DRUG
Cagrilintide
Participants will receive once-weekly cagrilintide subcutaneously.
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Diet and Exercise
Status
Completed
Phase
Phase 3
Enrollment
189
Locations
50
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
This study will look at how much CagriSema helps participants 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. Participants will get either CagriSema or "dummy" medicine. Which treatment participants get is decided by chance. For each participant, the study will last for about one year.
Interventions
Treatment arms and agents.
DRUG
Semaglutide
Participants will receive once-weekly semaglutide subcutaneously.
DRUG
Placebo
Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously.
Timeline
From registration to results.
First posted
Mar 21, 2024
Study start
Mar 19, 2024
Primary completion
Oct 1, 2025
Study completion
Dec 22, 2025
Results posted
Not reported
Registry updated
Apr 2, 2026
Outcomes
What the study measures.
Primary outcomes
Change in glycated haemoglobin (HbA1c)
Time frame · From baseline (week 0) to end of treatment (week 40)
Measured as percentage (%)-points.
Secondary outcomes
Relative change in body weight
Time frame · From baseline (week 0) to end of treatment (week 40)
Measured in %.
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 millimoles 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 in millimoles per liter (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.
Number of participants who achieve >=20% body weight reduction
Time frame · From baseline (week 0) to end of treatment (week 40)
Measured as count of participants.
Change in waist circumference
Time frame · From baseline (week 0) to end of treatment (week 40)
Measured in centimeters (cm).
Change in systolic blood pressure (SBP)
Time frame · From baseline (week 0) to end of treatment (week 40)
Measured in millimeters of mercury (mmHg).
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Male or female * Age 18 years or above at the time of signing the informed consent * Diagnosed with type 2 diabetes \>=30 days before screening * HbA1c 7.0-9.5 percent (53-80 millimoles per mole \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening * Body mass index (BMI) \>=23 kilograms 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 less than 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 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 * History of use of any injectable therapy for diabetes or obesity. 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 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
Study locations
50 registered sites.
China · Hungary · Italy · Poland · Saudi Arabia · Serbia · United States. Showing up to 24 locations stored in the fast local snapshot.
Nat Res Inst Huntington Park
Huntington Park, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Southern California Dermatology
Santa Ana, California, United States
Encore Medical Research LLC
Hollywood, Florida, United States
Headlands Research Orlando
Orlando, Florida, United States
Encore Medical Research of Weston
Weston, Florida, United States
Alliance for Multispec Res
Newton, Kansas, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Arcturus HC PLC Troy Med Res
Troy, Michigan, United States
Southgate Medical Group, LLP
West Seneca, New York, United States
Summit Research Network Oregon Inc.
Portland, Oregon, United States
Holston Medical Group
Kingsport, Tennessee, United States
Amarillo Medical Specialists
Amarillo, Texas, United States
Elligo Clin Res Centre
Austin, Texas, United States
Headlands Research Brownsville
Brownsville, Texas, United States
Velocity Clinical Res-Dallas
Dallas, Texas, United States
Northeast Clinical Research of San Antonio
San Antonio, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Sugar Lakes Family Practice PA
Sugar Land, Texas, United States
Valley Diab. & Endo Comp Ctr
Weslaco, Texas, United States
TPMG Clinical Research
Newport News, Virginia, United States
Chinese People's Liberation Army General Hospital-Endocrinology
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
Nanjing, Jiangsu, China
The Affiliated Hospital of Jiangsu University-Endocrinology
Zhenjiang, Jiangsu, China
Related trials
More studies on Cagrilintide.
NCT IDStudyPhase / statusEnrollmentUpdated
A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight
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A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term
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REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels
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A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both
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A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
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A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes
Novo Nordisk · Diabetes Mellitus, Type 2
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Withdrawn
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2026-07
A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight
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Withdrawn
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