DRUG
Cagrilintide
Cagrilintide administered subcutaneously (s.c., under the skin) once-weekly
A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight
Status
Completed
Phase
Phase 3
Enrollment
1,200
Locations
179
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
This study will look at how well the new medicine CagriSema helps people living with excess body weight and type 2 diabetes losing weight. Participants will either get CagriSema or a dummy medicine. Which treatment they get is decided by chance. The study will last for about 1½ years. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.
Interventions
Treatment arms and agents.
DRUG
Semaglutide
Semaglutide administered subcutaneously (s.c., under the skin) once-weekly
DRUG
Placebo cagrilintide
Placebo cagrilintide administered subcutaneously (s.c., under the skin) once-weekly
DRUG
Placebo semaglutide
Placebo semaglutide administered subcutaneously (s.c., under the skin) once-weekly
Timeline
From registration to results.
First posted
May 27, 2022
Study start
Feb 1, 2023
Primary completion
Jan 28, 2025
Study completion
Feb 3, 2025
Results posted
Not reported
Registry updated
Jan 28, 2026
Outcomes
What the study measures.
Primary outcomes
Relative change in body weight
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in percentage (%).
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.
Secondary outcomes
Achievement of ≥ 20% weight reduction
Time frame · From baseline (week 0) to end of treatment (week 68)
Count of participant.
Relative change in body weight
Time frame · From baseline (week 0) to week 20
Measured in %.
Change in waist circumference
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in centimeter (cm).
Change in Glycated Haemoglobin (HbA1c)
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in %-points.
Change in Systolic Blood Pressure (SBP)
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in millimeter of mercury (mmHg).
Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in score points.
Change in Short Form-36 Version 2.0 Health Survey Acute (SF-36v2 Acute) Physical Functioning score
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in score points.
Change in body weight
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in kilogram (kg).
Change in body mass index (BMI)
Time frame · From baseline (week 0) to end of treatment (week 68)
Measured in kilogram per meter square (kg/m\^2).
Improvement in weight category (BMI, underweight below 18.5, normal weight 18.5 to below 25, overweight 25.0 to below 30, obesity class I 30 to below 35, obesity class II 35 to below 40, obesity class III above 40)
Time frame · From baseline (week 0) to end of treatment (week 68)
Count of participant.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Male or female * Age above or equal to 18 years at the time of signing informed consent * BMI greather than or equal to 27.0 kg/m\^2 * Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening * Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulphonylureas (SU)s as a single agent or in combination) according to local label * Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening * HbA1c 7%-10% (53-86 mmol/mol) (both inclusive) as measured by the central laboratory at screening Exclusion Criteria: * Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness * Renal impairment with estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m\^2, as measured by the central laboratory at screening * 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
179 registered sites.
Austria · Canada · Germany · Hungary · India · Ireland · Japan · Malaysia · Poland · Puerto Rico · Thailand · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
John Muir Physicians Network
Concord, California, United States
Headlands Research California, LLC
Escondido, California, United States
Providence Medical Foundation
Fullerton, California, United States
St. Jos Heritage Hlthcr_Fllrtn
Fullerton, California, United States
Diabetes/Lipid Mgmt & Res Ctr
Huntington Beach, California, United States
Clinical Trials Research
Lincoln, California, United States
Velocity Clin Res Los Angeles
Los Angeles, California, United States
Velocity Clin Res Wstlke
Los Angeles, California, United States
Desert Oasis Hlthcr Med Group
Palm Springs, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
New West Physicians,Inc.
Golden, Colorado, United States
Clinical Res Of W Florida Inc
Clearwater, Florida, United States
Northeast Research Institute
Fleming Island, Florida, United States
Jacksonville Ctr For Clin Res
Jacksonville, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
AdventHealth Diab Inst
Orlando, Florida, United States
Florida Institute for Clinical Research, LLC
Orlando, Florida, United States
Oviedo Medical Research, LLC
Oviedo, Florida, United States
Endo Res Solutions Inc
Roswell, Georgia, United States
East West Med Res Inst
Honolulu, Hawaii, United States
Cedar-Crosse Research Center
Chicago, Illinois, United States
Iowa Diab & Endo Res Center
West Des Moines, Iowa, United States
Cotton-Oneill Diabetes and End
Topeka, Kansas, United States
L-MARC Research Center
Louisville, Kentucky, United States
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
Novo Nordisk · Obesity · Type 2 Diabetes
Phase 3
Recruiting
2,500
2026-07
A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term
Novo Nordisk · Obesity
Phase 3
Active, not recruiting
609
2026-07
A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight
Novo Nordisk · Obesity
Phase 3
Active, not recruiting
3,400
2026-07
REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels
Novo Nordisk · Cardiovascular Disease
Phase 3
Active, not recruiting
7,101
2026-07
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
Novo Nordisk · Diabetes Mellitus, Type 2
Phase 3
Completed
1,023
2026-07
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
Novo Nordisk · Overweight · Obesity
Phase 3
Recruiting
460
2026-07
A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes
Novo Nordisk · Diabetes Mellitus, Type 2
Phase 2
Withdrawn
0
2026-07
A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight
Novo Nordisk · Overweight · Obesity
Phase 3
Withdrawn
0
2026-07
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