Affiliated Hospital of Nanjing Medical University_Nanjing
Nanjing, Jiangsu, 210011, China
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Tokyo-Eki Center-building Clinic
Tokyo, 103-0027, Japan
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Tokyo-Eki Center-building Clinic_Internal Medicine
Tokyo, 103-0027, Japan
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Tsuruma Kaneshiro Diabetes Clinic_Internal medicine
Yamato-shi, Kanagawa, 242-0004, Japan
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University Clinical Centre Nis
Niš, RS, 18 000, Serbia
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University of North Carolina
Chapel Hill, North Carolina, 27614, United States
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Valley Clinical Trials, Inc.
Northridge, California, 91325, United States
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Valley Research
Fresno, California, 93720, United States
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Velocity Clinical Res-Dallas
Dallas, Texas, 75230, United States
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