DRUG
CagriSema
Cagrilintide and Semaglutide will be administered subcutaneously using device 1 or device 2.
Status
Withdrawn
Phase
Phase 2
Enrollment
0
Locations
61
Results
Not posted
Publications
0
Study summary
This study is being done to look at how well a study medicine called CagriSema helps people with diabetes lower their blood sugar. In this study the sponsor will compare two version of CagriSema injected by two different types of injection devices. Which treatment participants get is decided by chance. CagriSema is still being tested in studies and is not yet available for doctors to prescribe. The study will last for about 38 weeks.
Interventions
DRUG
Cagrilintide and Semaglutide will be administered subcutaneously using device 1 or device 2.
DRUG
Placebo matched to Cagrilintide and Placebo matched to Semaglutide will be administered subcutaneously using device 1 or device 2.
Timeline
First posted
Jan 22, 2026
Study start
Aug 27, 2026
Primary completion
Aug 25, 2027
Study completion
Oct 13, 2027
Results posted
Not reported
Registry updated
Jul 9, 2026
Outcomes
Change in glycated haemoglobin (HbA1c)
Time frame · Baseline to week 28
Measured as percentage-points (%-points).
Weekly average cagrilintide (total) and semaglutide concentration (Cavg) based on population pharmacokinetic analyses
Time frame · From baseline to week 28
Measured in nanomoles per litre (nmol/L).
Change in HbA1c
Time frame · From baseline to week 28
Measured as %-points.
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame · From baseline to week 35
Measured as count of events.
Number of clinically significant hypoglycaemic episodes (level 2) (less than [<] 3.0 millimoles per litre [mmol/L]), confirmed by blood glucose (BG) meter, or severe hypoglycaemic episodes (level 3)
Time frame · From baseline to week 35
Measured as count of episodes.
Eligibility
Inclusion Criteria * Male or female (sex assigned at birth, inclusive of all gender identities). * Age 18-64 years (both inclusive) at the time of signing the informed consent. * Diagnosed with type 2 diabetes mellitus greater than or equal to (\>=) 180 days before screening. * Glycated haemoglobin (HbA1c) 7.0-10.5 percent (%) (53-91 \[millimoles per mole\] mmol/mol) (both inclusive) as determined by the central laboratory at screening. * Stable daily dose \>= 90 days before screening of metformin at effective or maximum tolerated dose as judged by the investigator. * Body mass index (BMI) between 25.0 and 39.9 kilograms per square metre (kg/m\^2) (both inclusive) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening. Exclusion Criteria: * Renal impairment with estimated Glomerular Filtration Rate (eGFR) \< 30 millilitre per minute per 1.73 square metre (mL/min/1.73 m\^2) as determined by the 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. * 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. * Previous exposure to CagriSema in a clinical study.
Study locations
Denmark · Greece · Malaysia · Serbia · Slovakia · Spain · Thailand · United States. Showing up to 24 locations stored in the fast local snapshot.
Arkansas Clinical Research
Little Rock, Arkansas, United States
Paradigm Clinical Research
San Diego, California, United States
Encompass Clinical Research_Spring Valley
Spring Valley, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Future Medical Research
Longwood, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Clinical Site Partners Kendall Flourish Research
Miami, Florida, United States
West Orange Endocrinology
Ocoee, Florida, United States
Center for Diab,Obes & Metab
Pembroke Pines, Florida, United States
American Research Centers of Florida
Pembroke Pines, Florida, United States
Hope Clin Res & Wellness
Conyers, Georgia, United States
Elevate Clinical Research
Gurnee, Illinois, United States
Accellacare of Duly Oak Lawn
Oak Lawn, Illinois, United States
KDCILM, LLC & Accellacare US, Inc.
Wilmington, North Carolina, United States
Advanced Medical Research - Maumee
Maumee, Ohio, United States
Clinical Res Collaborative
Cumberland, Rhode Island, United States
Clinical Research Associates
Nashville, Tennessee, United States
The Endocrine Center
Houston, Texas, United States
Radiance Clinical Research
Lampasas, Texas, United States
Quality Research Inc
San Antonio, Texas, United States
Medrasa Clinical Research
Sherman, Texas, United States
Sanos Clinic - Vejle
Vejle, Region Syddanmark, Denmark
Sanos Clinic - Gandrup
Gandrup, Denmark
Sanos Clinic - Herlev
Herlev, Denmark
Publications
No PMID-linked publications were present in this registry snapshot.
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