DRUG
Cagrilintide
Participants will receive once-weekly cagrilintide subcutaneously.
Status
Completed
Phase
Phase 3
Enrollment
274
Locations
53
Results
Not posted
Publications
1
Study summary
This study will look at how much 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 "dummy" medicine (also called "placebo") that has no effect on the body. Participant will get either CagriSema or "dummy" medicine and which treatment they get is decided by chance. Participant will take the study medicine together with their current diabetes medicine (once-daily insulin with or without metformin). For each participant, the study will last for about one year.
Interventions
DRUG
Participants will receive once-weekly cagrilintide subcutaneously.
DRUG
Participants will receive once-weekly semaglutide subcutaneously.
DRUG
Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously.
Timeline
First posted
Mar 21, 2024
Study start
Mar 26, 2024
Primary completion
Sep 9, 2025
Study completion
Oct 23, 2025
Results posted
Not reported
Registry updated
Nov 28, 2025
Outcomes
Change in Glycated Haemoglobin (HbA1c)
Time frame · From baseline (week 0) to end of treatment (week 40)
Measured in percentage (%)- points.
Relative Change in Body Weight
Time frame · From baseline (week 0) to end of treatment (week 40)
Measured in percentage (%).
Number of Participants Who Achieve Greater than or Equal to (≥) 10% Body Weight Reduction
Time frame · From baseline (week 0) to end of treatment (week 40)
Measured as count of participants.
Number of Participants Who Achieve ≥15% Body Weight Reduction
Time frame · From baseline (week 0) to end of treatment (week 40)
Measured as count of participants.
Number of Participants Who Achieve HbA1c Target Values of Less than (<) 7.0% (<53 millimole per mole [mmol/mol])
Time frame · At end of treatment (week 40)
Measured as count of participants.
Number of Participants Who Achieve HbA1c Target Values of Less than or Equal to (≤) 6.5% (≤48 mmol/mol)
Time frame · At end of treatment (week 40)
Measured as count of participants.
Change in Fasting Plasma Glucose (FPG)
Time frame · From baseline (week 0) to end of treatment (week 40)
Measured as millimole per liter (mmol/L).
Change in Insulin Dose
Time frame · From baseline (week 0) to end of treatment (week 40)
Measured in units (u).
Number of Participants Who Achieve Insulin Dose Equal to (=) 0 Units
Time frame · At end of treatment (week 40)
Measured as count of participants.
Change in 7-point Self-measured Plasma Glucose (SMPG) Profiles: Mean 7-point profile and Mean postprandial increment (over all meals)
Time frame · From baseline (week 0) to end of treatment (week 40)
Measured in mmol/L.
Number of Participants Who Achieve ≥5% Body Weight Reduction
Time frame · From baseline (week 0) to end of treatment (week 40)
Measured as count of participants.
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 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.
Study locations
China · Japan · Serbia · Slovakia · South Africa · United States. Showing up to 24 locations stored in the fast local snapshot.
Valley Clinical Trials, Inc.
Northridge, California, United States
Bioclinical Research Alliance
Miami, Florida, United States
Solaris Clinical Research
Meridian, Idaho, United States
Iowa Diab & Endo Res Center
West Des Moines, Iowa, United States
Alliance for Multispec Res
Newton, Kansas, United States
Elite Research Center
Flint, Michigan, United States
Palm Research Center Inc.
Las Vegas, Nevada, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Clinical Research Associates
Nashville, Tennessee, United States
Velocity Clinical Res-Dallas
Dallas, Texas, United States
Synergy Groups Medical
Houston, Texas, United States
PlanIt Research, PLLC
Houston, Texas, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
TPMG Clinical Research
Newport News, Virginia, United States
Chinese People's Liberation Army General Hospital-Endocrinology
Beijing, Beijing Municipality, China
Huaihe Hospital of Henan University-Endocrinology
Kaifeng, Henan, China
Huaihe Hospital of Henan University
Kaifeng, Henan, China
The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University_Nanjing
Nanjing, Jiangsu, China
The Affiliated Hospital of Jiangsu University-Endocrinology
Zhenjiang, Jiangsu, China
Jinan Central Hospital
Ji'nan, Shandong, China
Jinan Central Hospital Affiliated to Shandong University
Jinan, Shandong, China
Shanghai Pudong New Area People's Hospital-Endocrinology
Shanghai, Shanghai Municipality, China
Manda Memorial Hospital_Internal Medicine
Sapporo-shi, Hokkaido, Hokkaido, Japan, Japan
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