DRUG
Cagrilintide
Cagrilintide will be administered subcutaneously.
Status
Completed
Phase
Phase 3
Enrollment
1,024
Locations
196
Results
Not posted
Publications
0
Study summary
This study will look at how well CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide that doctors may prescribe in some countries. Participants will get either CagriSema or tirzepatide. Which treatment participant get is decided by chance like flipping a coin. Participant will have an equal chance of receiving either drug. For each participant, the study will last for up to one and a half years.
Interventions
DRUG
Cagrilintide will be administered subcutaneously.
DRUG
Semaglutide will be administered subcutaneously.
DRUG
Tirzepatide will be administered subcutaneously.
Timeline
First posted
Jan 24, 2024
Study start
Jan 16, 2024
Primary completion
Mar 4, 2026
Study completion
Apr 6, 2026
Results posted
Not reported
Registry updated
Apr 22, 2026
Outcomes
Change in glycated haemoglobin (HbA1c)
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in percentage (%)-points.
Relative change in body weight
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in percentage (%).
Change in HbA1c
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in %-points.
Change in fasting plasma glucose (FPG)
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in millimoles per liter (mmol/L).
Achievement of HbA1c target values of less than (<) 7.0% (<53 millimole per mole [mmol/mol])
Time frame · At end of treatment (week 68)
Count of participant
Achievement of HbA1c target values of less than or equal to (≤) 6.5% (≤ 48 mmol/mol)
Time frame · From baseline (week 0) to end of treatment (week 68)
Count of participant
Achievement of greater than or equal to (≥) 5% weight reduction
Time frame · From baseline (week 0) to end of treatment (week 68)
Count of participant
Achievement of ≥ 10% weight reduction
Time frame · From baseline (week 0) to end of treatment (week 68)
Count of participant
Achievement of ≥ 15 % weight reduction
Time frame · From baseline (week 0) to end of treatment (week 68)
Count of participant
Achievement of ≥ 20 % weight reduction
Time frame · From baseline (week 0) to end of treatment (week 68)
Count of participant
Change in systolic blood pressure
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in millimeters of mercury(mmHg).
Change in diastolic blood pressure
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in mmHg.
Eligibility
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 ≥ 180 days before screening. * Stable daily dose(s) ≥ 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without an sodium-glucose co-transporter-2 (SGLT2) inhibitor. * HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at screening. * Body mass index (BMI) of ≥ 30.0 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 \< 30 milliliter 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. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed. * 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.
Study locations
Argentina · Australia · Canada · Colombia · India · South Africa · Taiwan · United States. Showing up to 24 locations stored in the fast local snapshot.
Synexus Clin Res-Birmingham
Birmingham, Alabama, United States
Univ of Alabama_Birmingham
Birmingham, Alabama, United States
Prime Medical Group, LLC
Gilbert, Arizona, United States
Velocity Clinical Research-Phoenix
Phoenix, Arizona, United States
Synexus Rsch /Cnt Phnx Med C
Phoenix, Arizona, United States
Arkansas Clinical Research
Little Rock, Arkansas, United States
Unity Health-Searcy Medical Center
Searcy, Arkansas, United States
Velocity Clin Res-Chula Vista
Chula Vista, California, United States
Headlands Research California, LLC
Escondido, California, United States
Neighborhood Healthcare
Escondido, California, United States
St. Jude Heritage Yorba Linda - Pediatric Ste D
Fullerton, California, United States
Diabetes & Endocrine Specialists - La Mesa
La Mesa, California, United States
Diabetes and Endocrine Specialists - La Mesa
La Mesa, California, United States
Velocity Clin Res San Diego
La Mesa, California, United States
Clinical Trials Research
Lincoln, California, United States
Loma Linda Univ Hlth Cr Endo
Loma Linda, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Desert Oasis Healthcare
Palm Springs, California, United States
Velocity Clin Res - Panorama
Panorama City, California, United States
Western University of Health Sciences
Pomona, California, United States
Endocrinology Josel Cabaccan
San Jose, California, United States
Mills-Peninsula Medical Center
San Mateo, California, United States
NorCal Endocrinology and Internal Medicine
San Ramon, California, United States
Premier Medical Center, Inc.
Toluca Lake, California, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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