DRUG
Cagrilintide
Participants will receive cagrilintide s.c. once-weekly after a dose escalation period of 16 weeks for 219 weeks.
Status
Active, not recruiting
Phase
Phase 3
Enrollment
7,101
Locations
633
Results
Not posted
Publications
0
Study summary
This study will look at the effects of CagriSema on cardiovascular events (for example heart attack and stroke) in people living with cardiovascular disease. Participants will either get CagriSema or a dummy medicine (also called "placebo") which has no effect on the body. Which treatment participants will get will be decided by chance. Participant's chance of getting CagriSema or placebo is the same. Participants will inject the study medicine once a week. The study medicine will be injected briefly with a thin needle, typically in the stomach, thighs or upper arms. The study will last for up to 4.5 years.
Interventions
DRUG
Participants will receive cagrilintide s.c. once-weekly after a dose escalation period of 16 weeks for 219 weeks.
DRUG
Participants will receive semaglutide s.c. once-weekly after a dose escalation period of 16 weeks for 219 weeks.
DRUG
Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide subcutaneously.
Timeline
First posted
Jan 3, 2023
Study start
Mar 1, 2023
Primary completion
Sep 1, 2027
Study completion
Oct 13, 2027
Results posted
Not reported
Registry updated
Jul 17, 2026
Outcomes
Time to first occurrence of 3-point major adverse cardiovascular event (MACE), a composite endpoint consisting of: cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke
Time frame · From baseline (week 0) to end of study (up to 242 weeks or more)
Measured in days.
Time to first occurrence of a composite endpoint: Onset of persistent ≥40% reduction in eGFRcr (CKD-EPI), eGFRcr (CKD-EPI) <15 mL/min/1.73 m^2, Initiation of chronic kidney replacement therapy, Kidney death and CV death
Time frame · From baseline (week 0) to end of study (up to 242 weeks or more)
CKD-EPI is Chronic Kidney Disease Epidemiology Collaboration. Measured in days.
Time to first occurrence of composite endpoint consisting of: Onset of persistent macro albuminuria, ≥40% reduction in eGFRcr (CKD-EPI), eGFRcr (CKD-EPI) <15 mL/min/1.73 m^2, Initiation of chronic kidney replacement therapy and kidney death
Time frame · From baseline (week 0) to end of study (up to 242 weeks or more)
CKD-EPI is Chronic Kidney Disease Epidemiology Collaboration. Measured in days.
Time to first occurrence of an expanded 5-point MACE composite endpoint consisting of: CV death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation and unstable angina requiring hospitalisation
Time frame · From baseline (week 0) to end of study (up to 242 weeks or more)
Measured in days.
Time to first occurrence of a composite endpoint consisting of: all-cause death, non-fatal myocardial infarction and non-fatal stroke
Time frame · From baseline (week 0) to end of study (up to 242 weeks or more)
Measured in days.
Time to first occurrence of myocardial infarction (fatal and non-fatal)
Time frame · From baseline (week 0) to end of study (up to 242 weeks or more)
Measured in days.
Time to first occurrence of stroke (fatal and non-fatal)
Time frame · From baseline (week 0) to end of study (up to 242 weeks or more)
Measured in days.
Change in eGFRcr (CKD-EPI)
Time frame · From baseline (week 0) to 120 weeks
Measured in milliliter per min per 1.73 square meter (mL/min/1.73m\^2).
Ratio to baseline in Urine albumin-to-creatinine ratio (UACR)
Time frame · From baseline (week 0) to 120 weeks
Measured in ratio.
Relative change in body weight
Time frame · From baseline (week 0) to 120 weeks
Measured in percentage (%).
Change in waist circumference
Time frame · From baseline (week 0) to 120 weeks
Measured in centimeters (cm).
Eligibility
Inclusion Criteria: * Male or female * Age above or equal to 55 years at the time of signing informed consent * Body mass index (BMI) greater than or equal to (\>=) 25.0 kilograms per meter square (kg/m\^2) * Established CVD as evidenced by at least one of the following: 1. Prior myocardial infarction 2. Prior stroke (ischemic or haemorrhagic stroke) 3. Symptomatic peripheral arterial disease (PAD) defined as at least one of the following: 1. Intermittent claudication with an ankle-brachial index (ABI) less than (\<) 0.85 at rest 2. Intermittent claudication with a \>= 50% stenosis in a lower extremity peripheral artery documented by X-ray angiography, magnetic resonance (MR) angiography, computed tomography (CT) angiography or Doppler ultrasound 3. Prior revascularization procedure of a lower extremity peripheral artery 4. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g., trauma or osteomyelitis) For participants with T2D at screening the following inclusion criteria also apply: * Diagnosed with type 2 diabetes mellitus (T2D) \>= 180 days before screening * HbA1c 6.5%-10% (47-86 millimoles per mole \[mmol/mol\]) (both inclusive), as measured by central laboratory at screening * Treatment with either: 1. Lifestyle intervention alone 2. 1-3 marketed oral antidiabetic drugs (OADs) (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), dipeptidyl peptidase 4 (DPP4)-inhibitors, thiazolidinediones, or sulphonylureas (SU) as a single agent or in combination) according to local label 3. Basal insulin alone or in combination with up to two marketed OADs, all according to local label Exclusion Criteria: * Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 60 days before screening * Planned coronary, carotid or peripheral artery revascularisation known on the day of screening * Heart failure classified as being in New York Heart Association (NYHA) Class IV at screening * Treatment with any glucagon-like peptide-1 (GLP-1) receptor agonist (RA) or a medication with GLP-1 activity within 90 days before screening * End stage renal disease defined as estimated glomerular filtration rate (eGFR) \< 15 millileters per minutes per 1.73\^2 (mL/min/1.73 m\^2), as measured by the central laboratory at screening * Chronic or intermittent haemodialysis or peritoneal dialysis
Study locations
Argentina · Australia · Brazil · Bulgaria · Canada · Colombia · Denmark · France · Germany · India · Ireland · Italy · Japan · Malaysia · Mexico · Netherlands · Poland · Puerto Rico · Serbia · South Africa · Spain · Thailand · Turkey (Türkiye) · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Univ of Alabama Birmingham
Birmingham, Alabama, United States
Chambliss Clinical Trials LLC
Montgomery, Alabama, United States
Honor Health
Scottsdale, Arizona, United States
National Heart Institute Cal
Beverly Hills, California, United States
Valley Clinical Trials
Covina, California, United States
Scripps Wht Diab Inst La Jolla
La Jolla, California, United States
First Valley Medical Group
Lancaster, California, United States
Clinical Trials Research_Sacramento
Lincoln, California, United States
Torrance Clin Res Inst, Inc.
Lomita, California, United States
Pacific Clinical Studies
Los Alamitos, California, United States
Monterey Endocrine & Diabetes Institute, Inc
Monterey, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Desert Oasis Hlthcr Med Group
Palm Springs, California, United States
Western University of Health Sciences
Pomona, California, United States
Linda Vista Health Care Ctr
San Diego, California, United States
N America Res Inst - San Dimas
San Dimas, California, United States
Encompass Clinical Research_Spring Valley
Spring Valley, California, United States
Lundquist Inst.-Biom Inno-UCLA
Torrance, California, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
Innovative Research of W FL
Clearwater, Florida, United States
Florida Premier Cardiology
Delray Beach, Florida, United States
Fleming Island Center for Clinical Research
Fleming Island, Florida, United States
Life Spring Research Foundation LLC
Miami, Florida, United States
Oceane 7 Medical & Research Center, Inc.
Miami, Florida, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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